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Author, Year,
Study Design,
Class, Rating
Population
Intervention Group = 21
age 51.92.2
Class: A
Rating: Neutral
N= 1897
Study Design:
Cross-Sectional
Study
Class: D
Rating: Positive
Non-diabetic Group=
918 Age 65 10.1
Intervention
Outcomes
Conclusions
Limitations
Participants
were randomly
assigned to
receive either
5.1 g psyllium
(Intervention
Group) or a
microcrystalline
cellulose
placebo (Control
Group) once
before breakfast
and once before
dinner for 8weeks on top of
their regular
diets and
chemical drugs.
Not Applicable.
5.1 g b.i.d. of
psyllium is useful
as an adjunct to
dietary therapy and
to reduce glucose
in patients with
type II diabetes.
Participant
demographic
information wasnt
disclosed, including
gender.
The Non-Diabetic
group was about 10
years older than the
Diabetic Group.
Author, Year,
Study Design,
Class, Rating
Lubia VelzquezLpez, Abril Violeta
Muoz-Torres,
Carmen GarcaPea, Mardia
Lpez-Alarcn,
Sergio IslasAndrade, and Jorge
Escobedo-de la
Pea, 2016
Study Design: Cross
Sectional Study
Class: D
Rating: Neutral
Population
N= 395
Type 2
diabetic
Mexican
patients, <70
years old,
54.6 +/- 8
years
average age,
Mexico
City, part of
another
randomized
clinical trial
Intervention
Outcomes
HbA1c, fasting
glucose,
triglycerides,
and lipids
profile were
measured.
Weight, waist
circumference,
blood
pressure, and
body
composition
were
measured.
Everyday
diet with a
semiquantitative
food
frequency
questionnaire
was evaluated.
The
participants
followed
their current
everyday
diet.
Conclusions
A higher
content of
fiber in the diet
had an impact
on
reducing
HbA1c and
triglycerides,
while
improving
HDL-c
levels.
Limitations
Looked at
one race of
people.
No specific
diet was
given.
Author, Year,
Study Design,
Class, Rating
Manisha Chanalia
,M.D.,Abhimanyu
Garg,M.D., Dieter
Lutjhonatann,PH.D.,
Klaus von
BErgmann,M.D.,
Scott
M.Grundy,M.D.,Ph.
d.,and Linda J.
Brinkley, R. D.
(2015).
Study Design:
Randomized
Crossover Study
Class: A
Rating: Neutral
Population
N=13; 12 male, 1
female; 61
9 years (4570), 9 nonHispanic whites/4
blacks: mean
body weight: 93.5 12.7
kg;
mean body mass index:
32.3 3.9;
Dallas, USA
Intervention
High-fiber diet
containing 50g
total
fiber (25g
soluble, 25g
insoluble)
vs.ADA diet
containing 24g
of total
fiber (8g
soluble, 16g
insoluble)
Outcomes
Conclusions
Limitations
High-fiber diet
improved
Glycemic control,
lowered
Glycosylated
hemoglobin
values;
specifically,
increase in intake
of total
dietary fiber which
consists
predominantly of
soluble fiber,
significantly
improved glycemic
control and
decreased degree
of
hyperinsulinemia
in patients with
type 2 diabetes.
Author, Year,
Study Design,
Class, Rating
Population
Intervention
Outcomes
Conclusions
Limitations
40 patients
received either
no extra fiber
compared to the
ADA diet and
80 patients
received either
10g of dietary
fiber or 20g of
dietary fiber in
addition to the
ADA diet
Diabetic control
status was
observed among
patients with
DM2 and those
without in
association to
dietary factors
Regardless of
duration of DM2,
HbA1c levels were
consistently lower
in patients
consuming higher
amounts of DF
Study Design:
Randomized,
controlled
experiment
Class: A
Rating: Positive
Citation
Ziai,
S.
A.,
Larijani,
B.,
Akhoondzadeh,
S.,
Fakhrzadeh,
H.,
Dastpak,
A.,
Bandarian,
F.,
Emami,
T.
(2005).
Psyllium
decreased
serum
glucose
and
glycosylated
hemoglobin
significantly
in
diabetic
outpatients.
Journal
of
Ethnopharmacology,
102(2),
202207.
http://doi.org/10.1016/j.jep.2005.06.042
(completed
by
Ariel
Robinson)
Study Design
Class
Quality
Rating
Research
Purpose
Inclusion
Criteria
Exclusion Criteria
+ (Positive)
- (Negative)
x (Neutral)
Description
of
Study
Protocol
Data
Collection
Summary
Timing
of
Measurements:
All
participants
were
seen
two
weeks
apart,
starting
at
baseline
(week
0).
Dependent
Variables:
Body
weight,
blood
preassure,
fasting
serum
levels
of
Other
Findings:
This
intervention
reduced
TB
non-significantly
but
had
no
effect
on
the
total
cholesterol
and
LDL-C.
HDL-C
increased
in
the
intervention
group.
5.1
g
b.i.d.
of
psyllium
is
useful
as
an
adjunct
to
deitary
therapy
in
patients
with
Author
Conclusion
Reviewer
Comments
Funding Source
Medical Sciences
Explanation
Positive
Indicates
that
the
report
has
clearly
addressed
issues
of
inclusion/exclusion,
bias,
generalizability,
and
data
collection
and
analysis
Negative
Indicates
that
these
issues
have
not
been
adequately
addressed.
Neutral
indicates
that
the
report
is
neither
exceptionally
strong
nor
exceptionally
week
Select
a
rating
from
the
drop-down
menu
Relevance
Questions
1. Would
implementing
the
studied
intervention
or
procedure
(if
found
successful)
result
in
improved
outcomes
for
the
patients/clients/population
group?
(NA
for
some
Epi
studies)
2. Did
the
authors
study
an
outcome
(dependent
variable)
or
topic
that
the
patients/clients/population
group
would
care
about?
3. Is
the
focus
of
the
intervention
or
procedure
(independent
variable)
or
topic
of
study
a
Yes
Yes
Yes
Yes
If
the
answers
to
all
of
the
above
relevance
questions
are
Yes,
the
report
is
eligible
for
designation
with
a
plus
(+)
on
the
Evidence
Quality
Worksheet,
depending
on
answers
to
the
following
validity
questions.
Validity
Questions
1. Was
the
research
question
clearly
stated?
1.1. Was
the
specific
intervention(s)
or
procedure
(independent
variable(s))
identified?
1.2. Was
the
outcome(s)
(dependent
variable(s))
clearly
indicated?
1.3. Were
the
target
population
and
setting
specified?
2. Was
the
selection
of
study
subjects/patients
free
from
bias?
2.1. Were
inclusion/exclusion
criteria
specified
(e.g.,
risk,
point
in
disease
progression,
diagnostic
or
prognosis
criteria),
and
with
sufficient
detail
and
without
omitting
criteria
critical
to
the
study?
2.2. Were
criteria
applied
equally
to
all
study
groups?
2.3. Were
health,
demographics,
and
other
characteristics
of
subjects
described?
2.4. Were
the
subjects/patients
a
representative
sample
of
the
relevant
population?
3. Were
study
groups
comparable?
3.1. Was
the
method
of
assigning
subjects/patients
to
groups
described
and
unbiased?
(Method
of
randomization
identified
if
RCT)
3.2. Were
distribution
of
disease
status,
prognostic
factors,
and
other
factors
(e.g.,
demographics)
similar
across
study
groups
at
baseline?
3.3. Were
concurrent
controls
used?
(Concurrent
preferred
over
historical
controls.)
3.4. If
cohort
study
or
cross-sectional
study,
were
groups
comparable
on
important
confounding
factors
and/or
were
preexisting
differences
accounted
for
by
using
appropriate
adjustments
in
statistical
analysis?
3.5. If
case
control
study,
were
potential
confounding
factors
comparable
for
cases
and
controls?
(If
case
series
or
trial
with
subjects
serving
as
own
control,
this
criterion
is
not
applicable.
Criterion
may
not
be
applicable
in
some
cross-
sectional
studies.)
3.6. If
diagnostic
test,
was
there
an
independent
blind
comparison
with
an
appropriate
reference
standard
(e.g.,
gold
standard)?
1.3
Yes
Yes
Yes
Unclear
Yes
2.1
Unclear
2.2
Yes
2.3
No
2.4
Unclear
Yes
3.1
Yes
3.2
Unclear
3.3
Yes
3.4
Yes
3.5
N/A
3.6
N/A
Yes
4.1
Unclear
4.2
Yes
4.3
Yes
4.4
No
4.5
N/A
Yes
5.1
Yes
5.2
Yes
5.3
No
1
1.1
1.2
4. Was
method
of
handling
withdrawals
described?
4.1. Were
follow
up
methods
described
and
the
same
for
all
groups?
4.2. Was
the
number,
characteristics
of
withdrawals
(i.e.,
dropouts,
lost
to
follow
up,
attrition
rate)
and/or
response
rate
(cross-sectional
studies)
described
for
each
group?
(Follow
up
goal
for
a
strong
study
is
80%.)
4.3. Were
all
enrolled
subjects/patients
(in
the
original
sample)
accounted
for?
4.4. Were
reasons
for
withdrawals
similar
across
groups
4.5. If
diagnostic
test,
was
decision
to
perform
reference
test
not
dependent
on
results
of
test
under
study?
5. Was
blinding
used
to
prevent
introduction
of
bias?
5.1. In
intervention
study,
were
subjects,
clinicians/practitioners,
and
investigators
blinded
to
treatment
group,
as
appropriate?
5.2. Were
data
collectors
blinded
for
outcomes
assessment?
(If
outcome
is
measured
using
an
objective
test,
such
as
a
lab
value,
this
criterion
is
assumed
to
be
met.)
5.3. In
cohort
study
or
cross-sectional
study,
were
measurements
of
outcomes
and
risk
factors
blinded?
5.4. In
case
control
study,
was
case
definition
explicit
and
case
ascertainment
not
influenced
by
exposure
status?
5.5. In
diagnostic
study,
were
test
results
blinded
to
patient
history
and
other
test
results?
6. Were
intervention/therapeutic
regimens/exposure
factor
or
procedure
and
any
comparison(s)
described
in
detail?
Were
intervening
factors
described?
6.1. In
RCT
or
other
intervention
trial,
were
protocols
described
for
all
regimens
studied?
6.2. In
observational
study,
were
interventions,
study
settings,
and
clinicians/provider
described?
6.3. Was
the
intensity
and
duration
of
the
intervention
or
exposure
factor
sufficient
to
produce
a
meaningful
effect?
6.4. Was
the
amount
of
exposure
and,
if
relevant,
subject/patient
compliance
measured?
6.5. Were
co-interventions
(e.g.,
ancillary
treatments,
other
therapies)
described?
6.6. Were
extra
or
unplanned
treatments
described?
6.7. Was
the
information
for
6.4,
6.5,
and
6.6
assessed
the
same
way
for
all
groups?
6.8. In
diagnostic
study,
were
details
of
test
administration
and
replication
sufficient?
7. Were
outcomes
clearly
defined
and
the
measurements
valid
and
reliable?
7.1. Were
primary
and
secondary
endpoints
described
and
relevant
to
the
question?
7.2. Were
nutrition
measures
appropriate
to
question
and
outcomes
of
concern?
7.3. Was
the
period
of
follow-up
long
enough
for
important
outcome(s)
to
occur?
7.4. Were
the
observations
and
measurements
based
on
standard,
valid,
and
reliable
data
collection
instruments/tests/procedures?
7.5. Was
the
measurement
of
effect
at
an
appropriate
level
of
precision?
7.6. Were
other
factors
accounted
for
(measured)
that
could
affect
outcomes?
7.7. Were
the
measurements
conducted
consistently
across
groups?
5.4
N/A
5.5
N/A
Yes
6.1
Yes
6.2
N/A
6.3
No
6.4
Yes
6.5
Yes
6.6
No
6.7
Yes
6.8
N/A
Yes
7.1
Yes
7.2
Yes
7.3
No
7.4
Yes
7.5
Yes
7.6
No
7.7
Yes
Yes
8.1
Yes
8.2
Yes
8.3
Yes
8.4
No
8.5
No
8.6
Yes
8.7
N/A
Yes
Yes
Yes
Yes
8. Was
the
statistical
analysis
appropriate
for
the
study
design
and
type
of
outcome
indicators?
8.1. Were
statistical
analyses
adequately
described
the
results
reported
appropriately?
8.2. Were
correct
statistical
tests
used
and
assumptions
of
test
not
violated?
8.3. Were
statistics
reported
with
levels
of
significance
and/or
confidence
intervals?
8.4. Was
intent
to
treat
analysis
of
outcomes
done
(and
as
appropriate,
was
there
an
analysis
of
outcomes
for
those
maximally
exposed
or
a
dose-response
analysis)?
8.5. Were
adequate
adjustments
made
for
effects
of
confounding
factors
that
might
have
affected
the
outcomes
(e.g.,
multivariate
analyses)?
8.6. Was
clinical
significance
as
well
as
statistical
significance
reported?
8.7. If
negative
findings,
was
a
power
calculation
reported
to
address
type
2
error?
9. Are
conclusions
supported
by
results
with
biases
and
limitations
taken
into
consideration?
9.1. Is
there
a
discussion
of
findings?
9.2. Are
biases
and
study
limitations
identified
and
discussed?
10. Is
bias
due
to
studys
funding
or
sponsorship
unlikely?
9.1
9.2
10
No
10.2
Yes
10.1
MINUS/NEGATIVE
(-)
If
most
(six
or
more)
of
the
answers
to
the
above
validity
questions
are
No,
the
report
should
be
designated
with
a
minus
(-)
symbol
on
the
Evidence
Worksheet.
NEUTRAL
()
If
the
answers
to
validity
criteria
questions
2,
3,
6,
and
7
do
not
indicate
that
the
study
is
exceptionally
strong,
the
report
should
be
designated
with
a
neutral
()
symbol
on
the
Evidence
Worksheet.
PLUS/POSITIVE
(+)
If
most
of
the
answers
to
the
above
validity
questions
are
Yes
(including
criteria
2,
3,
6,
7
and
at
least
one
additional
Yes),
the
report
should
be
designated
with
a
plus
symbol
(+)
on
the
Evidence
Worksheet.
Jiang,
J.,
Qiu,
H.,
Zhao,
G.,
Zhou,
Y.,
Zhang,
Z.,
Zhang,
H.,
Xu,
W.
H.
(2012).
Dietary
Fiber
Intake
Is
Associated
with
HbA1c
Level
among
Prevalent
Patients
with
Type
2
Diabetes
in
Pudong
New
Area
of
Shanghai,
China.
PLoS
ONE,
7(10).
http://doi.org/10.1371/journal.pone.0046552
(completed
by
Caitlyn
Edwards)
Study Design
Cross-sectional
Class
Quality
Rating
Research
Purpose
Inclusion
Criteria
Exclusion Criteria
+ (Positive)
- (Negative)
x (Neutral)
To
evaluate
the
association
of
dietary
factors
with
diabetic
control
status
among
Chinese
patienets
with
Type
2
Diabetes.
For
the
diabetes
group:
adults
diagnosed
with
Type
2
Diabetes
according
to
ADA
criteria.
For
the
group
without
diabetes:
adults
without
diseases
mentioned
in
Exclusion
Criteria.
For
both
groups:
Occurance
of
a
cardiovascular
event
during
the
previous
6
months,
advanced
congestive
heart
failure,
unstable
angina,
major
dpression
and
dementia.
Recruitment:
Diabetic
Participants
were
selected
from
the
Diabetes
Administration
Rosters,
and
the
non-diabetics
participants
were
spouses
and
friends
of
the
Diabetic
Participants.
Design:
Cross-sectional
Blinding
used
(if
applicable):
n/a
Description
of
Study
Protocol
Data
Collection
Summary
Ethnicity:
Chinese
Other
relevant
demographics:
Duration
of
Diabetes,
Medical
History
Questionnaires,
smoking
status
Anthropometrics:
Body
height,
Weight,
Waist
Circumference,
hip
circumference,
systolic
blood
pressure,
diastolic
blood
pressure,
BMI
Location:
Shanghai,
China
Key
Findings:
In
regards
to
fiber,
HbA1c
levels
were
negativley
correlated
with
dietary
fiber
intake,
and
regardless
of
duration
of
Type
2
Diabetes,
HbA1c
level
was
consistently
higher
in
patients
consuming
lower
levels
of
fiber.
Summary
of
Results
Other
Findings:
A
lower-average
level
of
HbA1c
related
with
higher
fiber
intake,
and
a
probably
protective
effect
of
dietary
fiber
on
glycemic
control
status.
Their
results
indicate
a
potential
role
of
dietary
fiber
in
glycemic
control,
but
still
Author
Conclusion
Reviewer
Comments
Funding
Source
need
to
be
confirmed.
A
very
well
done
cross-sectional.
It
would
have
been
interesting
to
see
HEI
along
with
these
fiber
variables.
Community
Health
Centers
in
Pudong
New
Area
of
Shanghia,
China
Explanation
Positive
Indicates
that
the
report
has
clearly
addressed
issues
of
inclusion/exclusion,
bias,
generalizability,
and
data
collection
and
analysis
Negative
Indicates
that
these
issues
have
not
been
adequately
addressed.
Neutral
indicates
that
the
report
is
neither
exceptionally
strong
nor
exceptionally
week
Select
a
rating
from
the
drop-down
menu
Relevance
Questions
1. Would
implementing
the
studied
intervention
or
procedure
(if
found
successful)
result
in
improved
outcomes
for
the
patients/clients/population
group?
(NA
for
some
Epi
studies)
2. Did
the
authors
study
an
outcome
(dependent
variable)
or
topic
that
the
patients/clients/population
group
would
care
about?
3. Is
the
focus
of
the
intervention
or
procedure
(independent
variable)
or
topic
of
study
a
common
issue
of
concern
to
dietetics
practice?
4. Is
the
intervention
or
procedure
feasible?
(NA
for
some
epidemiological
studies)
Yes
Yes
Yes
N/A
If
the
answers
to
all
of
the
above
relevance
questions
are
Yes,
the
report
is
eligible
for
designation
with
a
plus
(+)
on
the
Evidence
Quality
Worksheet,
depending
on
answers
to
the
following
validity
questions.
Validity
Questions
1. Was
the
research
question
clearly
stated?
Yes
1.2
Yes
Yes
1.3
Yes
Yes
2.1
Yes
2.2
Yes
2.3
Yes
2.4
Yes
N/A
3.1
N/A
3.2
N/A
3.3
Yes
3.4
N/A
3.5
N/A
3.6
N/A
Yes
4.1
Unclear
4.2
Yes
4.3
No
4.4
Unclear
4.5
N/A
N/A
5.1
N/A
5.2
No
5.3
N/A
5.4
N/A
5.5
N/A
N/A
6.1
N/A
1.1
4. Was
method
of
handling
withdrawals
described?
4.1. Were
follow
up
methods
described
and
the
same
for
all
groups?
4.2. Was
the
number,
characteristics
of
withdrawals
(i.e.,
dropouts,
lost
to
follow
up,
attrition
rate)
and/or
response
rate
(cross-sectional
studies)
described
for
each
group?
(Follow
up
goal
for
a
strong
study
is
80%.)
4.3. Were
all
enrolled
subjects/patients
(in
the
original
sample)
accounted
for?
4.4. Were
reasons
for
withdrawals
similar
across
groups
4.5. If
diagnostic
test,
was
decision
to
perform
reference
test
not
dependent
on
results
of
test
under
study?
5. Was
blinding
used
to
prevent
introduction
of
bias?
5.1. In
intervention
study,
were
subjects,
clinicians/practitioners,
and
investigators
blinded
to
treatment
group,
as
appropriate?
5.2. Were
data
collectors
blinded
for
outcomes
assessment?
(If
outcome
is
measured
using
an
objective
test,
such
as
a
lab
value,
this
criterion
is
assumed
to
be
met.)
5.3. In
cohort
study
or
cross-sectional
study,
were
measurements
of
outcomes
and
risk
factors
blinded?
5.4. In
case
control
study,
was
case
definition
explicit
and
case
ascertainment
not
influenced
by
exposure
status?
5.5. In
diagnostic
study,
were
test
results
blinded
to
patient
history
and
other
test
results?
6. Were
intervention/therapeutic
regimens/exposure
factor
or
procedure
and
any
comparison(s)
described
in
detail?
Were
intervening
factors
described?
6.1. In
RCT
or
other
intervention
trial,
were
protocols
described
for
all
regimens
studied?
6.2. In
observational
study,
were
interventions,
study
settings,
and
clinicians/provider
described?
6.3. Was
the
intensity
and
duration
of
the
intervention
or
exposure
factor
sufficient
to
produce
a
meaningful
effect?
6.4. Was
the
amount
of
exposure
and,
if
relevant,
subject/patient
compliance
measured?
6.5. Were
co-interventions
(e.g.,
ancillary
treatments,
other
therapies)
described?
6.6. Were
extra
or
unplanned
treatments
described?
6.7. Was
the
information
for
6.4,
6.5,
and
6.6
assessed
the
same
way
for
all
groups?
6.8. In
diagnostic
study,
were
details
of
test
administration
and
replication
sufficient?
7. Were
outcomes
clearly
defined
and
the
measurements
valid
and
reliable?
7.1. Were
primary
and
secondary
endpoints
described
and
relevant
to
the
question?
7.2. Were
nutrition
measures
appropriate
to
question
and
outcomes
of
concern?
7.3. Was
the
period
of
follow-up
long
enough
for
important
outcome(s)
to
occur?
7.4. Were
the
observations
and
measurements
based
on
standard,
valid,
and
reliable
data
collection
instruments/tests/procedures?
7.5. Was
the
measurement
of
effect
at
an
appropriate
level
of
precision?
7.6. Were
other
factors
accounted
for
(measured)
that
could
affect
outcomes?
7.7. Were
the
measurements
conducted
consistently
across
groups?
6.2
N/A
6.3
N/A
6.4
N/A
6.5
Yes
6.6
N/A
6.7
Yes
6.8
N/A
Yes
7.1
Yes
7.2
Yes
7.3
N/A
7.4
Yes
7.5
Yes
7.6
Yes
7.7
Yes
Yes
8.1
Yes
8.2
Yes
8.3
Yes
8.4
N/A
8.5
Yes
8.6
No
8.7
N/A
8. Was
the
statistical
analysis
appropriate
for
the
study
design
and
type
of
outcome
indicators?
8.1. Were
statistical
analyses
adequately
described
the
results
reported
appropriately?
8.2. Were
correct
statistical
tests
used
and
assumptions
of
test
not
violated?
8.3. Were
statistics
reported
with
levels
of
significance
and/or
confidence
intervals?
8.4. Was
intent
to
treat
analysis
of
outcomes
done
(and
as
appropriate,
was
there
an
analysis
of
outcomes
for
those
maximally
exposed
or
a
dose-response
analysis)?
8.5. Were
adequate
adjustments
made
for
effects
of
confounding
factors
that
might
have
affected
the
outcomes
(e.g.,
multivariate
analyses)?
8.6. Was
clinical
significance
as
well
as
statistical
significance
reported?
8.7. If
negative
findings,
was
a
power
calculation
reported
to
address
type
2
error?
9. Are
conclusions
supported
by
results
with
biases
and
limitations
taken
into
consideration?
9.1. Is
there
a
discussion
of
findings?
9.2. Are
biases
and
study
limitations
identified
and
discussed?
10. Is
bias
due
to
studys
funding
or
sponsorship
unlikely?
10.1. Were
sources
of
funding
and
investigators
affiliations
described?
10.2. Was
there
no
apparent
conflict
of
interest?
Yes
Yes
9.2
Yes
10
Yes
10.1
No
10.2
Yes
9
9.1
MINUS/NEGATIVE
(-)
If
most
(six
or
more)
of
the
answers
to
the
above
validity
questions
are
No,
the
report
should
be
designated
with
a
minus
(-)
symbol
on
the
Evidence
Worksheet.
NEUTRAL
()
If
the
answers
to
validity
criteria
questions
2,
3,
6,
and
7
do
not
indicate
that
the
study
is
exceptionally
strong,
the
report
should
be
designated
with
a
neutral
()
symbol
on
the
Evidence
Worksheet.
PLUS/POSITIVE
(+)
If
most
of
the
answers
to
the
above
validity
questions
are
Yes
(including
criteria
2,
3,
6,
7
and
at
least
one
additional
Yes),
the
report
should
be
designated
with
a
plus
symbol
(+)
on
the
Evidence
Worksheet.
Academy(of(Nutrition(and(Dietetics(
Evidence(Analysis(Library(Worksheet(Template(and(
Quality(Criteria(Checklist:(Primary(Research(
Citation'
Manisha'Chanalia',M.D.,Abhimanyu'Garg,M.D.,'Dieter'Lutjhonatann,PH.D.,'Klaus'
von'BErgmann,M.D.,'Scott'M.Grundy,M.D.,Ph.d.,and'Linda'J.'Brinkley,'R.'D.'
(2015).'Beneficial'Effects'of'High'Dietary'Fiber'Intake'in'Patients'With'Type'2'
Diabetes'Mellitus.'(completed'by'Grace'Kim)'
Study'Design'
Randomized'Crossover'Study'
Class'
A'
Quality'Rating'
Research'Purpose'
Inclusion'Criteria'
Exclusion'Criteria'
'+'(Positive)'''
'U'(Negative)''
'!'(Neutral)'
To'determine'the'effects'on'glycemic'control'and'plasma'lipid'concentrations'of'
increasing'the'intake'of'dietary'fiber'in'patients'with'type'2'diabetes'exclusivley'
through'the'conusmption'of'foods'not'fortified'with'fiber'to'a'level'beyond'that'
recommended'by'the'ADA'
insidious'onset'of'Type'2'diabetes;'developed'in'most'of'the'patients'after'40'
years'of'age'
N/A'
Recruitment:''general'clinical'research'center'of'University'of'Texas'Southwestern'
Medical'Center;'protocal'approved'by'IRB,'each'patient'gave'written'informed'
consent'
Design:''3'patients'treated'with'diet,'other'10'patients'treated'w/'2.5'to'20'mg'of'
glyburide'daily'in'addition'to'diet;'6'received'highUfiber'and'other'7'received'ADA'
Description'of'
Study'Protocol'
diet'first;'median'interval'of'seven'days,'then'received'other'diet'
Blinding'used'(if'applicable):''N/A'
Intervention'(if'applicable):''HighUfiber'diet'containing'50g'total'fiber'(25g'soluble,'
25g'insoluble)'vs.ADA'diet'containing'24g'of'total'fiber'(8g'soluble,'16g'insoluble)'
Statistical'Analysis:''repeatedUmeasures'analysis'of'variance'to'compare'two'study'
periods/assess'effect'of'sequence'in'which'patients'received'highUfiber'and'ADA;'
Wilcoxon'signedUrank'test'to'compare'two'dietary'periods'for'skewed'data.'
Detailed'history,'physical'examination,'laboratory'tests'were'performed,'
hospitialized'for'evaluation,'interviewed,'blood'for'lipid'analyses'were'drawn,'and'
fecal'samples'were'collected,'urine'specimens'
Timing'of'Measurements:'baseUline,'last'week'of'each'dietary'period'(dietary'
Data'Collection'
Summary'
period'lasts'for'6'weeks)'
Dependent'Variables:''measures'(blood'for'lipid'analyses,'plasma'glucose,'
glycosylated'hemoglobin'levels,'insulin'level,'fecal'sterol'balance,'cholesterol'
absorption)'
Independent'Variables:''highUfiber'diet'(50'g'total'fiber:'25g'soluble,'25g'
insoluble)'
Control'Variables:'ADA'diet;'(24'g'of'total'fiber:'8g'soluble,'16g'insoluble)'
Initial:''13'(6'intervention,'7'control;'after'six'weeks,'switched)''(12'Males'''1'
Females)'
Attrition'(final'N):''13'
Age:''61'9'years'(45U70)'
Ethnicity:''9'nonUHispanic'whites/4'blacks'
Description'of'
Other'relevant'demographics:''3'patients'treated'with'diet'alone,'other'10'
Actual'Data'Sample'
treated'with'2.5'to'20'mg'of'glyburide'daily'in'addition'to'diet'and'dose'was'not'
changed'during'the'study'
Anthropometrics:''mean'body'weight:93.5'12.7'kg;'mean'body'mass'index:'32.3'
3.9''
Location:''Dallas,'USA'
Key'Findings:'Mean'and'daily'plasma'glucose'concentration,'plasma'insulin'
concentrations,'and'glycosylated'hemoglobin'values'were'lower'after'highUfiber'
diet'completion'
'
Summary'of'Results' Other'Findings:'fasting'plasma'total'cholesterol'concentration,'plasma'triglyceride'
concentration,'lower'plasma'VLDL'cholesterol'concentration,'fasting'plasma'LDL'
cholesterol'concentration,'and'gastrointestinal'absorption'of'cholesterol'were'
lower'after'highUfiber'diet'completion;'sequence'of'diets'had'no'effect'on'the'
results'
HighUfiber'diet'improved'glycemic'control,'lowered'glycosylated'hemoglobin'
values;'specifically,'increase'in'intake'of'total'dietary'fiber'which'consists'
Author'Conclusion'
predominantly'of'soluble'fiber,'significantly'improved'glycemic'control'and'
decreased'degree'of'hyperinsulinemia'in'patients'with'type'2'diabetes'
This%study%was%able%to%conclude%that%fiber%has%an%effect%on%glycemic%control%in%
patients%with%type%2%diabetes;%however,%there%was%also%glyburide,%an%oral%diabetes%
Reviewer'
Comments'
medicine%that%helps%control%blood%sugar%levels,%given%to%only%10%of%the%patients.%It%
would%have%been%better%to%treat%all%the%patients%with%glyburide%for%more%
consistency.%%
National'Institutes'of'Health'grants'M01URR00633'&'HLU29252;'research'grants:'
Funding'Source'
Bundesministerium'fur'Bildung,'Forschung,'Wissenschaft'und'Technologie'
(01EC9402)'and'Deutsche'Forschungsgemeinschaft'(BE'1673/1U1)'
'
Quality(Criteria(Checklist:(Primary(Research(
Symbols(Used(
+(
77(
!(
Explanation(
Positive((Indicates'that'the'report'has'clearly'addressed'issues'of'inclusion/exclusion,'
bias,'generalizability,'and'data'collection'and'analysis(
Negative((Indicates'that'these'issues'have'not'been'adequately'addressed.(
Neutral('indicates'that'the'report'is'neither'exceptionally'strong'nor'exceptionally'
week(
Select'a'rating'from'the''
dropUdown'menu'!'
Relevance(Questions(
1.! Would'implementing'the'studied'intervention'or'procedure'(if'found'successful)'result'
in'improved'outcomes'for'the'patients/clients/population'group?'(NA'for'some'Epi'
studies)'
2.! Did'the'authors'study'an'outcome'(dependent'variable)'or'topic'that'the'
patients/clients/population'group'would'care'about?'
3.! Is'the'focus'of'the'intervention'or'procedure'(independent'variable)'or'topic'of'study'a'
common'issue'of'concern'to'dietetics'practice?'
4.! Is'the'intervention'or'procedure'feasible?'(NA'for'some'epidemiological'studies)'
1'
Yes'
2'
Yes'
3'
Yes'
4'
Yes'
If(the(answers(to(all(of(the(above(relevance(questions(are(Yes,(the(report(is(eligible(for(designation(with(a(
plus((+)(on(the(Evidence(Quality(Worksheet,(depending(on(answers(to(the(following(validity(questions.'
Validity(Questions'
1.! Was(the(research(question(clearly(stated?(
1.1.! Was'the'specific'intervention(s)'or'procedure'(independent'variable(s))'
identified?'
1.2.! Was'the'outcome(s)'(dependent'variable(s))'clearly'indicated?'
1.3.! Were'the'target'population'and'setting'specified?'
2.! Was(the(selection(of(study(subjects/patients(free(from(bias?(
2.1.! Were'inclusion/exclusion'criteria'specified'(e.g.,'risk,'point'in'disease'
progression,'diagnostic'or'prognosis'criteria),'and'with'sufficient'detail'and'
without'omitting'criteria'critical'to'the'study?'
2.2.! Were'criteria'applied'equally'to'all'study'groups?'
2.3.! Were'health,'demographics,'and'other'characteristics'of'subjects'described?'
2.4.! Were'the'subjects/patients'a'representative'sample'of'the'relevant'
population?'
3.! Were(study(groups(comparable?(
3.1.! Was'the'method'of'assigning'subjects/patients'to'groups'described'and'
unbiased?'(Method'of'randomization'identified'if'RCT)'
3.2.! Were'distribution'of'disease'status,'prognostic'factors,'and'other'factors'(e.g.,'
demographics)'similar'across'study'groups'at'baseline?'
3.3.! Were'concurrent'controls'used?'(Concurrent'preferred'over'historical'
controls.)'
3.4.! If'cohort'study'or'crossUsectional'study,'were'groups'comparable'on'important'
confounding'factors'and/or'were'preexisting'differences'accounted'for'by'using'
appropriate'adjustments'in'statistical'analysis?'
3.5.! If'case'control'study,'were'potential'confounding'factors'comparable'for'cases'
and'controls?'(If'case'series'or'trial'with'subjects'serving'as'own'control,'this'
criterion'is'not'applicable.'Criterion'may'not'be'applicable'in'some'crossU
sectional'studies.)'
3.6.! If'diagnostic'test,'was'there'an'independent'blind'comparison'with'an'
appropriate'reference'standard'(e.g.,'gold'standard)?'
'
1.3'
Yes'
Yes'
Yes'
No'
2'
Unclear'
2.1'
Unclear'
2.2'
Unclear'
2.3'
Yes'
2.4'
No'
3'
Yes'
3.1'
No'
3.2'
Unclear'
3.3'
Yes'
3.4'
Yes'
3.5'
N/A'
3.6'
N/A'
1'
1.1'
1.2'
'
4.! Was(method(of(handling(withdrawals(described?(
4.1.! Were'follow'up'methods'described'and'the'same'for'all'groups?(
4.2.! Was'the'number,'characteristics'of'withdrawals'(i.e.,'dropouts,'lost'to'follow'
up,'attrition'rate)'and/or'response'rate'(crossUsectional'studies)'described'for'
each'group?'(Follow'up'goal'for'a'strong'study'is'80%.)'
4.3.! Were'all'enrolled'subjects/patients'(in'the'original'sample)'accounted'for?'''
4.4.! Were'reasons'for'withdrawals'similar'across'groups'
4.5.! If'diagnostic'test,'was'decision'to'perform'reference'test'not'dependent'on'
results'of'test'under'study?'
5.! Was(blinding(used(to(prevent(introduction(of(bias?(
5.1.! In'intervention'study,'were'subjects,'clinicians/practitioners,'and'investigators'
blinded'to'treatment'group,'as'appropriate?(
5.2.! Were'data'collectors'blinded'for'outcomes'assessment?'(If'outcome'is'
measured''using'an'objective'test,'such'as'a'lab'value,'this'criterion'is'assumed'
to'be'met.)'
5.3.! In'cohort'study'or'crossUsectional'study,'were'measurements'of'outcomes'and'
risk''factors'blinded?''
5.4.! In'case'control'study,'was'case'definition'explicit'and'case'ascertainment'not'
influenced'by'exposure'status?'
5.5.! In'diagnostic'study,'were'test'results'blinded'to'patient'history'and'other'test'
results?'
6.! Were(intervention/therapeutic(regimens/exposure(factor(or(procedure(and(any(
comparison(s)(described(in(detail?(Were(intervening(factors(described?(
6.1.! In'RCT'or'other'intervention'trial,'were'protocols'described'for'all'regimens'
studied?'
6.2.! In'observational'study,'were'interventions,'study'settings,'and'
clinicians/provider'''described?'
6.3.! Was'the'intensity'and'duration'of'the'intervention'or'exposure'factor'sufficient'
to'produce'a'meaningful'effect?'
6.4.! Was'the'amount'of'exposure'and,'if'relevant,'subject/patient'compliance'
measured?'
6.5.! Were'coUinterventions'(e.g.,'ancillary'treatments,'other'therapies)'described?'
6.6.! Were'extra'or'unplanned'treatments'described?'
6.7.! Was'the'information'for'6.4,'6.5,'and'6.6'assessed'the'same'way'for'all'groups?'
6.8.! In'diagnostic'study,'were'details'of'test'administration'and'replication'
sufficient?'
7.! Were(outcomes(clearly(defined(and(the(measurements(valid(and(reliable?(
7.1.! Were'primary'and'secondary'endpoints'described'and'relevant'to'the'
question?'''
7.2.! Were'nutrition'measures'appropriate'to'question'and'outcomes'of'concern?'
7.3.! Was'the'period'of'followUup'long'enough'for'important'outcome(s)'to'occur?'
7.4.! Were'the'observations'and'measurements'based'on'standard,'valid,'and'
reliable'data'collection'instruments/tests/procedures?'
7.5.! Was'the'measurement'of'effect'at'an'appropriate'level'of'precision?'
7.6.! Were'other'factors'accounted'for'(measured)'that'could'affect'outcomes?'
7.7.! Were'the'measurements'conducted'consistently'across'groups?'
'
'
'
'
4'
Yes'
4.1'
Yes'
4.2'
No'
4.3'
Yes'
4.4'
N/A'
4.5'
N/A'
5'
No'
5.1'
N/A'
5.2'
N/A'
5.3'
No'
5.4'
N/A'
5.5'
N/A'
6'
Yes'
6.1'
Yes'
6.2'
N/A'
6.3'
Yes'
6.4'
Yes'
6.5'
Yes'
6.6'
Unclear'
6.7'
Yes'
6.8'
N/A'
7'
Yes'
7.1'
Yes'
7.2'
Yes'
7.3'
Unclear'
7.4'
Yes'
7.5'
Unclear'
7.6'
Yes'
7.7'
Unclear'
8.! Was(the(statistical(analysis(appropriate(for(the(study(design(and(type(of(outcome(
indicators?((
8.1.! Were'statistical'analyses'adequately'described'the'results'reported'
appropriately?'
8.2.! Were'correct'statistical'tests'used'and'assumptions'of'test'not'violated?'
8.3.! Were'statistics'reported'with'levels'of'significance'and/or'confidence'intervals?'
8.4.! Was'intent'to'treat'analysis'of'outcomes'done'(and'as'appropriate,'was'there'
an'analysis'of'outcomes'for'those'maximally'exposed'or'a'doseUresponse'
analysis)?'
8.5.! Were'adequate'adjustments'made'for'effects'of'confounding'factors'that'
might'have'affected'the'outcomes'(e.g.,'multivariate'analyses)?'
8.6.! Was'clinical'significance'as'well'as'statistical'significance'reported?'
8.7.! If'negative'findings,'was'a'power'calculation'reported'to'address'type'2'error?'
9.! Are(conclusions(supported(by(results(with(biases(and(limitations(taken(into(
consideration?'
9.1.! Is'there'a'discussion'of'findings?'
9.2.! Are'biases'and'study'limitations'identified'and'discussed?'
10.! Is(bias(due(to(studys(funding(or(sponsorship(unlikely?(
10.1.!Were'sources'of'funding'and'investigators'affiliations'described?'
10.2.!Was'there'no'apparent'conflict'of'interest?'
8'
Yes'
8.1'
Yes'
8.2'
Yes'
8.3'
Yes'
8.4'
N/A'
8.5'
Yes'
8.6'
Yes'
8.7'
N/A'
N/A'
9.1'
No'
9.2'
Unclear'
10'
N/A'
10.1' Yes'
10.2' Yes'
9'
MINUS/NEGATIVE((7)(
If%most%(six%or%more)%of%the%answers%to%the%above%validity%questions%are%No,%the%report%should%be%designated%with%a%minus%%
(F)%symbol%on%the%Evidence%Worksheet.'
NEUTRAL((!)%
If%the%answers%to%validity%criteria%questions%2,%3,%6,%and%7%do%not%indicate%that%the%study%is%exceptionally%strong,%the%report%
should%be%designated%with%a%neutral%(!)'symbol%on%the%Evidence%Worksheet.'
PLUS/POSITIVE((+)%
If%most%of%the%answers%to%the%above%validity%questions%are%Yes%(including%criteria%2,%3,%6,%7%and%at%least%one%additional%
Yes),%the%report%should%be%designated%with%a%plus%symbol%(+)%on%the%Evidence%Worksheet.'
'
Academy(of(Nutrition(and(Dietetics(
Evidence(Analysis(Library(Worksheet(Template(and(
Quality(Criteria(Checklist:(Primary(Research(
Citation'
Reviewer:'Ria'Thakur'
'
Lubia'Velzquez9Lpez,'Abril'Violeta'Muoz9Torres,'Carmen'Garca9Pea,'Mardia'
Lpez9Alarcn,'Sergio'Islas9Andrade,'and'Jorge'Escobedo9de'la'Pea,'Fiber'in'Diet'
Is'Associated'with'Improvement'of'Glycated'Hemoglobin'and'Lipid'Profile'in'
Mexican'Patients'with'Type'2'Diabetes,'Journal'of'Diabetes'Research,'vol.'2016,'
Article'ID'2980406,'9'pages,'2016.'doi:10.1155/2016/2980406'
Study'Design'
Cross'Sectional'Study'
Class'
D'
Quality'Rating'
Research'Purpose'
Inclusion'Criteria'
Exclusion'Criteria'
'+'(Positive)'''
'9'(Negative)''
'!'(Neutral)'
Assess'the'association'of'dietary'fiber'on'current'everyday'diet'and'other'dietary'
components'in'patients'with'Type'2'Diabetes.'
Patients'with'Type'2'Diabetes,'patients'from'4'different'primary'care'clinics'in'
Mexico'City'with'a'previous'diagnosis'of'diabetes,'<70'yrs'old,'no'advanced'
microvascular'complication.'
Patients'who'didnt'have'diabetes,'who'werent'a'part'of'the'clinical'trial,'>70'yrs'
old'
Recruitment:'''''''''''''Participants'from'the'randomized'clinical'trial'called'Efficacy'
of'Nutritional'Therapy'and'Education'through'a'Multimedia'System'for'the'
Metabolic'Control'of'Type'2'Diabetes'Patients'were'invited'to'participate'at'theur'
local'clinic'and'incorporated'into'the'study'once'they'had'signed'the'letter'of'
informed'consent.'
Description'of'
Study'Protocol'
Design:''dPatients'in'the'study'went'through'intensive'medical'history'
questionnaire'as'well'as'physical'examination.'
Blinding'used'(if'applicable):''None'
Intervention'(if'applicable):''Twelve9hour9fasting'blood'plasma,'glucose'
concentration,'creatinine,'triglycerides,'total'cholesterol,'and'fractions'HDL9c'
values'were'measured'
Statistical'Analysis:''Friedewald'equation,'
high9resolution'liquid'chromatography'method,'photometry/nephelometry,'
Habitch'method,'TANITA'body'composition'analyzer,'food'frequency'
questionnaire,'System'to'calculate'nutritional'vectors,'Kruskal9Wallis'test,'chi9
Data'Collection'
Summary'
minutes.Physical'activity'was'considered'when'the'patient'had'at'least'
150min/week'of'moderate9intensity'aerobic'physical'activity,'for'at'least'3'
days/week'with'no'more'than'2'consecutive'days'without'exercise''
Dependent'Variables:''change'in'hbA1c,'triglyceride'levels,'HDL9c'levels,',''
Independent'Variables:''Diabetes'education,'appropriate'meal'plan'and'physical'
activity,'anthropometric'measures,''
Control'Variables:'Specific'nutrient'intake'
Initial:''395''(not'specifiec'Males'''not'specified'Females)'
Attrition'(final'N):''395'
Age:''<70years'old''
Ethnicity:''Mexicans'
Description'of'
Other'relevant'demographics:''Part'of'a'multicenter,'randomized'clinical'trial'
Actual'Data'Sample'
called'Efficacy'of'Nutritional'Therapy'and'Education'through'a'Multimedia'System'
for'the'Metabolic'Control'of'Type'2'Diabetes'Patients''
Anthropometrics:''88%'of'participants'had'BMI'>'normal.'
Location:''Mexico'City'
Key'Findings:'A'higher'content'of''fiber'in'the'diet'had'an'impact'on'reducing'
HbA1c'and'triglyceride'levels,'while'improving'HDL9c'levels.''
'
Other'Findings:''55%had'hypertension,'26%'had'diabetic'neuropathy,'12%'had'
Summary'of'Results' microalbuminuria,'and'5%'had'macroalbuminuria,'only'12%'had'BMI'in'a'normal'
range,''Only'34%'had'a'desirable'HbA1c;'total'cholesterol'was'within'control'
range'for'over'50%'of'the'population,'whereas'triglycerides,'LDL9c,'and'HDL9c'
were'found'to'be'within'normal'range'in'only'third'of'the'subjects.'
'
There'is'statistical'significance'that'shows'that'a'high'fiber'diet'lowers'HbA1c'and'
Author'Conclusion'
Reviewer'
Comments'
triglyceride'levels'while'improving'HDL9c'levels.''
I"wish"there"was"a"specific"diet"intervention"performed"in"this"study."Also,"I"wish"
the"kind"of"fiber"was"specified"if"it"was"soluble"or"insoluble.""
Mexico'National'Science'and'Technology'Council'(Consejo'Nacional'de'Ciencia'y'
Funding'Source'
Tecnologa,'CONACYT)'no.'SALUD920129019181015'
'
Quality(Criteria(Checklist:(Primary(Research(
Symbols(Used(
+(
Explanation(
Positive((Indicates'that'the'report'has'clearly'addressed'issues'of'inclusion/exclusion,'
77(
!(
bias,'generalizability,'and'data'collection'and'analysis(
Negative((Indicates'that'these'issues'have'not'been'adequately'addressed.(
Neutral('indicates'that'the'report'is'neither'exceptionally'strong'nor'exceptionally'
week(
Select'a'rating'from'the''
drop9down'menu'!'
Relevance(Questions(
1.! Would'implementing'the'studied'intervention'or'procedure'(if'found'successful)'result'
in'improved'outcomes'for'the'patients/clients/population'group?'(NA'for'some'Epi'
studies)'
2.! Did'the'authors'study'an'outcome'(dependent'variable)'or'topic'that'the'
patients/clients/population'group'would'care'about?'
3.! Is'the'focus'of'the'intervention'or'procedure'(independent'variable)'or'topic'of'study'a'
common'issue'of'concern'to'dietetics'practice?'
4.! Is'the'intervention'or'procedure'feasible?'(NA'for'some'epidemiological'studies)'
1'
Yes'
2'
Yes'
3'
Yes'
4'
Yes'
If(the(answers(to(all(of(the(above(relevance(questions(are(Yes,(the(report(is(eligible(for(designation(with(a(
plus((+)(on(the(Evidence(Quality(Worksheet,(depending(on(answers(to(the(following(validity(questions.'
Validity(Questions'
1.! Was(the(research(question(clearly(stated?(
1.1.! Was'the'specific'intervention(s)'or'procedure'(independent'variable(s))'
identified?'
1.2.! Was'the'outcome(s)'(dependent'variable(s))'clearly'indicated?'
1.3.! Were'the'target'population'and'setting'specified?'
2.! Was(the(selection(of(study(subjects/patients(free(from(bias?(
2.1.! Were'inclusion/exclusion'criteria'specified'(e.g.,'risk,'point'in'disease'
progression,'diagnostic'or'prognosis'criteria),'and'with'sufficient'detail'and'
without'omitting'criteria'critical'to'the'study?'
2.2.! Were'criteria'applied'equally'to'all'study'groups?'
2.3.! Were'health,'demographics,'and'other'characteristics'of'subjects'described?'
2.4.! Were'the'subjects/patients'a'representative'sample'of'the'relevant'
population?'
3.! Were(study(groups(comparable?(
3.1.! Was'the'method'of'assigning'subjects/patients'to'groups'described'and'
unbiased?'(Method'of'randomization'identified'if'RCT)'
3.2.! Were'distribution'of'disease'status,'prognostic'factors,'and'other'factors'(e.g.,'
demographics)'similar'across'study'groups'at'baseline?'
3.3.! Were'concurrent'controls'used?'(Concurrent'preferred'over'historical'
controls.)'
3.4.! If'cohort'study'or'cross9sectional'study,'were'groups'comparable'on'important'
confounding'factors'and/or'were'preexisting'differences'accounted'for'by'using'
appropriate'adjustments'in'statistical'analysis?'
3.5.! If'case'control'study,'were'potential'confounding'factors'comparable'for'cases'
and'controls?'(If'case'series'or'trial'with'subjects'serving'as'own'control,'this'
criterion'is'not'applicable.'Criterion'may'not'be'applicable'in'some'cross9
sectional'studies.)'
3.6.! If'diagnostic'test,'was'there'an'independent'blind'comparison'with'an'
appropriate'reference'standard'(e.g.,'gold'standard)?'
1.3'
Yes'
Yes'
Yes'
Yes'
2'
Unclear'
2.1'
No'
2.2'
N/A'
2.3'
Yes'
2.4'
No'
3'
No'
3.1'
Unclear'
3.2'
Yes'
3.3'
Unclear'
3.4'
Yes'
3.5'
N/A'
3.6'
N/A'
4'
No'
1'
1.1'
1.2'
'
'
4.! Was(method(of(handling(withdrawals(described?(
4.1.! Were'follow'up'methods'described'and'the'same'for'all'groups?(
4.2.! Was'the'number,'characteristics'of'withdrawals'(i.e.,'dropouts,'lost'to'follow'
up,'attrition'rate)'and/or'response'rate'(cross9sectional'studies)'described'for'
each'group?'(Follow'up'goal'for'a'strong'study'is'80%.)'
4.3.! Were'all'enrolled'subjects/patients'(in'the'original'sample)'accounted'for?'''
4.4.! Were'reasons'for'withdrawals'similar'across'groups'
4.5.! If'diagnostic'test,'was'decision'to'perform'reference'test'not'dependent'on'
results'of'test'under'study?'
5.! Was(blinding(used(to(prevent(introduction(of(bias?(
5.1.! In'intervention'study,'were'subjects,'clinicians/practitioners,'and'investigators'
blinded'to'treatment'group,'as'appropriate?(
5.2.! Were'data'collectors'blinded'for'outcomes'assessment?'(If'outcome'is'
measured''using'an'objective'test,'such'as'a'lab'value,'this'criterion'is'assumed'
to'be'met.)'
5.3.! In'cohort'study'or'cross9sectional'study,'were'measurements'of'outcomes'and'
risk''factors'blinded?''
5.4.! In'case'control'study,'was'case'definition'explicit'and'case'ascertainment'not'
influenced'by'exposure'status?'
5.5.! In'diagnostic'study,'were'test'results'blinded'to'patient'history'and'other'test'
results?'
6.! Were(intervention/therapeutic(regimens/exposure(factor(or(procedure(and(any(
comparison(s)(described(in(detail?(Were(intervening(factors(described?(
6.1.! In'RCT'or'other'intervention'trial,'were'protocols'described'for'all'regimens'
studied?'
6.2.! In'observational'study,'were'interventions,'study'settings,'and'
clinicians/provider'''described?'
6.3.! Was'the'intensity'and'duration'of'the'intervention'or'exposure'factor'sufficient'
to'produce'a'meaningful'effect?'
6.4.! Was'the'amount'of'exposure'and,'if'relevant,'subject/patient'compliance'
measured?'
6.5.! Were'co9interventions'(e.g.,'ancillary'treatments,'other'therapies)'described?'
6.6.! Were'extra'or'unplanned'treatments'described?'
6.7.! Was'the'information'for'6.4,'6.5,'and'6.6'assessed'the'same'way'for'all'groups?'
6.8.! In'diagnostic'study,'were'details'of'test'administration'and'replication'
sufficient?'
7.! Were(outcomes(clearly(defined(and(the(measurements(valid(and(reliable?(
7.1.! Were'primary'and'secondary'endpoints'described'and'relevant'to'the'
question?'''
7.2.! Were'nutrition'measures'appropriate'to'question'and'outcomes'of'concern?'
7.3.! Was'the'period'of'follow9up'long'enough'for'important'outcome(s)'to'occur?'
7.4.! Were'the'observations'and'measurements'based'on'standard,'valid,'and'
reliable'data'collection'instruments/tests/procedures?'
7.5.! Was'the'measurement'of'effect'at'an'appropriate'level'of'precision?'
7.6.! Were'other'factors'accounted'for'(measured)'that'could'affect'outcomes?'
7.7.! Were'the'measurements'conducted'consistently'across'groups?'
4.1'
N/A'
4.2'
No'
4.3'
Unclear'
4.4'
N/A'
4.5'
N/A'
5'
Unclear'
5.1'
N/A'
5.2'
No'
5.3'
No'
5.4'
N/A'
5.5'
N/A'
6'
Yes'
6.1'
Yes'
6.2'
N/A'
6.3'
N/A'
6.4'
Unclear'
6.5'
N/A'
6.6'
Unclear'
6.7'
Unclear'
6.8'
N/A'
7'
Yes'
7.1'
Yes'
7.2'
Yes'
7.3'
Unclear'
7.4'
Yes'
7.5'
Yes'
7.6'
Yes'
7.7'
Yes'
8'
Yes'
8.1'
Yes'
'
'
'
'
8.! Was(the(statistical(analysis(appropriate(for(the(study(design(and(type(of(outcome(
indicators?((
8.1.! Were'statistical'analyses'adequately'described'the'results'reported'
appropriately?'
8.2.! Were'correct'statistical'tests'used'and'assumptions'of'test'not'violated?'
8.3.! Were'statistics'reported'with'levels'of'significance'and/or'confidence'intervals?'
8.4.! Was'intent'to'treat'analysis'of'outcomes'done'(and'as'appropriate,'was'there'
an'analysis'of'outcomes'for'those'maximally'exposed'or'a'dose9response'
analysis)?'
8.5.! Were'adequate'adjustments'made'for'effects'of'confounding'factors'that'
might'have'affected'the'outcomes'(e.g.,'multivariate'analyses)?'
8.6.! Was'clinical'significance'as'well'as'statistical'significance'reported?'
8.7.! If'negative'findings,'was'a'power'calculation'reported'to'address'type'2'error?'
9.! Are(conclusions(supported(by(results(with(biases(and(limitations(taken(into(
consideration?'
9.1.! Is'there'a'discussion'of'findings?'
9.2.! Are'biases'and'study'limitations'identified'and'discussed?'
10.! Is(bias(due(to(studys(funding(or(sponsorship(unlikely?(
10.1.!Were'sources'of'funding'and'investigators'affiliations'described?'
10.2.!Was'there'no'apparent'conflict'of'interest?'
8.2'
Yes'
8.3'
Yes'
8.4'
No'
8.5'
Yes'
8.6'
Yes'
8.7'
Yes'
Yes'
Yes'
9.2'
Yes'
10'
Yes'
10.1' Yes'
10.2' Yes'
9'
9.1'
MINUS/NEGATIVE((7)(
If"most"(six"or"more)"of"the"answers"to"the"above"validity"questions"are"No,"the"report"should"be"designated"with"a"minus""
(C)"symbol"on"the"Evidence"Worksheet.'
NEUTRAL((!)"
If"the"answers"to"validity"criteria"questions"2,"3,"6,"and"7"do"not"indicate"that"the"study"is"exceptionally"strong,"the"report"
should"be"designated"with"a"neutral"(!)'symbol"on"the"Evidence"Worksheet.'
PLUS/POSITIVE((+)"
If"most"of"the"answers"to"the"above"validity"questions"are"Yes"(including"criteria"2,"3,"6,"7"and"at"least"one"additional"
Yes),"the"report"should"be"designated"with"a"plus"symbol"(+)"on"the"Evidence"Worksheet.'
'
Academy(of(Nutrition(and(Dietetics(
Evidence(Analysis(Library(Worksheet(Template(and(
Quality(Criteria(Checklist:(Primary(Research(
Citation'
Reviewed'by:'Jessica'Park'
Chen,'C.,'Zeng,'Y.,'Xu,'J.,'Zheng,'H.,'Liu,'J.,'Fan,'R.,''Wang,'J.'(2016).'Therapeutic'
effects'of'soluble'dietary'fiber'consumption'on'type'2'diabetes'mellitus.'
Experimental'and'Therapeutic'Medicine,'12(2),'12321242.'
http://doi.org/10.3892/etm.2016.3377'
Study'Design'
Randomized'controlled'experiment'
Class'
A'
Quality'Rating'
Research'Purpose'
Inclusion'Criteria'
Exclusion'Criteria'
'+'(Positive)'''
'^'(Negative)''
'!'(Neutral)'
To'investigate'the'effects'of'fiber'on'glycemic'control'and'plasma'lipid'
concentrations'in'patients'with'type'2'diabetes'
diagnosed'with'type'2'diabetes'for'6'months'or'more,'patient'at'Xinqiao'Hospital'
of'the'Third'Military'Medical'University,'no'tumors,'no'myocardial'infarction,'no'
unstable'angina'pectoris'and'congestive'heart'failure'
tumors,'myocardial'infarction,'unstable'angina'pectoris,'congestive'heart'failure,'
thyroid'or'hepatic'disease,'lipid^lowering'treatments,'not'diagnosed'with'DM2'
Recruitment:''Subjects'that'met'criteria'were'randomly'selected'from'the'
Xinquiao'Hospital'of'Third'Military'Medical'University'and'divided'into'3'groups'
(control,'low^dose'(10g),'and'high^dose'(20g)'
Design:''Randomized'controlled'experiment.'40'patients'treated'with'ADA'diet'
Description'of'
Study'Protocol'
alone,'remaining'80'patients'treated'with'10'or'20'mg'soluble'fiber'daily'in'
addition'to'the'ADA'diet'for'one'month.'All'patients'received'MNT'
Blinding'used'(if'applicable):''double^blind'
Intervention'(if'applicable):''soluble'fiber'(10g'or'20g)'
Statistical'Analysis:'''Data'analyzed'using'SPSS'software'version'19.0,'95%'CIs,'
Shapiro^Wilk'test'for'normal'distribution,'t^test'
Patients'were'required'to'recount'the'remaining'soluble'fiber'during'phone'
consultation'every'week'
Timing'of'Measurements:'all'measurements'taken'prior'to'and'following'
treatment'by'clinical'lab'techs'who'were'blinded'to'content'and'purpose'of'the'
Data'Collection'
Summary'
study'
Dependent'Variables:''results'of'blood'marker'analysis,'anthropometric'measures,'
lipid'profile,'and'assessment'of'physical'characteristics'pre^'and'post^treatment'
Independent'Variables:''amount'of'soluble'fiber'given'(g)'
Control'Variables:'no'soluble'fiber'given'
Description'of'
Initial:''120''(46'Males'''71'Females)'
Actual'Data'Sample'
Attrition'(final'N):''3'left'for'personal'reasons'from'control'group.'Final'N:'117'
Age:''45^70'
Ethnicity:''Chinese'
Other'relevant'demographics:''' ' ' ' ' '
Anthropometrics:''mean'body'weight:'68.113.0'kg'and'mean'BMI:'25.33.9'
kg/m2'
Location:''Chongquing,'China'
Key'Findings:'At'the'end'of'treatment,'systolic'pressure'and'levels'of'HDL,'LDL,'
and'apoB'were'significantly'improved'in'the'20mg'group'compared'with'data'
prior'to'treatment'(P<0.05).'Fasting'insulin,'2^h'blood'glucose'and'Lpa'levels,'and'
the'insulin'resistance'index'were'significantly'improved'in'all'3'groups'(P<0.05).'
Summary'of'Results' '
Other'Findings:'2^h'blood'glucose,'fasting'insulin,'and'insulin'resistance'index'
were'significantly'improved'from'baseline'in'all'three'groups,'suggesting'MNT'
treatment'had'significant'impact,'increased'fiber'intake'was'shown'to'improve'
insulin'sensitivity'and'reduce'systemic'inflammation'
MNT'was'able'to'improve'2^h'blood'glucose'and'fasting'insulin'levels,'and'the'
Author'Conclusion'
Reviewer'
Comments'
insulin'resistance'index,'and'was'effective'in'maintaining'glycemic'control'
!!!!!!
National'Science'and'Technology'Support'Program,'Chongqing'Science'and'
Technology'Commission,''the'11th'Five^year'Plan''for'the'National'Key'Technology'
Funding'Source'
Research'and'Development'Program,'and'the'Innovation'Project'of'Chongqing'
Key'Laboratory'of'Nutrition'and'Food'Safety'
'
Quality(Criteria(Checklist:(Primary(Research(
Symbols(Used(
+(
77(
!(
Explanation(
Positive((Indicates'that'the'report'has'clearly'addressed'issues'of'inclusion/exclusion,'
bias,'generalizability,'and'data'collection'and'analysis(
Negative((Indicates'that'these'issues'have'not'been'adequately'addressed.(
Neutral('indicates'that'the'report'is'neither'exceptionally'strong'nor'exceptionally'
week(
Select'a'rating'from'the''
drop^down'menu'!'
Relevance(Questions(
1.! Would'implementing'the'studied'intervention'or'procedure'(if'found'successful)'result'
in'improved'outcomes'for'the'patients/clients/population'group?'(NA'for'some'Epi'
studies)'
2.! Did'the'authors'study'an'outcome'(dependent'variable)'or'topic'that'the'
1'
Yes'
2'
Yes'
patients/clients/population'group'would'care'about?'
3.! Is'the'focus'of'the'intervention'or'procedure'(independent'variable)'or'topic'of'study'a'
common'issue'of'concern'to'dietetics'practice?'
4.! Is'the'intervention'or'procedure'feasible?'(NA'for'some'epidemiological'studies)'
3'
Yes'
4'
Yes'
If(the(answers(to(all(of(the(above(relevance(questions(are(Yes,(the(report(is(eligible(for(designation(with(a(
plus((+)(on(the(Evidence(Quality(Worksheet,(depending(on(answers(to(the(following(validity(questions.'
Validity(Questions'
1.! Was(the(research(question(clearly(stated?(
1.1.! Was'the'specific'intervention(s)'or'procedure'(independent'variable(s))'
identified?'
1.2.! Was'the'outcome(s)'(dependent'variable(s))'clearly'indicated?'
1.3.! Were'the'target'population'and'setting'specified?'
2.! Was(the(selection(of(study(subjects/patients(free(from(bias?(
2.1.! Were'inclusion/exclusion'criteria'specified'(e.g.,'risk,'point'in'disease'
progression,'diagnostic'or'prognosis'criteria),'and'with'sufficient'detail'and'
without'omitting'criteria'critical'to'the'study?'
2.2.! Were'criteria'applied'equally'to'all'study'groups?'
2.3.! Were'health,'demographics,'and'other'characteristics'of'subjects'described?'
2.4.! Were'the'subjects/patients'a'representative'sample'of'the'relevant'
population?'
3.! Were(study(groups(comparable?(
3.1.! Was'the'method'of'assigning'subjects/patients'to'groups'described'and'
unbiased?'(Method'of'randomization'identified'if'RCT)'
3.2.! Were'distribution'of'disease'status,'prognostic'factors,'and'other'factors'(e.g.,'
demographics)'similar'across'study'groups'at'baseline?'
3.3.! Were'concurrent'controls'used?'(Concurrent'preferred'over'historical'
controls.)'
3.4.! If'cohort'study'or'cross^sectional'study,'were'groups'comparable'on'important'
confounding'factors'and/or'were'preexisting'differences'accounted'for'by'using'
appropriate'adjustments'in'statistical'analysis?'
3.5.! If'case'control'study,'were'potential'confounding'factors'comparable'for'cases'
and'controls?'(If'case'series'or'trial'with'subjects'serving'as'own'control,'this'
criterion'is'not'applicable.'Criterion'may'not'be'applicable'in'some'cross^
sectional'studies.)'
3.6.! If'diagnostic'test,'was'there'an'independent'blind'comparison'with'an'
appropriate'reference'standard'(e.g.,'gold'standard)?'
1.3'
Yes'
Yes'
Yes'
Yes'
2'
Yes'
2.1'
Yes'
2.2'
Yes'
2.3'
Yes'
2.4'
Yes'
3'
Yes'
3.1'
Yes'
3.2'
Yes'
3.3'
Yes'
3.4'
N/A'
3.5'
Yes'
3.6'
N/A'
4'
Yes'
4.1'
Unclear'
4.2'
Yes'
4.3'
Yes'
4.4'
Yes'
4.5'
N/A'
5'
Yes'
5.1'
Yes'
5.2'
Yes'
1'
1.1'
1.2'
'
'
4.! Was(method(of(handling(withdrawals(described?(
4.1.! Were'follow'up'methods'described'and'the'same'for'all'groups?(
4.2.! Was'the'number,'characteristics'of'withdrawals'(i.e.,'dropouts,'lost'to'follow'
up,'attrition'rate)'and/or'response'rate'(cross^sectional'studies)'described'for'
each'group?'(Follow'up'goal'for'a'strong'study'is'80%.)'
4.3.! Were'all'enrolled'subjects/patients'(in'the'original'sample)'accounted'for?'''
4.4.! Were'reasons'for'withdrawals'similar'across'groups'
4.5.! If'diagnostic'test,'was'decision'to'perform'reference'test'not'dependent'on'
results'of'test'under'study?'
5.! Was(blinding(used(to(prevent(introduction(of(bias?(
5.1.! In'intervention'study,'were'subjects,'clinicians/practitioners,'and'investigators'
blinded'to'treatment'group,'as'appropriate?(
5.2.! Were'data'collectors'blinded'for'outcomes'assessment?'(If'outcome'is'
measured''using'an'objective'test,'such'as'a'lab'value,'this'criterion'is'assumed'
to'be'met.)'
5.3.! In'cohort'study'or'cross^sectional'study,'were'measurements'of'outcomes'and'
risk''factors'blinded?''
5.4.! In'case'control'study,'was'case'definition'explicit'and'case'ascertainment'not'
influenced'by'exposure'status?'
5.5.! In'diagnostic'study,'were'test'results'blinded'to'patient'history'and'other'test'
results?'
6.! Were(intervention/therapeutic(regimens/exposure(factor(or(procedure(and(any(
comparison(s)(described(in(detail?(Were(intervening(factors(described?(
6.1.! In'RCT'or'other'intervention'trial,'were'protocols'described'for'all'regimens'
studied?'
6.2.! In'observational'study,'were'interventions,'study'settings,'and'
clinicians/provider'''described?'
6.3.! Was'the'intensity'and'duration'of'the'intervention'or'exposure'factor'sufficient'
to'produce'a'meaningful'effect?'
6.4.! Was'the'amount'of'exposure'and,'if'relevant,'subject/patient'compliance'
measured?'
6.5.! Were'co^interventions'(e.g.,'ancillary'treatments,'other'therapies)'described?'
6.6.! Were'extra'or'unplanned'treatments'described?'
6.7.! Was'the'information'for'6.4,'6.5,'and'6.6'assessed'the'same'way'for'all'groups?'
6.8.! In'diagnostic'study,'were'details'of'test'administration'and'replication'
sufficient?'
7.! Were(outcomes(clearly(defined(and(the(measurements(valid(and(reliable?(
7.1.! Were'primary'and'secondary'endpoints'described'and'relevant'to'the'
question?'''
7.2.! Were'nutrition'measures'appropriate'to'question'and'outcomes'of'concern?'
7.3.! Was'the'period'of'follow^up'long'enough'for'important'outcome(s)'to'occur?'
7.4.! Were'the'observations'and'measurements'based'on'standard,'valid,'and'
reliable'data'collection'instruments/tests/procedures?'
7.5.! Was'the'measurement'of'effect'at'an'appropriate'level'of'precision?'
7.6.! Were'other'factors'accounted'for'(measured)'that'could'affect'outcomes?'
7.7.! Were'the'measurements'conducted'consistently'across'groups?'
5.3'
N/A'
5.4'
Yes'
5.5'
N/A'
6'
Yes'
6.1'
Yes'
6.2'
N/A'
6.3'
Yes'
6.4'
Yes'
6.5'
Yes'
6.6'
Unclear'
6.7'
Yes'
6.8'
N/A'
7'
Yes'
7.1'
Unclear'
7.2'
Yes'
7.3'
Yes'
7.4'
Yes'
7.5'
Yes'
7.6'
Unclear'
7.7'
Yes'
8'
Yes'
8.1'
Yes'
8.2'
Yes'
8.3'
Yes'
8.4'
Yes'
8.5'
Unclear'
8.6'
Yes'
8.7'
N/A'
9'
Yes'
Yes'
No'
'
'
'
'
8.! Was(the(statistical(analysis(appropriate(for(the(study(design(and(type(of(outcome(
indicators?((
8.1.! Were'statistical'analyses'adequately'described'the'results'reported'
appropriately?'
8.2.! Were'correct'statistical'tests'used'and'assumptions'of'test'not'violated?'
8.3.! Were'statistics'reported'with'levels'of'significance'and/or'confidence'intervals?'
8.4.! Was'intent'to'treat'analysis'of'outcomes'done'(and'as'appropriate,'was'there'
an'analysis'of'outcomes'for'those'maximally'exposed'or'a'dose^response'
analysis)?'
8.5.! Were'adequate'adjustments'made'for'effects'of'confounding'factors'that'
might'have'affected'the'outcomes'(e.g.,'multivariate'analyses)?'
8.6.! Was'clinical'significance'as'well'as'statistical'significance'reported?'
8.7.! If'negative'findings,'was'a'power'calculation'reported'to'address'type'2'error?'
9.! Are(conclusions(supported(by(results(with(biases(and(limitations(taken(into(
consideration?'
9.1.! Is'there'a'discussion'of'findings?'
9.2.! Are'biases'and'study'limitations'identified'and'discussed?'
9.1'
9.2'
10.! Is(bias(due(to(studys(funding(or(sponsorship(unlikely?(
10.1.!Were'sources'of'funding'and'investigators'affiliations'described?'
10.2.!Was'there'no'apparent'conflict'of'interest?'
Yes'
10.1' Yes'
10.2' Yes'
10'
MINUS/NEGATIVE((7)(
If!most!(six!or!more)!of!the!answers!to!the!above!validity!questions!are!No,!the!report!should!be!designated!with!a!minus!!
(?)!symbol!on!the!Evidence!Worksheet.'
NEUTRAL((!)!
If!the!answers!to!validity!criteria!questions!2,!3,!6,!and!7!do!not!indicate!that!the!study!is!exceptionally!strong,!the!report!
should!be!designated!with!a!neutral!(!)'symbol!on!the!Evidence!Worksheet.'
PLUS/POSITIVE((+)!
If!most!of!the!answers!to!the!above!validity!questions!are!Yes!(including!criteria!2,!3,!6,!7!and!at!least!one!additional!
Yes),!the!report!should!be!designated!with!a!plus!symbol!(+)!on!the!Evidence!Worksheet.'
'
Academy(of(Nutrition(and(Dietetics(
Evidence(Analysis(Library(Worksheet(Template(and(
Quality(Criteria(Checklist:(Primary(Research(
Citation'
Reviewed'by:'Kimber'Schrowang'
Jiang,'J.,'Qiu,'H.,'Zhao,'G.,'Zhou,'Y.,'Zhang,'Z.,'Zhang,'H.,''Xu,'W.CH.'(2012).'
Dietary'Fiber'Intake'Is'Associated'with'HbA1c'Level'among'Prevalent'Patients'with'
Type'2'Diabetes'in'Pudong'New'Area'of'Shanghai,'China.'PLoS'ONE,'7(10),'
e46552.'http://doi.org/10.1371/journal.pone.0046552'
'
Study'Design'
crossCsectionaly'study'
Class'
D'
Quality'Rating'
Research'Purpose'
Inclusion'Criteria'
Exclusion'Criteria'
'+'(Positive)'''
'C'(Negative)''
'!'(Neutral)'
observe'the'effects'of'DF'intake'on'HbA1c'levels'with'Type'2'Diabetes'patients''
Adult'with'DM2,'Pudong'Area,'consume'lower'levels'of'energy'and'macro,'FPG'>='
7'mmol/L'or'2'hr'plasma'glucose'>='11.1'mmol/L'or'rnadom'plasma'glucose'
concentration'>=11.1'mmol/L'in'persons'with'symptoms'of'hyperglycemia'or'
hyperglycemic'crisis'
not'diagnosed'with'DM2,'living'out'of'the'Pudong'Area,'not'meeting'the'glucose'
levels,'CV'even'withi'past'6'months,'advanced'CHF,'unstable'angina,'major'
depression'and'dementia'
Recruitment:''934'patients'randomly'selected'from'Diabetes'Administration'
Rosters'in'specified'communities'and'compared'to'918'adult'volunteers'without'
Type'2'Diabetes'from'the'spouses'and'neighbors'of'the'patients'in'the'same'area''
Design:''crossCsectional'study'
Description'of'
Study'Protocol'
Blinding'used'(if'applicable):''N/A'
Intervention'(if'applicable):''N/A'
Statistical'Analysis:''SAS'version'9.2,'natural'log'transformation'applied'to'
normalize'distribution'of'biochemical'measurements,'all'statistical'tests'based'on'
twoCsided'probability'
''''''
Timing'of'Measurements:'collected'at'interview,'blood'collected'after'10'hours'of'
Data'Collection'
Summary'
overnight'fasting'
Dependent'Variables:''HbA1c'levels'
Independent'Variables:''patients'with'DM2'
Control'Variables:'healthy'volunteers''
Initial:''1852''(41.7%'DM2,'31.7%'C'Males'''58.3%'DM2,'68.3%'C'Females)'
Attrition'(final'N):''926/918'
Description'of'
Actual'Data'Sample' Age:''64.5'+/C10.1'
Ethnicity:''Chinese'
diabetic'patients.'Glycemic'control'should'be'more'important'in'younger'patients'
and'estbalishing'"good"'dietary'habits.''
The$strengths$of$this$study$included$the$validated$food$frequency$questionnaire,$a$
standardized$protocol$for$body$measurements,$and$stringent$quality$control$in$lab$
assays.$Due$to$the$nature$of$the$cross<sectional$design,$however,$we$could$not$
Reviewer'
Comments'
elucidate$the$role$of$dietary$factors$in$glycemic$control.$Moreover,$the$amount$of$
energy$intake$appeared$lower$than$those$reported$in$previous$studies$[30],$raising$
our$concern$on$possible$recall$bias.$However,$the$potential$underestimation$of$
dietary$intake,$if$any,$would$result$in$a$non<differential$misclassification$bias,$
which$may$have$biased$our$results$towards$the$null.$
Shanghai'Municipal'Health'Bureau,'Academic'Leaders'Training'Program'of'Pudong'
Funding'Source'
Helath'Bureau'of'Shanghai'grant'
'
Quality(Criteria(Checklist:(Primary(Research(
Symbols(Used(
+(
77(
!(
Explanation(
Positive((Indicates'that'the'report'has'clearly'addressed'issues'of'inclusion/exclusion,'
bias,'generalizability,'and'data'collection'and'analysis(
Negative((Indicates'that'these'issues'have'not'been'adequately'addressed.(
Neutral('indicates'that'the'report'is'neither'exceptionally'strong'nor'exceptionally'
week(
Select'a'rating'from'the''
dropCdown'menu'!'
Relevance(Questions(
1.! Would'implementing'the'studied'intervention'or'procedure'(if'found'successful)'result'
in'improved'outcomes'for'the'patients/clients/population'group?'(NA'for'some'Epi'
studies)'
2.! Did'the'authors'study'an'outcome'(dependent'variable)'or'topic'that'the'
patients/clients/population'group'would'care'about?'
3.! Is'the'focus'of'the'intervention'or'procedure'(independent'variable)'or'topic'of'study'a'
common'issue'of'concern'to'dietetics'practice?'
4.! Is'the'intervention'or'procedure'feasible?'(NA'for'some'epidemiological'studies)'
1'
Yes'
2'
Yes'
3'
Yes'
4'
Yes'
If(the(answers(to(all(of(the(above(relevance(questions(are(Yes,(the(report(is(eligible(for(designation(with(a(
plus((+)(on(the(Evidence(Quality(Worksheet,(depending(on(answers(to(the(following(validity(questions.'
Validity(Questions'
1.! Was(the(research(question(clearly(stated?(
1.1.! Was'the'specific'intervention(s)'or'procedure'(independent'variable(s))'
identified?'
1.2.! Was'the'outcome(s)'(dependent'variable(s))'clearly'indicated?'
1.3.! Were'the'target'population'and'setting'specified?'
1'
1.3'
Yes'
Yes'
Yes'
Yes'
2.! Was(the(selection(of(study(subjects/patients(free(from(bias?(
2.1.! Were'inclusion/exclusion'criteria'specified'(e.g.,'risk,'point'in'disease'
progression,'diagnostic'or'prognosis'criteria),'and'with'sufficient'detail'and'
without'omitting'criteria'critical'to'the'study?'
2.2.! Were'criteria'applied'equally'to'all'study'groups?'
2.3.! Were'health,'demographics,'and'other'characteristics'of'subjects'described?'
2.4.! Were'the'subjects/patients'a'representative'sample'of'the'relevant'
population?'
2'
Yes'
2.1'
Yes'
2.2'
Yes'
2.3'
Yes'
2.4'
Yes'
3'
Yes'
3.1'
No'
3.2'
Yes'
3.3'
Yes'
3.4'
Yes'
3.5'
N/A'
3.6'
N/A'
4'
N/A'
4.1'
Unclear'
4.2'
Yes'
4.3'
Unclear'
3.! Were(study(groups(comparable?(
3.1.! Was'the'method'of'assigning'subjects/patients'to'groups'described'and'
unbiased?'(Method'of'randomization'identified'if'RCT)'
3.2.! Were'distribution'of'disease'status,'prognostic'factors,'and'other'factors'(e.g.,'
demographics)'similar'across'study'groups'at'baseline?'
3.3.! Were'concurrent'controls'used?'(Concurrent'preferred'over'historical'
controls.)'
3.4.! If'cohort'study'or'crossCsectional'study,'were'groups'comparable'on'important'
confounding'factors'and/or'were'preexisting'differences'accounted'for'by'using'
appropriate'adjustments'in'statistical'analysis?'
3.5.! If'case'control'study,'were'potential'confounding'factors'comparable'for'cases'
and'controls?'(If'case'series'or'trial'with'subjects'serving'as'own'control,'this'
criterion'is'not'applicable.'Criterion'may'not'be'applicable'in'some'crossC
sectional'studies.)'
3.6.! If'diagnostic'test,'was'there'an'independent'blind'comparison'with'an'
appropriate'reference'standard'(e.g.,'gold'standard)?'
1.1'
1.2'
'
'
4.! Was(method(of(handling(withdrawals(described?(
4.1.! Were'follow'up'methods'described'and'the'same'for'all'groups?(
4.2.! Was'the'number,'characteristics'of'withdrawals'(i.e.,'dropouts,'lost'to'follow'
up,'attrition'rate)'and/or'response'rate'(crossCsectional'studies)'described'for'
each'group?'(Follow'up'goal'for'a'strong'study'is'80%.)'
4.3.! Were'all'enrolled'subjects/patients'(in'the'original'sample)'accounted'for?'''
4.4.! Were'reasons'for'withdrawals'similar'across'groups'
4.5.! If'diagnostic'test,'was'decision'to'perform'reference'test'not'dependent'on'
results'of'test'under'study?'
5.! Was(blinding(used(to(prevent(introduction(of(bias?(
5.1.! In'intervention'study,'were'subjects,'clinicians/practitioners,'and'investigators'
blinded'to'treatment'group,'as'appropriate?(
5.2.! Were'data'collectors'blinded'for'outcomes'assessment?'(If'outcome'is'
measured''using'an'objective'test,'such'as'a'lab'value,'this'criterion'is'assumed'
to'be'met.)'
5.3.! In'cohort'study'or'crossCsectional'study,'were'measurements'of'outcomes'and'
risk''factors'blinded?''
5.4.! In'case'control'study,'was'case'definition'explicit'and'case'ascertainment'not'
influenced'by'exposure'status?'
5.5.! In'diagnostic'study,'were'test'results'blinded'to'patient'history'and'other'test'
results?'
6.! Were(intervention/therapeutic(regimens/exposure(factor(or(procedure(and(any(
comparison(s)(described(in(detail?(Were(intervening(factors(described?(
6.1.! In'RCT'or'other'intervention'trial,'were'protocols'described'for'all'regimens'
studied?'
6.2.! In'observational'study,'were'interventions,'study'settings,'and'
clinicians/provider'''described?'
6.3.! Was'the'intensity'and'duration'of'the'intervention'or'exposure'factor'sufficient'
to'produce'a'meaningful'effect?'
6.4.! Was'the'amount'of'exposure'and,'if'relevant,'subject/patient'compliance'
measured?'
6.5.! Were'coCinterventions'(e.g.,'ancillary'treatments,'other'therapies)'described?'
6.6.! Were'extra'or'unplanned'treatments'described?'
6.7.! Was'the'information'for'6.4,'6.5,'and'6.6'assessed'the'same'way'for'all'groups?'
6.8.! In'diagnostic'study,'were'details'of'test'administration'and'replication'
sufficient?'
7.! Were(outcomes(clearly(defined(and(the(measurements(valid(and(reliable?(
7.1.! Were'primary'and'secondary'endpoints'described'and'relevant'to'the'
question?'''
7.2.! Were'nutrition'measures'appropriate'to'question'and'outcomes'of'concern?'
7.3.! Was'the'period'of'followCup'long'enough'for'important'outcome(s)'to'occur?'
7.4.! Were'the'observations'and'measurements'based'on'standard,'valid,'and'
reliable'data'collection'instruments/tests/procedures?'
7.5.! Was'the'measurement'of'effect'at'an'appropriate'level'of'precision?'
7.6.! Were'other'factors'accounted'for'(measured)'that'could'affect'outcomes?'
7.7.! Were'the'measurements'conducted'consistently'across'groups?'
4.4'
Unclear'
4.5'
N/A'
5'
N/A'
5.1'
N/A'
5.2'
No'
5.3'
No'
5.4'
N/A'
5.5'
N/A'
6'
Yes'
6.1'
N/A'
6.2'
Yes'
6.3'
Yes'
6.4'
Unclear'
6.5'
N/A'
6.6'
N/A'
6.7'
N/A'
6.8'
N/A'
7'
Yes'
7.1'
Yes'
7.2'
Yes'
7.3'
Yes'
7.4'
Yes'
7.5'
Yes'
7.6'
Unclear'
7.7'
Yes'
8'
Yes'
8.1'
Yes'
8.2'
Yes'
8.3'
Yes'
8.4'
N/A'
'
'
'
'
8.! Was(the(statistical(analysis(appropriate(for(the(study(design(and(type(of(outcome(
indicators?((
8.1.! Were'statistical'analyses'adequately'described'the'results'reported'
appropriately?'
8.2.! Were'correct'statistical'tests'used'and'assumptions'of'test'not'violated?'
8.3.! Were'statistics'reported'with'levels'of'significance'and/or'confidence'intervals?'
8.4.! Was'intent'to'treat'analysis'of'outcomes'done'(and'as'appropriate,'was'there'
an'analysis'of'outcomes'for'those'maximally'exposed'or'a'doseCresponse'
analysis)?'
8.5.! Were'adequate'adjustments'made'for'effects'of'confounding'factors'that'
might'have'affected'the'outcomes'(e.g.,'multivariate'analyses)?'
8.6.! Was'clinical'significance'as'well'as'statistical'significance'reported?'
8.7.! If'negative'findings,'was'a'power'calculation'reported'to'address'type'2'error?'
9.! Are(conclusions(supported(by(results(with(biases(and(limitations(taken(into(
consideration?'
9.1.! Is'there'a'discussion'of'findings?'
9.2.! Are'biases'and'study'limitations'identified'and'discussed?'
10.! Is(bias(due(to(studys(funding(or(sponsorship(unlikely?(
10.1.!Were'sources'of'funding'and'investigators'affiliations'described?'
10.2.!Was'there'no'apparent'conflict'of'interest?'
8.5'
Yes'
8.6'
Yes'
8.7'
N/A'
Yes'
9.1'
Yes'
9.2'
Yes'
10'
Yes'
10.1' Yes'
10.2' Yes'
9'
MINUS/NEGATIVE((7)(
If$most$(six$or$more)$of$the$answers$to$the$above$validity$questions$are$No,$the$report$should$be$designated$with$a$minus$$
(<)$symbol$on$the$Evidence$Worksheet.'
NEUTRAL((!)$
If$the$answers$to$validity$criteria$questions$2,$3,$6,$and$7$do$not$indicate$that$the$study$is$exceptionally$strong,$the$report$
should$be$designated$with$a$neutral$(!)'symbol$on$the$Evidence$Worksheet.'
PLUS/POSITIVE((+)$
If$most$of$the$answers$to$the$above$validity$questions$are$Yes$(including$criteria$2,$3,$6,$7$and$at$least$one$additional$
Yes),$the$report$should$be$designated$with$a$plus$symbol$(+)$on$the$Evidence$Worksheet.'
'
Department of Pharmacology, Institute of Medicinal Plants, ACECR, No. 97 Bozorgmehr Street, Qods Street,
Enghelab Avenue, P.O. Box 13145-1446, Tehran, Iran
b Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences, Tehran, Iran
Department of Cultivation & Development, Institute of Medicinal Plants, ACECR, and Tarbiat Modarres University, Tehran, Iran
d Department of Biotechnology, Razi Institute, Karaj, Iran
Received 8 October 2004; received in revised form 12 May 2005; accepted 7 June 2005
Available online 8 September 2005
Abstract
Psyllium is a bulk-forming laxative and is high in both fiber and mucilage. The beneficial effect of dietary fiber in the management of type II
diabetes, has not been totally demonstrated. The purpose of this study was to determine the plasma-lowering effects of 5.1 g b.i.d. of psyllium
husk fiber, as an adjunct to dietary and drug therapy on lipid and glucose levels, in patients with type II diabetes. Patients were randomly
selected from an outpatient clinic of primary care to participate in a double-blind placebo-controlled study in which Plantago ovata Forsk., or
placebo was given in combination with their anti-diabetic drugs. Forty-nine subjects were included in the study that were given diet counseling
before the study and then followed for 8 weeks in the treatment period. Fasting plasma glucose (FBS) was measured every 2 weeks, and total
plasma cholesterol (TC), LDL-cholesterol (LDL-C), HDL-cholesterol (HDL-C), triglyceride (TG), and insulin levels were measured every
4 weeks. Glycosylated hemoglobin (HbA1c) was also measured at the beginning and ending of the study. The test products (psyllium or
placebo) were supplied to subjects in identically labeled foil packets containing a 5.1 g dose of product, to consume two doses per day, half
an hour before breakfast and dinner. Both products were well tolerated, with no serious adverse events related to treatment was reported in
either. Better gastric tolerance to metformin was recorded in the psyllium group. FBS, and HbA1c, showed a significant reduction (p < 0.05),
whereas HDL-C increased significantly (p < 0.05) following psyllium treatment. LDL/HDL ratio was significantly decreased (p < 0.05). Our
results show that 5.1 g b.i.d. of psyllium for persons with type II diabetes is safe, well tolerated, and improves glycemic control.
2005 Elsevier Ireland Ltd. All rights reserved.
Keywords: Blood glucose; Cholesterol; Clinical trial; Diabetes mellitus; HbA1c; Plantago ovata Forsk; Triglycerides
1. Introduction
Psyllium seeds from the Plantago ovata Forsk., belong
to the plantaginaceae family, contain 1030% mucilage.
Psyllium is a common ingredient in over-the-counter bulk
laxative products (Leung and Foster, 1996). Numerous
double-blind trials have found that supplementation with
0378-8741/$ see front matter 2005 Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.jep.2005.06.042
Psyllium (n = 21)
51.9
26.6
8.6
759
1.0
1.3
134
2.2a
Placebo (n = 15)
53.6
27.5
9.8
575
2.1
0.9
1.8
155
p-Value
0.586
0.516
0.597
0.375
203
2. Methods
This study was double-blind, placebo-controlled, and parallel. The study consisted of an 8-week treatment phase in
which subjects continued the diets and chemical drugs, but
were also randomly assigned to receive either 5.1 g psyllium
(psyllium group) or microcrystalline cellulose placebo (control group) twice daily. Subjects were instructed to consume
the test product 2030 min before the morning and evening
meals, by stirring the content of one packet into 250 ml of
water and drinking immediately. All patients completed a
consent form, and all of these outpatients had been given diet
counselling and were visited regularly in diabetes care clinic
every 2 months at least for 1 year before the study. A questionnaire consisted of demographic, blood pressure, familial
history of disease; concurrent disease, cigarette smoking and
drug therapy were completed at the screening time. All participants were evaluated; blood pressure and weight were
controlled and recorded in the screening period (at week 0)
and in the treatment period at weeks 2, 4, 6, and 8. Samples
of venous blood were taken for measurement of FBS, insulin,
HbA1c, TC, LDL-C, HDL-C, and triglyceride levels.
Results are shown based on mean S.E. of mean for each group.
2.2. Participants
A total of 57 patients, age 3570 years, whose diabetes
were controlled with diet only or diet plus glibenclamide
or metformin and volunteered to participate in the study
were admitted initially (Table 1). Forty-nine of them qualified for random assignment to treatment. Patients were
excluded from the study if they were receiving lipid-lowering
drugs, corticosteroids, other soluble fiber treatment, lithium,
carbamazepin, warfarin, digoxin or patients with clinically
significant renal, hepatic, gastrointestinal, pulmonary, and
thyroid disease. Individuals with a history of myocardial
infarction or major surgical procedures within the previous 6 months, as well as, a history of allergy to aspartame
or psyllium seed, or phenylketonuria were also excluded.
The trial was carried out in accordance with the Declaration of Helsinki and subsequent revisions, and approved by
the ethics committee at the Endocrinology and Metabolism
Research Center of Tehran University of Medical Sciences. The patient provided written informed consent for
participation.
2.5. Outcomes
Parameters measured were body weight, blood pressure
and fasting serum levels of glucose, HbA1c, insulin, and
lipid profile. FBS, HbA1c, TC, HDL-C, LDL-C, and triglycerides levels were measured with commercial kits by Rochehitachi 717 clinical chemistry autoanalyzer (Roche Diagnostics, Germany). Serum insulin and TSH levels were measured
by radioimmunoassay (Immunotech, France). All of the measurements were done by Bahar clinical laboratory in Tehran.
FBS was determined at weeks 0, 2, 4, 6, and 8; TC, HDL-C
and LDL-C insulin, and triglycerides levels at weeks 0, 4,
and 8; HbA1c at weeks 0 and 8.
204
Fig. 2. Mean (S.E.M.) of FBS levels in psyllium and placebo groups. FBS
decreased significantly in the psyllium group and in the weeks 6 and 8 the
difference between psyllium and placebo groups were significant, *p < 0.05.
216.2 25.3
216.5 11.3
36.2 2.4
142.1 10.4
193.4 20.9
9.1 0.8
10.5 0.6
4.1 0.5
8.3
2.0*
8.1
22.4
1.1
0.2*
0.3*
p-Value
Flatulence
Diarrhoea
Constipation
Reduced flushing
4
1
1
11
13
1
1
0
0.000
0.809
0.809
0.002
155.6
216.2
42.9
131.3
186.0
7.4
8.9
3.2
Placebo
161.6
11.0
7.2
1.9
6.8
18.6
0.7
3.1 0.3
4. Discussion
Results are shown based on mean S.E. of mean for each group.
p < 0.05 significant difference between placebo and psyllium groups.
*
179.1
224.3
48.9
131.8
219.0
8.3
9.1
2.8
12.7
8.5
2.1
8.2
20.2
0.8
0.7
0.2
208.2
207.2
40.2
126.0
217.6
7.5
10.5
3.24
FBS (mg/dl)
Total Cholesterol (mg/dl)
HDL-C (mg/dl)
LDL-C (mg/dl)
Triglycerides (mg/dl)
Insulin (U/ml)
HbA1c (%)
LDL/HDL
10.8
15.4
3.9
11.6
17.0
1.2
0.5
0.2
Psyllium
Placebo
Psyllium
178.4 12.7
194.1 13.4
169.3
193.9
39.8
108.3
207.6
8.0
2.8 0.2
10.9
9.7
2.5
9.7
25.3
0.8
193.6
204.4
40.2
119.2
239.3
8.9
Placebo
Psyllium
Week 2
Placebo
Psyllium
207.5 19.8
Psyllium
Psyllium
Week 6
Week 4
Effect
Week 0a
Table 2
Glucose and lipid profiles in the study groups
205
Table 3
Study of side effects in psyllium and placebo group
10.7*
Placebo
Week 8
9.5*
Placebo
206
Acknowledgements
The authors thank Endocrinology and Metabolism
Research Center of Tehran University of Medical Sciences,
which supported this work and Dr. S.A. Ebrahimi for his
help.
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Abstract
Background: Dietary factors play an important role in glycemic control in diabetic patients. However, little is known about
their effects among Chinese diabetic patients, whose diets are typically abundant in fiber and high in glycemic index (GI)
values.
Methodology/Principal Findings: 934 patients with type 2 diabetes and 918 healthy volunteers from Pudong New Area,
Shanghai, China, were interviewed during the period of Oct-Dec, 2006 to elicit demographic characteristics and lifestyle
factors. Dietary habits were assessed using a validated food frequency questionnaire. Anthropometric measurements, biospecimen collection and biochemical assays were conducted at the interview according to a standard protocol. In this
population, diabetic patients consumed lower levels of energy and macronutrients but had higher levels of fasting plasma
glucose (FPG), glycolated hemoglobin A1c (HbA1c), triglyceride and body mass index than healthy adults. While the average
consumption levels of the nutrients among diabetic patients did not vary along duration of the disease, the average levels
of FPG and HbA1c increased with increasing duration. Regardless of diabetes duration, HbA1c level was observed lower in
patients having a higher fiber or lower GI intake. Compared with those with the lowest tertile intake of fiber, the adjusted
odds ratios (ORs) for poor glycemic control reduced from 0.75 (95%CI: 0.541.06) to 0.51 (95%CI: 0.340.75) with increasing
tertile intake (P for trend ,0.001).
Conclusions: Dietary fiber may play an important role in reducing HbA1c level. Increasing fiber intake may be an effective
approach to improve glycemic control among Chinese diabetic patients.
Citation: Jiang J, Qiu H, Zhao G, Zhou Y, Zhang Z, et al. (2012) Dietary Fiber Intake Is Associated with HbA1c Level among Prevalent Patients with Type 2 Diabetes
in Pudong New Area of Shanghai, China. PLoS ONE 7(10): e46552. doi:10.1371/journal.pone.0046552
Editor: Noel Christopher Barengo, Fundacion para la Prevencion y el Control de las Enfermedades Cronicas No Transmisibles en America Latina (FunPRECAL),
Argentina
Received March 13, 2012; Accepted September 5, 2012; Published October 16, 2012
Copyright: 2012 Jiang et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This research was funded by Shanghai Municipal Health Bureau (08GWZX0201) and Academic Leaders Training Program of Pudong Health Bureau of
Shanghai (Grant No. PWRd2010-03). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: The authors have declared that no competing interests exist.
* E-mail: wanghong.xu@fudan.edu.cn (WX); ruan_118@hotmail.com (XR)
Introduction
Type 2 diabetes is an important risk factor for micro-vascular
and macro-vascular complications. Effective control of hyperglycemia, dyslipidemia and hypertension, either by medication or by
lifestyle intervention, is crucial to decrease the incidence of stroke,
myocardial infarction and renal disease, as well as the related
premature death [1,2]. Intervention studies have examined the
impact of dietary intake on glycemic control, and found that
higher intake of dietary fiber [3,4] and lower intakes of dietary fat
[5], glycemic index (GI) [6] and carbohydrate [7] improved
glycemic control status. In the Nurses Health Study, He, et al [8]
observed a potential benefit of whole grain, cereal fiber and bran
intake in reducing mortality and cardiovascular risk in diabetic
patients. None of these studies, however, were conducted in
Chinese population.
Data collection
A structured in-person interview was conducted for each subject
by trained interviewers to collect information on demographic
characteristics, duration of diabetes, age at onset of diabetes,
diagnosis of hypertension, presence of dyslipidemia, use of tobacco
and alcohol. Presence of hypertension, dyslipidemia and coronary
heart disease were defined by a positive response to the question of
Have you ever been diagnosed with hypertension/dyslipidemia/
coronary heart disease by a doctor?. Family history of diabetes
was defined as positive if any first- or second-degree relative had
type 2 diabetes. Smoking was defined as at least 1 cigarette per day
for at least 6 months, and alcohol use was defined as drinking
alcohol at least 3 times a week for more than 6 months.
Dietary habit was assessed using an interviewer-administered
food frequency questionnaire (FFQ) modified based on a validated
FFQ [13]. The FFQ specifies 103 food items, covering 90% of
food items commonly consumed in Shanghai. For each food item,
participants were asked to report how frequently (daily, weekly,
monthly, annually or never) and how long (months per year) they
consumed the food, followed by a question on the amount of
consumption in liang (1 liang = 50 g) per unit of time in previous 12
months. For liquid foods such as milk, juice and beverage, the
amount of intake was reported in milliliter (ml) and was
transformed into gram in the analysis. The daily intakes of oil,
salt and sugar were calculated as the average level consumed by
each family member of the participant.
Nutrient content from the Chinese Food Composition Tables
was applied to estimate nutrient intake from all food items and
groups, and to obtain GI values for most food items [14]. For the
remaining food items, we referenced Foster-Powell et als report to
obtain their GI values [15]. Glycemic load (GL) from each food
was calculated by multiplying the foods GI value by the
carbohydrate content of the food and the average amount of the
food consumed per day. Total dietary GL was then produced by
summing these products over all food items. Dietary GI was
derived by dividing the dietary GL by the amount of carbohydrate
intake, thus yielding a weighted average GI for each individuals
PLOS ONE | www.plosone.org
Statistical analysis
Statistical analyses were conducted utilizing SAS statistical
software 9.2 (SAS Institute Inc., Cary, NC). Differences on
demographic factors by diabetic status or glycemic control status
were evaluated using x2 test for categorical variables or nonparameter Wilcoxon test for continuous variables. Partial correlation analysis was conducted to evaluate the linear correlations of
HbA1c levels with amounts of dietary intake. A generalized linear
regression model was applied to compare the average levels of
biochemical measurements and average levels of dietary intake.
An unconditional logistic regression model was employed to
estimate the adjusted odds ratios (ORs) and 95% confident
intervals (CIs) of dietary intake with glycemic control status among
diabetic patients. Natural log transformation was applied to
normalize the distribution of biochemical measurements before
parametric methods were used in data analysis. All statistical tests
were based on two-sided probability.
Results
Compared with the recruited healthy volunteers, diabetic
patients were older and less educated, had more family history
of diabetes and higher prevalence of hypertension, dyslipidemia
and coronary heart disease (CHD), as shown in Table 1. Among
934 prevalent diabetic patients, 488 (52.3%) had an HbA1c level
of $7.0%. These patients, compared with those having an HbA1c
level of ,7.0%, appeared to have less education, younger age at
diagnosis of diabetes, longer duration of diabetes, lower prevalence
of hypertension and were more likely to use oral hypoglycemia
drug and insulin. No significant difference was observed between
the two groups with regard to age, sex, smoking, alcohol
Characteristics
Healthy adults
(N = 918)
Diabetic patients
(N = 934)
P value
Diabetic patients
P valuea
HbA1c,7.0% (N = 446)
HbA1c$7.0% (N = 488)
57.7 (9.9)
64.5 (10.1)
,0.001
64.6 (10.1)
64.4 (10.1)
0.825
291 (31.7)
389 (41.7)
,0.001
191 (42.8)
198 (40.6)
0.487
864 (92.5)
0.008
400 (89.9)
465 (94.9)
0.004
88 (9.6)
298 (31.9)
,0.001
130 (29.2)
168 (34.4)
0.084
55.2 (10.4)
56.4 (10.4)
54.2 (10.0)
0.002
9.2 (6.4)
8.2 (6.3)
10.2 (6.3)
,0.001
518 (55.5)
,0.001
265 (59.4)
253 (51.8)
0.020
97 (10.4)
0.004
55 (12.3)
42 (8.6)
0.062
132 (14.1)
,0.001
73 (16.4)
59 (12.1)
0.061
46 (5.0)
134 (46.1)
152 (39.1)
0.068
70 (36.7)
82 (41.4)
0.336
Women
6 (1.0)
5 (0.9)
0.944
2 (0.8)
3 (1.0)
1.000
113 (33.8)
108 (27.8)
0.002
49 (25.7)
59 (29.8)
0.362
Women
21 (3.4)
10 (1.8)
0.108
5 (2.0)
5 (1.7)
1.000
762 (81.5)
341(76.5)
421(87.0)
,0.001
88 (9.4)
31(7.0)
57(11.8)
0.012
Missing values (1 for age, education, diagnosis age of DM, duration of DM in diabetic patients; 1 for current alcohol consumption in healthy adults; 4 for oral
hypoglycemic drug use and insulin use) were excluded;
a 2
x test for categorical variables or non parameter Wilcoxon test for continuous variables.
doi:10.1371/journal.pone.0046552.t001
Discussion
In this cross-sectional study including 934 Chinese prevalent
patients with type 2 diabetes from Pudong New Area of Shanghai,
China, we observed a stable after-diagnosis dietary habit, upward
trend of HbA1c level along with duration of diabetes, a lower
average level of HbA1c related with higher fiber intake, and a
probably protective effect of dietary fiber on glycemic control
status. Our findings have several implications in improving
Table 2. Average levels of dietary intake by diabetic status and duration of type 2 diabetes.
Diabetic
Healthy adults patients
(N = 918)
(N = 934)
P valueb
59 (N = 316)
$10 (N = 387)
P valuec
Men
Energy, kcal/d
1931.2 (1.4)
1644.1 (1.3)
,0.001
1740.8 (1.3)
1600.0 (1.3)
1615.5 (1.3)
0.225
Carbohydrate, g/d
323.6 (1.4)
268.2 (1.3)
0.003
282.5 (1.3)
263.9 (1.3)
261.6 (1.3)
0.583
Protein, g/d
68.9 (1.4)
61.5 (1.5)
0.003
65.1 (1.5)
58.3 (1.4)
62.0 (1.4)
0.467
Fiber, g/d
10.2 (1.6)
9.2 (1.7)
0.232
9.9 (1.6)
8.4 (1.6)
9.6 (1.7)
0.045
Fat, g/d
40.9 (1.6)
37.1 (1.6)
0.002
40.0 (1.5)
35.3 (1.6)
36.9 (1.6)
0.485
Average GI
61.5 (1.1)
60.4 (1.2)
0.323
61.0 (1.2)
61.4 (1.1)
59.2 (1.2)
0.230
Average GL
104.7 (1.4)
87.6 (1.4)
0.347
93.3 (1.4)
84.0 (1.4)
86.5 (1.4)
0.670
Energy, kcal/d
1695.2 (1.3)
1410.5 (1.3)
,0.001
1445.2 (1.4)
1438.3 (1.4)
1367.4 (1.3)
0.438
Carbohydrate, g/d
279.2 (1.3)
226.3 (1.4)
,0.001
234.0 (1.4)
231.4 (1.4)
217.9 (1.4)
0.878
Protein, g/d
61.8 (1.4)
52.9 (1.5)
,0.001
54.3 (1.5)
53.7 (1.5)
51.2 (1.5)
0.973
Fiber, g/d
10.2 (1.6)
8.5 (1.7)
0.460
8.8 (1.7)
8.4 (1.7)
8.3 (1.7)
0.868
Fat, g/d
38.4 (1.6)
33.4 (1.6)
,0.001
33.5 (1.6)
33.8 (1.7)
32.9 (1.5)
0.797
Average GI
59.9 (1.1)
59.2 (1.2)
,0.001
59.3 (1.1)
59.6 (1.2)
58.7 (1.2)
0.733
Average GL
92.1 (1.4)
74.2 (1.4)
,0.001
76.8 (1.4)
75.7 (1.4)
71.5 (1.4)
0.783
Women
Continuous variables were all natural LOG transformed before entering models;
Generalized linear model adjusting for age, BMI and energy intake;
c
Generalized linear model adjusting for age, BMI, oral hypoglycemic drug use, insulin use and energy intake.
doi:10.1371/journal.pone.0046552.t002
b
Table 3. Average levels of metabolic indicators by diabetic status and duration of type 2 diabetes.
Diabetic
Healthy adultspatients
P valueb
P valuec
(N = 918)
(N = 934)
59 (N = 316) .9 (N = 387)
FPG, mmol/L
5.3 (1.2)
8.0 (1.4)
,0.001
7.2 (1.3)
8.1 (1.4)
8.5 (1.4)
,0.001
HbA1c (%)
5.9 (1.1)
7.4 (1.2)
,0.001
6.9 (1.2)
7.4 (1.2)
7.7 (1.2)
,0.001
TC, mmol/L
4.5 (1.2)
4.4 (1.2)
0.003
4.4 (1.2)
4.4 (1.2)
4.4 (1.2)
0.733
TG, mmol/L
1.3 (1.7)
1.4 (1.8)
,0.001
1.5 (1.8)
1.4 (1.7)
1.4 (1.8)
0.508
LDLC, mmol/L
2.8 (1.3)
2.7 (1.4)
,0.001
2.7 (1.4)
2.7 (1.3)
2.7 (1.4)
0.177
HDLC, mmol/L
Men
1.1 (1.3)
1.1 (1.2)
0.998
1.1 (1.2)
1.1 (1.1)
1.2 (1.1)
0.111
Women
1.3 (1.3)
1.3 (1.3)
0.224
1.3 (1.3)
1.3 (1.2)
1.3 (1.3)
0.266
24.8 (1.1)
25.6 (1.1)
0.005
25.8 (1.2)
25.7 (1.1)
24.8 (1.1)
0.002
BMI
a
Continuous variables were all natural LOG transformed before entering models;
Generalized linear model adjusting for age and gender;
Generalized linear model adjusting for age, gender, oral hypoglycemic drug use and insulin use.
doi:10.1371/journal.pone.0046552.t003
b
c
Figure 1. Average levels of HbA1c by duration of type 2 diabetes and dietary fiber or GI intake. The low and high fiber or GI intakes were
classified by the medians of consumption in men and women, respectively. Means of HbA1c level were adjusted for age (as a continuous variable),
sex (male/female), duration of type 2 diabetes (as a continuous variable), BMI (as a continuous variable), oral hypoglycemic drug use (yes/no), insulin
use (yes/no) and energy intake (as a continuous variable).
doi:10.1371/journal.pone.0046552.g001
Table 4. Associations of dietary intake with glycemic control status among diabetic patients.
Dietary intakea
HbA1c, % (Mean,
Glycemic control status, N (%)
SD)
Controlled (HbA1c,7.0%)
OR (95%CI)b
P for trend
Uncontrolled (HbA1c$7.0%)
Energy (kcal/d)
Low
7.5 (1.4)
143 (32.2)
165 (34.2)
1.00
Medium
7.6 (1.7)
139 (31.3)
170 (35.3)
High
7.5 (1.7)
162 (36.5)
147 (30.5)
Low
7.6 (1.5)
137 (30.9)
171 (35.5)
1.00
Medium
7.5 (1.6)
147 (33.1)
163 (33.8)
High
7.5 (1.8)
160 (36.0)
148 (30.7)
0.300
Carbohydrate (g/d)
0.166
Protein (g/d)
Low
7.6 (1.5)
135 (30.4)
172 (35.7)
1.00
Medium
7.5 (1.6)
151 (34.0)
159 (33.0)
High
7.5 (1.8)
158 (35.6)
151 (31.3)
0.052
Fiber (g/d)
Low
7.7 (1.5)
126 (28.4)
182 (37.8)
1.00
Medium
7.5 (1.5)
148 (33.3)
162 (33.6)
High
7.4 (1.8)
170 (38.3)
138 (28.6)
,0.001
Fat (g/d)
Low
7.5 (1.5)
139 (31.3)
168 (34.9)
1.00
Medium
7.4 (1.6)
167 (37.6)
144 (29.9)
High
7.7 (1.8)
138 (31.1)
170 (35.3)
0.630
Average GI
Low
7.5 (1.6)
145 (32.7)
163 (33.8)
1.00
Medium
7.4 (1.7)
165 (37.2)
144 (29.9)
High
7.7 (1.6)
134 (30.2)
175 (36.3)
0.184
Average GL
Low
7.6 (1.6)
141 (31.8)
166 (34.4)
1.00
Medium
7.6 (1.6)
139 (31.3)
172 (35.7)
High
7.5 (1.7)
164 (36.9)
144 (29.9)
0.154
a
Dietary factors were classified as low, medium and high intake by the tertiles in men and in women, respectively. The cut points for energy intake were 1444.06 and
1842.84 kcal/d in men and 1268.88 and 1623.31 kcal/d in women; for carbohydrate were 248.93 and 295.77 g/d in men and 205.85 and 267.65 g/d in women; for
protein intake were 50.89 and 72.42 g/d in men and 44.88 and 62.71 g/d in women; for fiber intake were 7.12 and 11.32 g/d in men and 6.73 and 10.51 g/d in women;
for fat were 31.02 and 44.62 g/d in men and 28.74 and 40.61 g/d in women; for average GI were 56.53 and 64.58 units/d in men and 55.88 and 62.95 units/d in women;
for average GL were 65.57 and 99.67 units/d in men and 76.34 and 87.55units/d in women.
b
OR, odds ratio; 95%CI, 95% confidence interval; OR: adjusted for age (as a continuous variable), sex (male/female), duration of type 2 diabetes (as a continuous
variable), BMI (as a continuous variable), oral hypoglycemic drug use (yes/no), insulin use (yes/no) and energy intake (as a continuous variable).
doi:10.1371/journal.pone.0046552.t004
Acknowledgments
Author Contributions
The authors are grateful to the study participants and research staff from
Community Health Centers in Pudong New Area of Shanghai, China.
References
4. Ziai SA, Larijani B, Akhoondzadeh S, Fakhrzadeh H, Dastpak A, et al.(2005)
Psyllium decreased serum glucose and glycosylated hemoglobin significantly in
diabetic outpatients. J Ethnopharmacol 102:202207.
5. Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, et al.(2006)
A low-fat vegan diet improves glycemic control and cardiovascular risk factors in
a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care
29:17771783.
6. Jenkins DJ, Kendall CW, McKeown-Eyssen G, Josse RG, Silverberg J, et
al.(2008) Effect of a low-glycemic index or a high-cereal fiber diet on type 2
diabetes: a randomized trial. JAMA 300:27422753.
7. Haimoto H, Sasakabe T, Wakai K, Umegaki H(2009). Effects of a lowcarbohydrate diet on glycemic control in outpatients with severe type 2 diabetes.
Nutr Metab (Lond) 6:21.
8. He M, van Dam RM, Rimm E, Hu FB,Qi L(2010). Whole-grain, cereal fiber,
bran, and germ intake and the risks of all-cause and cardiovascular diseasespecific mortality among women with type 2 diabetes mellitus. Circulation
121:21622168.
9. Zhou BF, Stamler J, Dennis B, Moag-Stahlberg A, Okuda N, et al.(2003)
Nutrient intakes of middle-aged men and women in China, Japan, United
Kingdom, and United States in the late 1990s: the INTERMAP study. J Hum
Hypertens 17:623630.
10. Yin WY, Zheng WD, Huang CY, Zhong HX, Li L, et al.(2005) [Investigation of
dietary fiber intakes and varies in 53 patients with diabetes]. Zhonghua Yu Fang
Yi Xue Za Zhi 39:342344.
11. Chandalia M, Garg A, Lutjohann D, von Bergmann K, Grundy SM, et al.(2000)
Beneficial effects of high dietary fiber intake in patients with type 2 diabetes
mellitus. N Engl J Med 342:13921398.
12. Liu Z, Fu C, Wang W, Xu B(2010). Prevalence of chronic complications of type
2 diabetes mellitus in outpatients -a cross-sectional hospital based survey in
urban China. Health Qual Life Outcomes 8:62.
13. Shu XO, Yang G, Jin F, Liu D, Kushi L, et al.(2004) Validity and
reproducibility of the food frequency questionnaire used in the Shanghai
Womens Health Study. Eur J Clin Nutr 58:1723.
14. Yang YX, Wang GY, Pan XC(2002). China Food Composition Tables 2002.
Beijing University Medical Press.
15. Foster-Powell K, Holt SH, Brand-Miller JC(2002). International table of
glycemic index and glycemic load values: 2002. Am J Clin Nutr 76:556.
16. Hessler DM, Fisher L, Mullan JT, Glasgow RE, Masharani U(2010). Patient
age: A neglected factor when considering disease management in adults with
type 2 diabetes. Patient Educ Couns
17. Roush G, Salonga A, Bajaj N(2011). A longitudinal study of sociodemographic
predictors of hemoglobin A1c. Conn Med 75:325328.
18. Khattab M, Khader YS, Al-Khawaldeh A, Ajlouni K(2010). Factors associated
with poor glycemic control among patients with type 2 diabetes. J Diabetes
Complications 24:8489.
ABSTRACT
Background The effect of increasing the intake of
IETARY guidelines for patients with diabetes mellitus were revised by the American Diabetes Association (ADA) earlier
this year.1 The ADA recommends that the
composition of the diet be individualized on the basis
of a nutritional assessment and the outcomes desired.
Consistent with the previous recommendations of
the ADA,2 the new guidelines advise replacing satu1392
VON
BERGMANN, M.D.,
TABLE 1. COMPOSITION
Diets
The composition of the study diets is shown in Table 1. The
composition of the diets was calculated by means of a software
program based on the Department of Agriculture Handbook Series 8 (Nutriplanner, Practocare, San Diego, Calif.).15 The content
of total as well as soluble and insoluble dietary fiber was estimated
according to the data provided in the CRC Handbook of Dietary
Fiber in Human Nutrition.16 Both diets consisted of unfortified
foods. The patients were allowed some choices of food items.
Both diets provided 15 percent of the total energy as protein, 55
percent as carbohydrate, and 30 percent as fat; saturated, cis monounsaturated, and polyunsaturated fats accounted for 7 percent, 17
percent, and 6 percent of the total energy, respectively.
The high-fiber diet provided 50 g of total fiber per day; soluble
and insoluble fiber content provided 25 g each. The ADA diet
contained 24 g of total fiber per day, with 8 g as soluble fiber and
16 g as insoluble fiber. Unfortified foods, particularly those rich
STUDY DIETS.
ADA
DIET*
CONSTITUENT
OF THE
HIGH-FIBER
DIET
55
15
30
7
17
6
300
55
15
30
7
17
6
297
24
8
16
50
25
25
OF THE
ADA DIET
FOOD
STUDY DIETS.*
HIGH-FIBER DIET
WEIGHT
FOOD
WEIGHT
grams
grams
Breakfast
Orange juice
White grits
Egg substitute
Olive oil
Decaffeinated coffee
220
50
40
10
2
Orange sections
Oatmeal
Scrambled egg
Olive oil
Decaffeinated coffee
300
50
37
10
2
Lunch
Ham (5% fat)
Mayonnaise
Iceberg lettuce
Fresh tomato
Low-sodium bread
Corn (canned)
Cider vinegar
Dehydrated onion
Olive oil
Fresh green pepper
Fresh celery
Fruit cocktail (canned)
Instant tea
Oatmeal raisin cookie
50
6
15
30
60
140
5
2
10
10
15
105
2
20
52
12
10
15
60
40
110
2
10
10
15
250
2
Dinner
Chicken breast (skinned)
Bran flakes
Low-sodium bread
Parmesan cheese
Whole egg
Tomato (canned)
Low-fat cheese
Spaghetti
Green beans
Olive oil
Whole-wheat bread
Graham crackers
Instant tea
90
10
20
1
1
120
11
45
75
17
21
21
2
90
10
5
1
10
105
19
19
195
19
30
300
2
Bedtime snack
Mozzarella cheese
Low-sodium bread
Pineapple juice
30
30
190
200
100
15
*Each menu provided 2308 kcal per day. ADA denotes American Diabetes Association.
Volume 342
The New England Journal of Medicine
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Copyright 2000 Massachusetts Medical Society. All rights reserved.
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1393
in soluble fiber, such as cantaloupe, grapefruit, orange, papaya, raisins, lima beans, okra, sweet potato, winter squash, zucchini, granola, oat bran, and oatmeal, were used to achieve high-fiber intake.
No fiber supplements were used. Sample menus of both the study
diets are shown in Table 2. The individual foods were weighed
daily during meal preparation in the research kitchen of the general clinical research center.
Biochemical Analyses
Fasting plasma total cholesterol, lipoprotein cholesterol, and triglycerides were measured according to the procedures of the Lipid Research Clinics.17 Cholesterol and triglycerides were measured
enzymatically with the use of kits (Boehringer Mannheim, Indianapolis). Very-low-density lipoproteins (VLDLs) (density, less
than 1.006 g per milliliter) were removed by ultracentrifugation,
and cholesterol was measured in the VLDL fraction and the infranatant. High-density-lipoprotein (HDL) cholesterol was measured enzymatically after lipoproteins containing apolipoprotein B
had been precipitated with heparinmanganese. Cholesterol in
the low-density lipoprotein (LDL) fraction was estimated to be
the difference between the cholesterol content of the infranatant
and that of the HDL fraction.
Plasma and urinary glucose were measured by the glucose oxidase method (Beckman Glucose Analyzer, Beckman Instruments,
Fullerton, Calif.). Glycosylated hemoglobin was measured with
ion-exchange high-performance liquid chromatography (Bio-Rad
Laboratories, Hercules, Calif.). Plasma insulin was measured by
radioimmunoassay.18,19
Pooled fecal samples collected within the last week of each dietary period were prepared for analysis of neutral and acidic fecal
sterols as described previously.20 Gasliquid chromatography of
neutral and acidic fecal sterols was performed on a gas chromatograph (model HP5890, HewlettPackard, Palo Alto, Calif.)
equipped with an automatic sample injector. Cholesterol absorption was measured during the same period from fecal samples by
gasliquid chromatography and mass spectrometry. 21
Statistical Analysis
To compare the two study periods and to assess the effect of
the sequence in which the patients received the high-fiber and
RESULTS
The compliance with both the study diets was excellent, according to interviews with the patients and
estimates of the energy content of any leftover foods.
Three patients reported consuming extra food on
one day during the study, two while eating the highfiber diet and one the ADA diet. The patients commented about the larger quantities of food in the
high-fiber diet, but they consumed all the food given to them. The results are presented irrespective of
the order of the diets, because the sequence of the
diets had no effect on the results.
During the last week of each study period, the patients in both groups had similar daily energy intakes
and body weights and received a similar dose of glyburide (Table 3). The mean plasma glucose concentration was lower (by 13 mg per deciliter [0.7 mmol
per liter], or 8.9 percent) when patients completed
the high-fiber diet than when they completed the
ADA diet (P=0.04), and mean daily urinary glucose
excretion was 1.3 g lower (P=0.008). Daily plasma
glucose concentrations were 10 percent lower with
the high-fiber diet than with the ADA diet (values
for the area under the curve, 3743944 vs. 3365
1003 mghour per deciliter [207.852.4 vs. 186.8
55.7 mmolhour per liter]; P=0.02), and plasma insulin concentrations were 12 percent lower (values
for the area under the curve, 1107650 vs. 971
491 Uhour per milliliter [66423900 vs. 5826
2946 pmolhour per liter]; P=0.05) (Fig. 1). Gly-
VARIABLE
ADA DIET
2308236
90.713.3
10.08.7
14236
2.34.3
0.76
7.21.3
HIGH-FIBER
DIET
OF THE
STUDY PERIODS
DIFFERENCE BETWEEN
DIETS (95% CI)
2308236
13038
13 (24 to 1)
1.01.9
0.0
6.91.2
P VALUE
1.00
0.60
1.00
0.04
0.008
0.09
*Plusminus values are means SD. ADA denotes American Diabetes Association, and CI confidence interval.
An analysis of variance was used to compare the two diets, except for urinary glucose, for which
the Wilcoxon signed-rank test was used.
The values are averages of plasma glucose concentrations measured at 7 and 11 a.m. and at 4 and
8 p.m. each day for five days during hospitalization. To convert values for plasma glucose to millimoles per liter, multiply by 0.056.
The values are averages of five daily urine collections during hospitalization.
1394
240
P<0.05
200
P<0.05
P<0.05
180
160
140
ADA diet
High-fiber diet
120
100
a.
m
.
9
a.
m
.
11
a.
m
.
1
p.
m
.
3
p.
m
.
5
p.
m
.
7
p.
m
.
9
p.
m
.
11
p.
m
.
1
a.
m
.
3
a.
m
.
5
a.
m
.
7
a.
m
.
220
100
80
60
40
ADA diet
20
High-fiber diet
a.
m
.
9
a.
m
.
11
a.
m
.
1
p.
m
.
3
p.
m
.
5
p.
m
.
7
p.
m
.
9
p.
m
.
11
p.
m
.
1
a.
m
.
3
a.
m
.
5
a.
m
.
7
a.
m
.
Time
Figure 1. Mean (SE) 24-Hour Profile of Plasma Glucose Concentrations (Panel A) and Insulin Concentrations (Panel B) during the Last Day of the American Diabetes Association (ADA) Diet and the Last
Day of the High-Fiber Diet in 13 Patients with Type 2 Diabetes Mellitus.
The arrows indicate the times at which the main meals and a snack were consumed during the day.
To convert values for glucose to millimoles per liter, multiply by 0.056. To convert values for insulin to
picomoles per liter, multiply by 6.
cosylated hemoglobin values were slightly lower after the high-fiber diet (P=0.09).
As compared with the ADA diet, the high-fiber
diet resulted in a lower fasting plasma total cholesterol concentration (by 6.7 percent, P=0.02), a lower
plasma triglyceride concentration (by 10.2 percent,
P=0.02), and a lower plasma VLDL cholesterol concentration (by 12.5 percent, P=0.01) (Table 4). The
fasting plasma LDL cholesterol concentration was
6.3 percent lower with the high-fiber diet (P=0.11).
There were no significant differences between the
Numb er 19
1395
VARIABLE
HIGHDIFFERENCE BETWEEN
P
FIBER DIET
DIETS (95% CI)
VALUE
mg/dl
Plasma
Plasma
Plasma
Plasma
Plasma
total cholesterol
triglycerides
VLDL cholesterol
LDL cholesterol
HDL cholesterol
0.02
0.02
0.01
0.11
0.80
We are indebted to Angela Osborn, Travis Petricek, and the nursing and dietetic service of the General Clinical Research Center of
the University of Texas Southwestern Medical Center, Dallas, for
their excellent technical support and to Beverley Adams-Huet, M.S.,
for statistical analysis.
REFERENCES
1. Nutrition recommendations and principles for people with diabetes
mellitus. Diabetes Care 2000;23:S43-S46.
2. American Diabetes Association. Nutritional recommendations and principles for individuals with diabetes mellitus: 1986. Diabetes Care 1987;10:
126-32.
3. Garg A, Bonanome A, Grundy SM, Zhang Z-J, Unger RH. Comparison of a high-carbohydrate diet with high-monounsaturated-fat diet in patients with non-insulin-dependent diabetes mellitus. N Engl J Med 1988;
319:829-34.
4. Rivellese AA, Giacco R, Genovese S, et al. Effects of changing amount
of carbohydrate in diet on plasma lipoproteins and apolipoproteins in type
II diabetic patients. Diabetes Care 1990;13:446-8.
5. Parillo M, Rivellese AA, Ciardullo AV, et al. A high-monounsaturatedfat/low-carbohydrate diet improves peripheral insulin sensitivity in noninsulin-dependent diabetic patients. Metabolism 1992;41:1373-8.
6. Rasmussen OW, Thomsen C, Hansen KW, Vesterlund M, Winther E,
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The New England Journal of Medicine
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1398
Research Article
Fiber in Diet Is Associated with Improvement of
Glycated Hemoglobin and Lipid Profile in Mexican
Patients with Type 2 Diabetes
Lubia Velzquez-Lpez,1 Abril Violeta Muoz-Torres,2 Carmen Garca-Pea,3
Mardia Lpez-Alarcn,4 Sergio Islas-Andrade,5 and Jorge Escobedo-de la Pea1
1
Unidad de Investigacion en Epidemiologa Clnica, Hospital Carlos MacGregor Sanchez Navarro, Instituto Mexicano del Seguro
Social, Avenida Gabriel Mancera No. 222, Colonia del Valle, Delegacion Benito Juarez, 03100 Ciudad de Mexico, Mexico
2
Departamento de Salud Publica, Facultad de Medicina, Universidad Nacional Autonoma de Mexico, 6 Piso, Edificio B,
Circuito Interior, Ciudad Universitaria, Avenida Universidad 3000, Ciudad de Mexico, Mexico
3
Departamento de Investigacion, Instituto Nacional de Geriatra, Periferico sur No. 2767, Colonia San Jeronimo Ldice,
Delegacion Magdalena Contreras, 10200 Ciudad de Mexico, Mexico
4
Unidad de Investigacion Medica en Nutricion, Hospital de Pediatra, Centro Medico Nacional Siglo XXI, Instituto Mexicano del
Seguro Social, Avenida Cuauhtemoc 300, Colonia Doctores, Delegacion Cuauhtemoc, 06720 Ciudad de Mexico, Mexico
5
Unidad de Investigacion Cientfica de Endocrinologa, Diabetes y Metabolismo, y de Enfermedades Metabolicas,
Centro Medico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Avenida Cuauhtemoc 300, Colonia Doctores,
Delegacion Cuauhtemoc, 06720 Ciudad de Mexico, Mexico
Correspondence should be addressed to Jorge Escobedo-de la Pena; jorgeep@unam.mx
Received 22 November 2015; Revised 26 February 2016; Accepted 21 March 2016
Academic Editor: Giovanni Annuzzi
Copyright 2016 Lubia Velazquez-Lopez et al. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
cited.
Objective. To assess the association of dietary fiber on current everyday diet and other dietary components with glycated hemoglobin
levels (HbA1c), glucose, lipids profile, and body weight body weight, in patients with type 2 diabetes. Methods. A cross-sectional
survey of 395 patients with type 2 diabetes was performed. HbA1c, fasting glucose, triglycerides, and lipids profile were measured.
Weight, waist circumference, blood pressure, and body composition were measured. Everyday diet with a semiquantitative food
frequency questionnaire was evaluated. ANOVA, Kruskal-Wallis, chi-square tests and multivariate logistic regression were used
in statistical analysis. Results. Higher fiber intake was associated with a low HbA1c, high HDL-c levels, low weight, and waist
circumference. The highest tertile of calories consumption was associated with a higher fasting glucose level and weight. The highest
tertile of carbohydrate consumption was associated with a lower weight. The lowest tertile of total fat and saturated fat was associated
with the highest tertile of HDL-c levels, and lower saturated fat intake was associated with lower weight ( < 0.05). Conclusions. A
higher content of fiber in the diet reduces HbA1c and triglycerides, while improving HDL-c levels. Increasing fiber consumption
while lowering calorie consumption seems to be an appropriate strategy to reduce body weight and promote blood glucose control.
1. Introduction
Increased fiber in the diet is associated with a reduction of
glycated hemoglobin (HbA1c), improved lipid profile, and
loss of body weight in type 2 diabetes patients. It has been
proposed that appropriate consumption of fruit in the diet
may be an adequate strategy to reduce HbA1c, given the
fiber content, and prevent complications from diabetes [1, 2].
2
serum lipid levels continues to generate controversy [6]. It
has also been suggested that reducing the proportion of
carbohydrates in the diet at the cost of increasing protein
consumption improves HbA1c and blood pressure values
as well as weight loss and this, combined with physical
exercise, proffers greater protection [7]. The recommendation
to include fats in the diet continues to stir up controversy
regarding the effect of this on the lipids profile and body
weight; strategies include reducing to 30% or less the calorie
intake. Conversely, higher consumption has been suggested
though with a higher content of monounsaturated and
polyunsaturated fats [8].
Type 2 diabetes is one of the chronic diseases with
the highest economic and social impact, as well as in the
repercussions on the quality of life. In recent decades it has
reached epidemic proportions; lifestyle is a very important
factor in the prevention and control of the disease [9]. There is
evidence of the favorable effect of adequate glycemic control
to prevent micro- and macrovascular complications [10].
In the treatment regime, diet adaptation is a basic element
to achieve and maintain control goals [11]. Even while diet
plays a substantial role, only a minority of patients receive
nutriment therapy, and an even smaller number undergo the
needed changes in diet as part of their disease management
[12].
Fiber consumption used to be high in the Mexican
population; however, it has been reduced due to changes in
eating habits [13] which undoubtedly affects habitual diet in
subjects with diabetes. While there is limited information on
the description of current everyday diet in patients with type
2 diabetes and its effect on major cardiovascular risk factors,
the role of macronutrients on metabolic control indicators
continues to foster controversy [14]. Given the foregoing,
the objective of this study was to assess the association
of habitual dietary fiber and other dietary components on
HbA1c, glucose, and lipid profile levels, as well as body
weight, in type 2 diabetes patients in Mexico.
2. Methods
This report corresponds to the baseline evaluation of type
2 diabetes patients that were included in a multicenter,
randomized clinical trial called Efficacy of Nutritional Therapy and Education through a Multimedia System for the
Metabolic Control of Type 2 Diabetes Patients (ClinicalTrials.gov identifier: NCT02441023). Patients came from four
different primary care clinics (family medical units belonging
to the Mexican Social Security Institute) in Mexico City, with
a previous diagnosis of diabetes, with age younger than 70
years, and with no advanced microvascular complication.
An ethics and research committee approved the protocol.
Patients were invited to participate at their local clinics and
incorporated into the study once they had signed the letter of
informed consent.
The patients included in the study underwent an extensive
medical history questionnaire as well as a physical examination to evaluate the presence of severe complications.
Hypertension was diagnosed when the patient stated being
(%)
54.6 8.0
270 (68)
125 (32)
6 (311)
16 (4)
300 (76)
43 (11)
36 (9)
84 (21)
65 (16)
51 (13)
129 (33)
219 (55)
89 (22)
132 (33)
77 (20)
22 (6)
18 (5)
49 (12)
18 (5)
A one-factor analysis of variance was performed to identify the association between the main dietary components
with metabolic control variables; the Kruskal-Wallis test was
used for glucose and triglyceride variables. The chi-square
test was used to identify the association between a balanced
diet and the various components of metabolic control.
A logistic regression multivariate analysis was performed
to identify the risk of HbA1c >7% if the dietary components
were inadequate. The model was adjusted with the variables
that could influence metabolic controls, such as the number
of years elapsed since the time of diagnosis, the type of treatment given, and diabetes education. Data were considered
statistically significant with a < 0.05. Statistical analysis was
done using the SPSS package, version 19.
3. Results
The average age of the study population was 54.6 8.0
years; oral hypoglycemic drugs were the most-used diabetes treatment (76%); a low proportion followed a diet
and physical activity (16% and 13%, resp.). Only 21% were
prescribed lowering lipid medication. Of the study group,
55% had hypertension, 26% had diabetic neuropathy, 12% had
microalbuminuria, and 5% had macroalbuminuria (Table 1).
4. Discussion
In patients with type 2 diabetes, adherence to an appropriate
meal plan and physical activity are important components
in controlling the disease. Of the population assessed, only
16% of patients followed a diet as part of their treatment and
only 13% exercised. As for metabolic control, only 3 out of
10 patients had HbA1c <7%, a proportion similar to what is
reported in the National Health Survey of Mexico 2012, in
which only a small group adheres to diet and exercise regimes
as part of treatment, and only 24% have an adequate glycemic
control [22].
Regarding the characteristics of the diet, only 2 out of
10 patients have adequate consumption of whole simple
carbohydrates, only 16% consume adequate proportions of
fat, and only 8% have a proper balance in their daily diet,
even though 4 out of 10 patients are consuming a diet
conducive to attaining healthful body weight (1,200 to 1,600
Biochemical variables
HbA1c (%)
Reference value
Adequate control
(%)
8.48 2.2
<7%
112.46 32.0
<100 mg/dL
70 (25.9)/41 (33)
0.71.3 mg/dL
387 (98)
136 (34)
146 (117201)
70130 mg/dL
149 (38)
195.90 41.1
<200 mg/dL
229 (58)
LDL-c (mg/dL)
HDL-c (mg/dL)
Triglycerides (mg/dL)
Creatinine (mg/dL)
Anthropometric variables and blood pressure (BP)
Weight (kg)
Body mass index (kg/m2 )
Diet variables
Total energy kcal/day1
Carbohydrates (g/day)/%
Soluble CHO g/day
Proteins g/day/%
Fats g/day/%
Dietary fiber g/1000 kcal
Saturated fats g/day/%
Fructose g/day
Cholesterol mg/day
Sodium mg/day
Balanced diet2
128 (32)
41.68 11.2
75.42 14.8
47 (12)
100.48 12.4
18.524.9 kgm2
12 (4)/24 (19)
41.90 11.7
5 (4)/12 (4)
83.25 11.1
130 mmHg
224 (57)
1792.25 683.2
225.65 93.6/50.3 7.8
59.00 (37.8770.81)/13.1 4.5
67.59 23.3/15.5 3.0
70.02 28.8/36.0 7.0
13.83 0.4
20.24 9.4/10.1 2.2
20 (1427)
195 (129252)
1492.57 594.0
80 mmHg
2030 kcal/kg/day
5055%
<10%
1015%
2530%
14 g/1000 Kcal
<7%
(20 g)/day
<200 mg
<2000 mg
179 (45)
97 (25)
97 (25)
188 (48)
64 (16)
188 (48)
28 (7)
195 (49)
212 (54)
269 (82)
30 (8)
180 (134251)
0.81 0.2
30.52 5.3
124.50 15.9
<150 mg/dL
134 (34)
324 (83)
1
Caloric recommendations for adults older than 51 years and sedentary behavior were considered, as well as a caloric reduction for subjects with diabetes,
obesity, or overweight; in normal weight, 30 kcal/kg/day was considered in reference value, in overweight, 25 kcal/kg/day, and, in obesity, 20 kcal/kg/day.
2
Balanced diet was considered when the proportion of carbohydrates was between 50 and 55%, proteins 1015%, and fats < 30% from total kcal value. F:
female. M: male.
Tertiles
Calories (kcal)
8121440
14411922
19223420
value
Carbohydrates (g/day)
116.45211.36
211.37238.80
238.81298.50
value
Proteins (g/day)
40.7263.06
63.0770.36
70.3798.24
value
Fats (g/day)
12.9264.50
64.5174.77
74.78149.02
value
Saturated fats (g/day)
1.1818.20
18.2121.89
21.9054.28
value
Dietary fiber (g/day)
4.6321.65
21.6626.68
26.6978.38
value
Glucose
mg/dL
Triglycerides
mg/dL
HDL-c
mg/dL
LDL-c
mg/dL
8.40 2.1
8.35 2.3
8.70 2.3
0.400
41.8 10.6
41.1 9.7
42.2 13.1
0.719
113.9 31.2
111.7 31.5
111.6 33.2
0.811
8.6 2.1
8.4 2.3
8.4 2.3
0.767
40.6 10.0
41.4 13.4
43.1 10.1
0.202
108.0 32.0
116.1 33.2
112.5 29.2
0.117
8.5 2.3
8.7 2.4
8.2 2.0
0.166
42.1 9.7
42.0 12.9
41.2 11.05
0.776
117.9 30.11
110.3 31.8
110.21 33.3
0.080
8.5 2.3
8.5 2.3
8.4 2.1
0.859
43.9 13.3
40.1 10.1
41.6 9.7
0.017
112.3 29.0
114.4 34.7
110.6 31.1
0.633
8.3 2.1
8.7 2.4
8.5 2.2
0.260
43.9 9.9
40.0 9.8
41.1 13.4
0.015
116.8 28.2
112.9 34.6
107.6 31.7
0.065
8.6 2.3
8.8 2.3
8.0 2.1
0.011
42.0 12.8
39.5 9.0
43.5 11.2
0.016
114.5 31.5
111.0 33.7
111.8 30.5
0.622
Data are presented as mean standard deviation or median (interquartile range), according to each tertile of diet components. Comparison was performed
with ANOVA (means) or Kruskal-Wallis (medians).
Tertiles
Calories (kcal)
8121440
14411922
19223420
value
Carbohydrates (g/day)
116.45211.36
211.37238.80
238.81298.50
value
Proteins (g/day)
40.7263.06
63.0770.36
70.3798.24
value
Fats (g/day)
12.9264.50
64.5174.77
74.78149.02
value
Saturated fats (g/day)
1.1818.20
18.2121.89
21.9054.28
value
Dietary fiber (g/day)
4.6321.65
21.6626.68
26.6978.38
value
Weight (kg)
72.6 13.6
76.4 16.0
77.3 14.6
0.022
99.4 12.2
100.9 12.6
101.2 12.6
0.458
29.8 5.0
31.0 5.5
30.8 5.3
0.145
42.4 11.1
41.9 11.3
41.4 12.9
0.782
78.1 16.0
74.2 14.5
73.8 13.6
0.035
101.4 12.5
100.6 12.4
99.4 12.4
0.416
30.8 5.3
30.4 5.3
30.2 5.3
0.654
41.2 11.3
42.7 12.3
41.7 11.7
0.572
75.9 14.1
74.5 15.1
75.8 15.4
0.705
101.5 12.2
99.8 12.4
100.2 12.6
0.528
30.9 5.4
30.2 4.9
30.4 5.6
0.538
43.2 11.9
41.9 11.1
40.5 12.2
0.172
75.0 14.5
74.3 14.1
76.9 15.9
0.347
101.0 12.4
99.7 12.3
100.7 12.5
0.698
30.5 5.4
30.3 5.2
30.7 5.3
0.853
40.9 12.1
42.6 11.7
42.1 11.5
0.462
72.6 13.5
75.9 15.4
77.7 15.3
0.020
99.2 12.8
100.4 11.8
101.8 12.6
0.223
29.8 5.2
30.7 5.3
31.0 5.3
0.183
40.9 12.2
42.7 11.0
42.0 12.0
0.450
78.1 14.2
74.1 14.9
73.9 15.2
0.037
102.5 12.2
99.3 11.5
99.5 13.3
0.063
31.0 5.2
30.1 5.0
30.4 5.6
0.407
42.2 12.5
41.9 10.9
41.5 11.9
0.888
Data are presented as mean standard deviation, according to each tertile of diet components. Comparison was performed with ANOVA.
reported regarding the prevention of micro- and macrovascular complications [31]. Despite the foregoing, education
continues to be an underused approach; we must insist on
its use as a measure to promote a healthful lifestyle and a
better care of the disease. Comprehensive treatment should
be aimed at obtaining adequate metabolic control and at
encouraging the detection and timely medical and nutritional
treatment of diabetes [32].
5. Conclusions
A higher content of fiber in the diet had an impact on
reducing HbA1c and triglycerides, while improving HDL-c
levels. Lower calorie and saturated fat consumption may still
be an appropriate strategy to reduce body weight, promote
blood glucose control, and improve HDL-c levels. Since
metabolic control is deficient in Mexicans, we must insist
on a higher fiber content in the diet, given the beneficial
CI95%
value
0.461.41
0.752.41
0.459
0.309
1.223.83
1.083.35
0.008
0.024
1.283.99
1.013.78
0.005
0.029
2.3220.86
1.7016.35
0.272.36
0.001
0.004
0.683
1.353.42
0.002
0.511.38
0.496
0.492.25
0.482.16
0.890
0.950
Inadequate glycemic control (HbA1c > 7%), odds ratios (OR), and 95%
confidence intervals (CI95% ). Calories and dietary fiber are presented in
tertiles. BMI: body mass index. Individuals were considered of normal weight
with BMI < 24.9, overweight with 2529.9, and obesity > 30 kg/m2 .
Ethical Approval
This study was conducted according to the guidelines laid
down in the Declaration of Helsinki and all procedures
involving human subjects/patients were approved by the
Ethics and Health Research Committee of the Mexican Social
Security Institute.
Consent
Written informed consent was obtained from all subjects/patients.
Competing Interests
The authors declare that they have no competing interests.
CI95%
value
0.561.83
0.471.58
0.977
0.640
0.571.94
0.983.27
0.873
0.059
0.802.62
0.602.12
0.211
0.701
0.452.24
0.291.46
0.486.90
0.930
0.300
0.369
0.892.37
0.133
0.922.61
1.001.03
0.103
0.046
1.023.39
0.652.17
0.040
0.573
0.722.43
0.612.35
0.366
0.590
0.612.35
1.001.03
0.590
0.042
Inadequate HDL-c (<40 mg/dL in male and <50 mg/dL in female), odds
ratios (OR) and 95% confidence intervals (CI95% ). Calories, dietary fiber, fats,
and saturated fats are presented in tertiles.
Acknowledgments
This study was supported by a research grant from the Mexico
National Science and Technology Council (Consejo Nacional
de Ciencia y Tecnologa, CONACYT) no. SALUD-2012-01181015.
References
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[27] P. M. Clifton, K. Bastiaans, and J. B. Keogh, High protein diets
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1232
Research Center of Nutrition and Food Safety, Chongqing Key Laboratory of Nutrition and Food Safety;
Departments of 2Endocrinology and 3Nutrition, Xinqiao Hospital, The Third Military Medical University,
Shapingba, Chongqing 400038, P.R. China
Received February 21, 2015; Accepted April 1, 2016
DOI: 10.3892/etm.2016.3377
Abstract. Soluble dietary fiber (DF) reduces the risk of developing diabetes and may have therapeutic effects in patients
with type 2 diabetes mellitus (DM2). The present study aimed
to investigate the effect of soluble DF on metabolic control in
patients with DM2. A total of 117 patients with DM2 between
the ages of 40 and 70 were assessed. Patients were randomly
assigned to one of two groups, and administered extra soluble
DF (10 or 20 g/day), or to a control group (0 g/day) for one
month. Blood glucose, serum insulin and connecting peptide
(Cpeptide) levels, and the insulin resistance index, as determined using the homeostatic model assessment method, were
measured during fasting and up to 2h postprandially prior to
and following one month of treatment. Other measurements
included serum levels of glycated albumin (GA), blood lipid
profiles, and an analysis of the blood pressure, body weight
and waist/hip ratio of all patients. Following intervention, the
levels of 2h blood glucose, fasting insulin and lipoprotein(a),
and the insulin resistance index, were significantly improved
in all groups. Furthermore, the fasting blood glucose, 2h
insulin, fasting Cpeptide, 2h Cpeptide, GA and triglyceride
(TG) levels were significantly improved in the soluble DF
Contributed equally
1233
1234
2326.40759.24
75.2434.34
13.563.58
118.8482.42
38.2314.56
254.7184.62
48.2114.40
14.589.38
502.55334.87
555.61179.60
1.340.54
0.900.42
79.6758.10
27.8017.80
18.0010.00
1805.80970.24
488.07441.22
367.59174.58
304.84198.87
19.718.40
4.922.48
12.214.74
1.901.21
46.5925.64
1076.22521.14
1701.80246.65a
62.3315.27b
14.042.16
59.9017.77a
24.002.86a
227.4042.36b
61.963.92a
14.254.53
221.1769.84a
608.81162.05
1.150.60
0.850.48
120.62117.32
42.9719.02
14.808.83
1879.441318.64
397.91203.13
409.55228.40
323.58227.09
18.939.98
5.052.46
11.024.54
1.991.22
36.2117.57
1031.75490.89
Control (n=37)
----------------------------------------------------------------Baseline
1 month
2232.71823.95
75.6631.97
14.153.46
83.6057.51
34.7113.27
270.1088.94
51.1412.86
15.689.37
450.67323.85
542.95151.30
1.200.59
0.870.33
108.4372.80
17.4710.21
15.318.56
2122.181424.78
441.47181.95
440.87220.15
346.87255.97
19.6010.14
5.382.83
11.613.99
2.181.28
39.2914.17
1070.40421.21
1724.86240.46a
65.1315.94a
15.382.84
62.5214.08b
23.972.89a
241.7454.76b
60.654.21a
24.924.67a,c
232.4663.01a
611.25173.07
1.420.66
0.980.66
171.38180.15
31.6023.36
18.049.01
2333.631357.68
554.97464.17
451.23293.72
383.31217.49
21.478.89
5.962.82
12.655.68
2.331.31
41.4819.05
1170.73540.84
10DF (n=40)
-----------------------------------------------------------------Baseline
1 month
2371.13994.31
87.1245.25
14.243.47
97.8059.78
36.2510.83
290.69119.85
49.5112.68
17.369.17
621.61523.25
655.85143.65
1.440.66
1.030.51
145.30100.08c
36.4923.46
17.608.66
2404.961197.49
645.86418.65
538.83296.37
380.53196.12
24.049.96
6.392.54
13.255.42
2.451.18
52.4037.41
1266.12530.88
1799.37295.76a
67.3515.80a
14.872.58
68.6415.92a
24.252.67a
252.8070.41b
60.883.47a
35.884.57a,c
227.8763.62a
618.54151.42
1.510.91
1.170.78
144.47129.14
38.3220.57
16.449.80
2646.091004.37
563.97400.39
584.43442.31
439.85284.76
24.5214.86
7.314.32
13.647.12
2.681.64
41.5320.29
1382.31791.55
20DF (n=40)
--------------------------------------------------------------------Baseline
1 month
Data are presented as the meanstandard deviation. aP<0.01 and bP<0.05, vs. the baseline; cP<0.01 vs. the control group. 10DF, 10g/day dietary fiber; 20DF, 20g/day dietary fiber; Vit, vitamin.
Energy (kcal/day)
Protein (g/day)
(% of energy)
Fat (g/day)
(% of energy)
Carbohydrate (g/day)
(% of energy)
Dietary fiber (g/day)
Cholesterol (mg/day)
Vit A (mg/day)
Vit B1 (mg/day)
Vit B2 (mg/day)
Vit C (mg/day)
Vit E (mg/day)
Vit PP (mg/day)
K (mg/day)
Na (mg/day)
Ca (mg/day)
Mg (mg/day)
Fe (mg/day)
Mn (mg/day)
Zn (mg/day)
Cu (mg/day)
Se (mg/day)
P (mg/day)
Parameter
1235
1236
Control
10DF
20DF
Fvalue
37
51.526.47
14/23
69.608.50
25.652.62
90.508.10
100.907.71
0.900.06
128.4615.87
75.5410.72
8.122.78
12.554.39
9.557.06
23.7816.52
3.342.64
2.251.03
5.284.05
18.844.74
4.832.16
2.081.58
1.120.42
2.922.71
292.16258.47
1.120.27
1.420.36
6.003.68
64.0922.49
289.65104.52
40
53.639.37
15/25
65.3010.20
24.802.92
90.709.79
100.007.01
0.910.06
132.8517.29
79.5812.19
8.262.84
12.504.21
9.275.75
24.9423.20
3.402.59
2.781.57
6.574.20
20.004.31
4.841.17
2.682.68
1.270.41
2.450.74
311.38282.61
1.250.29
1.300.49
5.911.73
59.5820.60
304.8392.57
40
55.528.15
17/23
69.5013.00
25.323.96
91.3110.90
100.617.21
0.910.06
130.7515.53
79.1510.23
8.712.91
12.543.88
9.815.60
24.9614.72
3.922.77
2.591.39
6.153.01
20.645.35
5.071.31
2.402.68
1.360.71
2.900.80
313.15227.88
1.290.49
1.520.48
5.862.01
60.3615.28
296.7876.57
2.066
0.675
0.071
0.144
0.239
0.701
1.517
0.459
0.002
0.076
0.226
0.549
1.457
0.013
1.368
0.287
0.599
1.983
1.008
0.078
2.294
2.007
0.029
0.574
0.265
Pvalue
0.131
0.511
0.931
0.866
0.788
0.498
0.224
0.633
0.998
0.927
0.798
0.579
0.237
0.987
0.259
0.751
0.551
0.142
0.368
0.925
0.106
0.132
0.971
0.565
0.768
Data are presented as the mean standard deviation. 10DF, 10 g/day dietary fiber; 20DF, 20 g/day dietary fiber; M, male; F, female; BMI, body
mass index; HOMAIR, homeostatic model assessmentinsulin resistance; HDL, highdensity lipoprotein; LDL, lowdensity lipoprotein; Lpa,
lipoprotein(a); Apo, apolipoprotein.
1237
Table III. Anthropometric measures, lipid profile and type 2 diabetes mellitus biomarkers after 1 month of treatment.
Parameter
Group
Baseline
1 month
Weight (kg)
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
128.4615.87
132.8217.29
130.7515.53
75.5410.72
79.5812.2
79.1510.23
69.578.48
65.2610.20
69.4912.99
25.652.62
24.802.92
25.333.96
90.518.05
90.719.81
91.3110.96
100.957.69
100.067.05
100.587.04
0.900.06
0.910.06
0.910.06
8.122.78
8.262.84
8.712.91
12.554.39
12.504.20
12.543.88
9.557.06
9.275.75
9.815.60
23.7816.52
24.9423.20
24.9614.72
3.342.64
3.402.59
3.922.77
2.251.03
2.781.57
2.591.39
5.284.05
6.574.20
6.153.01
18.844.74
20.004.31
20.645.35
4.832.16
4.841.17
5.071.31
2.081.58
2.682.68
2.402.68
1.120.42
1.270.41
1.360.71
123.8614.07
127.9315.89
126.0015.85a
76.059.32
76.408.03
78.388.39
67.278.29b
63.509.56a
68.0312.52
24.832.83a
24.162.82a
24.753.42
89.957.29
88.188.24b
91.039.41
99.086.86a
97.607.10b
100.247.14
0.910.05
0.900.06
0.910.06
7.672.87
7.262.94a
6.131.18b
11.274.75a
9.733.81b
8.082.77b
7.435.23a
7.244.72a
7.774.17b
20.7215.92a
19.7211.02b
21.3711.86b
2.562.17b
2.301.58b
2.121.29b
1.940.96
1.930.79b
1.960.78b
4.282.65
3.591.78b
3.272.03b
17.614.35
15.273.81b
12.611.92b
4.811.01
4.931.02
4.971.10
2.452.80
1.771.96b
1.551.21b
1.020.33
1.180.40
1.120.27a
1.779
1.968
2.232
0.375
1.894
0.517
2.841
2.656
1.325
2.715
2.535
1.343
0.677
2.822
0.088
2.373
3.199
0.255
1.211
0.240
0.448
1.162
2.684
5.957
2.667
4.409
7.721
2.729
2.371
2.819
2.446
3.435
4.704
3.794
3.182
4.678
1.856
3.893
3.212
2.008
2.979
1.869
1.859
7.361
8.948
0.039
0.801
0.463
1.019
2.891
3.177
1.457
1.896
2.359
BMI (kg/m2)
Waist/hip ratio
2h insulin (mU/l)
HOMAIR
2h Cpeptide (ng/ml)
Cholesterol (mmol/l)
Triglyceride (mmol/l)
HDL (mmol/l)
Pvalue
0.084
0.056
0.031
0.710
0.066
0.608
0.007
0.012
0.193
0.010
0.015
0.187
0.502
0.007
0.930
0.023
0.003
0.800
0.234
0.812
0.657
0.253
0.011
<0.001
0.011
<0.001
<0.001
0.010
0.023
0.008
0.019
0.001
<0.001
0.001
0.003
<0.001
0.072
<0.001
0.003
0.052
0.005
0.004
0.071
<0.001
<0.001
0.969
0.428
0.646
0.315
0.006
0.003
0.154
0.065
0.023
1238
Group
Baseline
1 month
LDL (mmol/l)
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
2.922.71
2.450.74
2.900.80
292.16258.47
311.38282.61
313.15227.88
1.120.27
1.250.29
1.290.49
1.020.36
1.300.49
1.520.48
2.761.62
2.320.61
2.310.76b
378.35315.53b
371.38207.30a
362.60186.65b
1.040.17
1.190.26
1.200.23
0.950.42
1.160.59
1.180.35b
0.452
1.348
4.683
4.210
2.581
3.126
2.013
1.315
1.165
1.842
1.572
3.627
Lpa (mg/l)
ApoA (g/l)
ApoB (g/l)
Pvalue
0.654
0.185
<0.001
<0.001
0.014
0.003
0.052
0.196
0.251
0.074
0.124
0.001
Data are presented as the mean standard deviation. Significant Pvalues (P<0.05) are indicated in bold. aP<0.05 and bP<0.01 vs. the baseline.
10DF, 10 g/day dietary fiber; 20DF, 20 g/day dietary fiber; BMI, body mass index; HOMAIR, homeostatic model assessmentinsulin resistance; HDL, highdensity lipoprotein; LDL, lowdensity lipoprotein; Lpa, lipoprotein(a); Apo, apolipoprotein.
Table IV. Comparison of the statistical differences between the pre and posttreatment measurements of various parameters
among the three groups.
Parameter
Weight (kg)
BMI (kg/m2)
Waist circumference (cm)
Hip circumference (cm)
Waist/hip ratio
Systolic pressure (mmHg)
Diastolic pressure (mmHg)
Fasting blood glucose (mmol/l)
2 h blood glucose (mmol/l)
Fasting insulin (mU/l)
2 h insulin (mU/l)
HOMAIR
Fasting Cpeptide (ng/ml)
2 h Cpeptide (ng/ml)
Glycated albumin (%)
Cholesterol (mmol/l)
Triglyceride (mmol/l)
HDL (mmol/l)
LDL (mmol/l)
Lpa (mg/l)
ApoA (g/l)
ApoB (g/l)
Urea nitrogen (mmol/l)
Creatinine (mol/l)
Uric acid (mol/l)
Control
10DF
2.304.92
0.821.84
0.575.10
1.864.78
0.010.05
4.5915.71
0.518.34
0.452.36
1.292.94
2.114.71
3.077.62
0.791.26
0.321.05
1.003.04
1.234.03
0.011.80
0.372.19
0.100.41
0.162.15
86.19124.52
0.070.22
0.070.24
0.603.34
1.9417.60
3.9277.67
1.764.20
0.651.62
2.545.69
2.464.87
0.000.05
4.9315.83
3.1810.60
1.002.36
2.773.97d
2.045.43
5.229.61
1.112.20
0.851.37
1.994.22
4.734.06
0.100.76
0.911.98
0.090.30
0.130.61
60.00147.05
0.060.30d
0.140.57
0.411.75
2.3210.34
10.7065.16
20DF
P1
1.477.02
0.659
0.582.72
0.877
0.096.44a
0.051
0.215.09a
0.074
0.000.06
0.738
4.7513.46
0.833
0.789.48
0.399
2.582.74b,c <0.001
4.463.65a,b <0.001
2.044.58
0.941
4.696.31
0.514
1.802.44d
0.081
0.621.23
0.684
0.882.97
0.127
b,c
8.755.39
<0.001
0.931.32
0.848
0.841.69b
0.008
0.240.65
0.251
0.580.79d
0.091
49.45100.06 0.436
0.090.47d
0.028
0.340.59
0.609
0.411.79
0.921
1.6411.07
0.527
1.4379.87
0.802
P2
0.865
0.901
0.095
0.428
0.444
0.546
0.405
0.303
0.033
0.937
0.250
0.344
0.386
0.989
<0.001
0.570
0.008
0.818
0.195
0.368
0.021
0.344
0.692
0.291
0.599
P3
0.496
0.720
0.493
0.150
0.781
0.747
0.639
<0.001
<0.001
0.803
0.519
0.026
0.690
0.085
<0.001
0.723
0.005
0.129
0.030
0.210
0.018
0.776
0.781
0.371
0.943
P4
0.391
0.622
0.018
0.025
0.625
0.772
0.181
0.004
0.016
0.738
0.605
0.186
0.627
0.076
<0.001
0.828
0.861
0.187
0.368
0.717
0.922
0.506
0.904
0.868
0.541
Data are presented as the mean standard deviation. Significant Pvalues (P<0.05) are indicated in bold. aP<0.05 vs. the 10DF group; bP<0.01 vs.
the control group; cP<0.01 vs. the 10DF group; dP<0.05 vs. the control group. P1, analysis of variance among the three groups; P2, comparison
between the 10DF and control groups; P3, comparison between the 20DF and control groups; P4, comparison between the 10DF and 20DF
groups; 10DF, 10 g/day dietary fiber; 20DG, 20 g/day dietary fiber; BMI, body mass index; HOMAIR, homeostatic model assessmentinsulin
resistance; HDL, highdensity lipoprotein; LDL, lowdensity lipoprotein; Lpa, lipoprotein(a); Apo, apolipoprotein.
1239
Group
Baseline
1 month
Pvalue
Control
10DF
20DF
Control
10DF
20DF
Control
10DF
20DF
6.003.68
5.911.73
5.862.01
64.0922.49
59.5820.60
60.3615.28
289.65104.52
304.8392.57
296.7776.57
5.401.49
5.501.44
5.451.53
62.1518.73
61.9119.99
62.0015.42
293.5788.28
294.1371.33
298.2067.34
1.093
1.468
1.438
0.670
1.421
0.937
0.307
1.039
0.113
0.282
0.150
0.158
0.507
0.163
0.354
0.761
0.305
0.911
Creatinine (mol/l)
Data are presented as the mean standard deviation. 10DF, 10 g/day dietary fiber; 20DF, 20 g/day dietary fiber.
Group
Control
10DF
20DF
Pvalue
5.272.33
5.402.35
5.252.42
0.954
1.221.10
1.351.60
1.181.04
0.752
1.491.04
1.451.04
1.481.01
0.987
5.272.16
6.331.00a,b
6.451.22a,b
0.002c
1.221.08
0.500.60a,b
0.550.64a,b
<0.001c
1.451.04
0.650.77a,b
0.630.68a,b
<0.001c
Data are presented as the mean standard deviation. aP<0.05 vs. the control group; bP<0.05 vs. the baseline; cP<0.05; analysis of variance
among the three groups. 10DF, 10 g/day dietary fiber; 20DF, 20 g/day dietary fiber.
1240
1241
1242
Abstract
Background: Dietary factors play an important role in glycemic control in diabetic patients. However, little is known about
their effects among Chinese diabetic patients, whose diets are typically abundant in fiber and high in glycemic index (GI)
values.
Methodology/Principal Findings: 934 patients with type 2 diabetes and 918 healthy volunteers from Pudong New Area,
Shanghai, China, were interviewed during the period of Oct-Dec, 2006 to elicit demographic characteristics and lifestyle
factors. Dietary habits were assessed using a validated food frequency questionnaire. Anthropometric measurements, biospecimen collection and biochemical assays were conducted at the interview according to a standard protocol. In this
population, diabetic patients consumed lower levels of energy and macronutrients but had higher levels of fasting plasma
glucose (FPG), glycolated hemoglobin A1c (HbA1c), triglyceride and body mass index than healthy adults. While the average
consumption levels of the nutrients among diabetic patients did not vary along duration of the disease, the average levels
of FPG and HbA1c increased with increasing duration. Regardless of diabetes duration, HbA1c level was observed lower in
patients having a higher fiber or lower GI intake. Compared with those with the lowest tertile intake of fiber, the adjusted
odds ratios (ORs) for poor glycemic control reduced from 0.75 (95%CI: 0.541.06) to 0.51 (95%CI: 0.340.75) with increasing
tertile intake (P for trend ,0.001).
Conclusions: Dietary fiber may play an important role in reducing HbA1c level. Increasing fiber intake may be an effective
approach to improve glycemic control among Chinese diabetic patients.
Citation: Jiang J, Qiu H, Zhao G, Zhou Y, Zhang Z, et al. (2012) Dietary Fiber Intake Is Associated with HbA1c Level among Prevalent Patients with Type 2 Diabetes
in Pudong New Area of Shanghai, China. PLoS ONE 7(10): e46552. doi:10.1371/journal.pone.0046552
Editor: Noel Christopher Barengo, Fundacion para la Prevencion y el Control de las Enfermedades Cronicas No Transmisibles en America Latina (FunPRECAL),
Argentina
Received March 13, 2012; Accepted September 5, 2012; Published October 16, 2012
Copyright: ! 2012 Jiang et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This research was funded by Shanghai Municipal Health Bureau (08GWZX0201) and Academic Leaders Training Program of Pudong Health Bureau of
Shanghai (Grant No. PWRd2010-03). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: The authors have declared that no competing interests exist.
* E-mail: wanghong.xu@fudan.edu.cn (WX); ruan_118@hotmail.com (XR)
Introduction
Type 2 diabetes is an important risk factor for micro-vascular
and macro-vascular complications. Effective control of hyperglycemia, dyslipidemia and hypertension, either by medication or by
lifestyle intervention, is crucial to decrease the incidence of stroke,
myocardial infarction and renal disease, as well as the related
premature death [1,2]. Intervention studies have examined the
impact of dietary intake on glycemic control, and found that
higher intake of dietary fiber [3,4] and lower intakes of dietary fat
[5], glycemic index (GI) [6] and carbohydrate [7] improved
glycemic control status. In the Nurses Health Study, He, et al [8]
observed a potential benefit of whole grain, cereal fiber and bran
intake in reducing mortality and cardiovascular risk in diabetic
patients. None of these studies, however, were conducted in
Chinese population.
Data collection
A structured in-person interview was conducted for each subject
by trained interviewers to collect information on demographic
characteristics, duration of diabetes, age at onset of diabetes,
diagnosis of hypertension, presence of dyslipidemia, use of tobacco
and alcohol. Presence of hypertension, dyslipidemia and coronary
heart disease were defined by a positive response to the question of
Have you ever been diagnosed with hypertension/dyslipidemia/
coronary heart disease by a doctor?. Family history of diabetes
was defined as positive if any first- or second-degree relative had
type 2 diabetes. Smoking was defined as at least 1 cigarette per day
for at least 6 months, and alcohol use was defined as drinking
alcohol at least 3 times a week for more than 6 months.
Dietary habit was assessed using an interviewer-administered
food frequency questionnaire (FFQ) modified based on a validated
FFQ [13]. The FFQ specifies 103 food items, covering 90% of
food items commonly consumed in Shanghai. For each food item,
participants were asked to report how frequently (daily, weekly,
monthly, annually or never) and how long (months per year) they
consumed the food, followed by a question on the amount of
consumption in liang (1 liang = 50 g) per unit of time in previous 12
months. For liquid foods such as milk, juice and beverage, the
amount of intake was reported in milliliter (ml) and was
transformed into gram in the analysis. The daily intakes of oil,
salt and sugar were calculated as the average level consumed by
each family member of the participant.
Nutrient content from the Chinese Food Composition Tables
was applied to estimate nutrient intake from all food items and
groups, and to obtain GI values for most food items [14]. For the
remaining food items, we referenced Foster-Powell et als report to
obtain their GI values [15]. Glycemic load (GL) from each food
was calculated by multiplying the foods GI value by the
carbohydrate content of the food and the average amount of the
food consumed per day. Total dietary GL was then produced by
summing these products over all food items. Dietary GI was
derived by dividing the dietary GL by the amount of carbohydrate
intake, thus yielding a weighted average GI for each individuals
PLOS ONE | www.plosone.org
Statistical analysis
Statistical analyses were conducted utilizing SAS statistical
software 9.2 (SAS Institute Inc., Cary, NC). Differences on
demographic factors by diabetic status or glycemic control status
were evaluated using x2 test for categorical variables or nonparameter Wilcoxon test for continuous variables. Partial correlation analysis was conducted to evaluate the linear correlations of
HbA1c levels with amounts of dietary intake. A generalized linear
regression model was applied to compare the average levels of
biochemical measurements and average levels of dietary intake.
An unconditional logistic regression model was employed to
estimate the adjusted odds ratios (ORs) and 95% confident
intervals (CIs) of dietary intake with glycemic control status among
diabetic patients. Natural log transformation was applied to
normalize the distribution of biochemical measurements before
parametric methods were used in data analysis. All statistical tests
were based on two-sided probability.
Results
Compared with the recruited healthy volunteers, diabetic
patients were older and less educated, had more family history
of diabetes and higher prevalence of hypertension, dyslipidemia
and coronary heart disease (CHD), as shown in Table 1. Among
934 prevalent diabetic patients, 488 (52.3%) had an HbA1c level
of $7.0%. These patients, compared with those having an HbA1c
level of ,7.0%, appeared to have less education, younger age at
diagnosis of diabetes, longer duration of diabetes, lower prevalence
of hypertension and were more likely to use oral hypoglycemia
drug and insulin. No significant difference was observed between
the two groups with regard to age, sex, smoking, alcohol
Characteristics
Healthy adults
(N = 918)
Diabetic patients
(N = 934)
P value
Diabetic patients
P valuea
HbA1c,7.0% (N = 446)
HbA1c$7.0% (N = 488)
57.7 (9.9)
64.5 (10.1)
,0.001
64.6 (10.1)
64.4 (10.1)
0.825
291 (31.7)
389 (41.7)
,0.001
191 (42.8)
198 (40.6)
0.487
864 (92.5)
0.008
400 (89.9)
465 (94.9)
0.004
88 (9.6)
298 (31.9)
,0.001
130 (29.2)
168 (34.4)
0.084
55.2 (10.4)
56.4 (10.4)
54.2 (10.0)
0.002
9.2 (6.4)
8.2 (6.3)
10.2 (6.3)
,0.001
518 (55.5)
,0.001
265 (59.4)
253 (51.8)
0.020
97 (10.4)
0.004
55 (12.3)
42 (8.6)
0.062
132 (14.1)
,0.001
73 (16.4)
59 (12.1)
0.061
46 (5.0)
134 (46.1)
152 (39.1)
0.068
70 (36.7)
82 (41.4)
0.336
Women
6 (1.0)
5 (0.9)
0.944
2 (0.8)
3 (1.0)
1.000
113 (33.8)
108 (27.8)
0.002
49 (25.7)
59 (29.8)
0.362
Women
21 (3.4)
10 (1.8)
0.108
5 (2.0)
5 (1.7)
1.000
762 (81.5)
341(76.5)
421(87.0)
,0.001
88 (9.4)
31(7.0)
57(11.8)
0.012
Missing values (1 for age, education, diagnosis age of DM, duration of DM in diabetic patients; 1 for current alcohol consumption in healthy adults; 4 for oral
hypoglycemic drug use and insulin use) were excluded;
a 2
x test for categorical variables or non parameter Wilcoxon test for continuous variables.
doi:10.1371/journal.pone.0046552.t001
Discussion
In this cross-sectional study including 934 Chinese prevalent
patients with type 2 diabetes from Pudong New Area of Shanghai,
China, we observed a stable after-diagnosis dietary habit, upward
trend of HbA1c level along with duration of diabetes, a lower
average level of HbA1c related with higher fiber intake, and a
probably protective effect of dietary fiber on glycemic control
status. Our findings have several implications in improving
Table 2. Average levels of dietary intake by diabetic status and duration of type 2 diabetes.
Diabetic
Healthy adults patients
(N = 918)
(N = 934)
P valueb
59 (N = 316)
$10 (N = 387)
P valuec
Men
Energy, kcal/d
1931.2 (1.4)
1644.1 (1.3)
,0.001
1740.8 (1.3)
1600.0 (1.3)
1615.5 (1.3)
0.225
Carbohydrate, g/d
323.6 (1.4)
268.2 (1.3)
0.003
282.5 (1.3)
263.9 (1.3)
261.6 (1.3)
0.583
Protein, g/d
68.9 (1.4)
61.5 (1.5)
0.003
65.1 (1.5)
58.3 (1.4)
62.0 (1.4)
0.467
Fiber, g/d
10.2 (1.6)
9.2 (1.7)
0.232
9.9 (1.6)
8.4 (1.6)
9.6 (1.7)
0.045
Fat, g/d
40.9 (1.6)
37.1 (1.6)
0.002
40.0 (1.5)
35.3 (1.6)
36.9 (1.6)
0.485
Average GI
61.5 (1.1)
60.4 (1.2)
0.323
61.0 (1.2)
61.4 (1.1)
59.2 (1.2)
0.230
Average GL
104.7 (1.4)
87.6 (1.4)
0.347
93.3 (1.4)
84.0 (1.4)
86.5 (1.4)
0.670
Energy, kcal/d
1695.2 (1.3)
1410.5 (1.3)
,0.001
1445.2 (1.4)
1438.3 (1.4)
1367.4 (1.3)
0.438
Carbohydrate, g/d
279.2 (1.3)
226.3 (1.4)
,0.001
234.0 (1.4)
231.4 (1.4)
217.9 (1.4)
0.878
Protein, g/d
61.8 (1.4)
52.9 (1.5)
,0.001
54.3 (1.5)
53.7 (1.5)
51.2 (1.5)
0.973
Fiber, g/d
10.2 (1.6)
8.5 (1.7)
0.460
8.8 (1.7)
8.4 (1.7)
8.3 (1.7)
0.868
Fat, g/d
38.4 (1.6)
33.4 (1.6)
,0.001
33.5 (1.6)
33.8 (1.7)
32.9 (1.5)
0.797
Average GI
59.9 (1.1)
59.2 (1.2)
,0.001
59.3 (1.1)
59.6 (1.2)
58.7 (1.2)
0.733
Average GL
92.1 (1.4)
74.2 (1.4)
,0.001
76.8 (1.4)
75.7 (1.4)
71.5 (1.4)
0.783
Women
Continuous variables were all natural LOG transformed before entering models;
Generalized linear model adjusting for age, BMI and energy intake;
c
Generalized linear model adjusting for age, BMI, oral hypoglycemic drug use, insulin use and energy intake.
doi:10.1371/journal.pone.0046552.t002
b
Table 3. Average levels of metabolic indicators by diabetic status and duration of type 2 diabetes.
Diabetic
Healthy adultspatients
P valueb
P valuec
,5 (N = 230)
59 (N = 316) .9 (N = 387)
,0.001
7.2 (1.3)
8.1 (1.4)
8.5 (1.4)
,0.001
,0.001
6.9 (1.2)
7.4 (1.2)
7.7 (1.2)
,0.001
4.4 (1.2)
0.003
4.4 (1.2)
4.4 (1.2)
4.4 (1.2)
0.733
1.3 (1.7)
1.4 (1.8)
,0.001
1.5 (1.8)
1.4 (1.7)
1.4 (1.8)
0.508
2.8 (1.3)
2.7 (1.4)
,0.001
2.7 (1.4)
2.7 (1.3)
2.7 (1.4)
0.177
(N = 918)
(N = 934)
FPG, mmol/L
5.3 (1.2)
8.0 (1.4)
HbA1c (%)
5.9 (1.1)
7.4 (1.2)
TC, mmol/L
4.5 (1.2)
TG, mmol/L
LDLC, mmol/L
HDLC, mmol/L
Men
1.1 (1.3)
1.1 (1.2)
0.998
1.1 (1.2)
1.1 (1.1)
1.2 (1.1)
0.111
Women
1.3 (1.3)
1.3 (1.3)
0.224
1.3 (1.3)
1.3 (1.2)
1.3 (1.3)
0.266
24.8 (1.1)
25.6 (1.1)
0.005
25.8 (1.2)
25.7 (1.1)
24.8 (1.1)
0.002
BMI
a
Continuous variables were all natural LOG transformed before entering models;
Generalized linear model adjusting for age and gender;
Generalized linear model adjusting for age, gender, oral hypoglycemic drug use and insulin use.
doi:10.1371/journal.pone.0046552.t003
b
c
Figure 1. Average levels of HbA1c by duration of type 2 diabetes and dietary fiber or GI intake. The low and high fiber or GI intakes were
classified by the medians of consumption in men and women, respectively. Means of HbA1c level were adjusted for age (as a continuous variable),
sex (male/female), duration of type 2 diabetes (as a continuous variable), BMI (as a continuous variable), oral hypoglycemic drug use (yes/no), insulin
use (yes/no) and energy intake (as a continuous variable).
doi:10.1371/journal.pone.0046552.g001
Table 4. Associations of dietary intake with glycemic control status among diabetic patients.
Dietary intakea
HbA1c, % (Mean,
Glycemic control status, N (%)
SD)
Controlled (HbA1c,7.0%)
OR (95%CI)b
P for trend
Uncontrolled (HbA1c$7.0%)
Energy (kcal/d)
Low
7.5 (1.4)
143 (32.2)
165 (34.2)
1.00
Medium
7.6 (1.7)
139 (31.3)
170 (35.3)
High
7.5 (1.7)
162 (36.5)
147 (30.5)
Low
7.6 (1.5)
137 (30.9)
171 (35.5)
1.00
Medium
7.5 (1.6)
147 (33.1)
163 (33.8)
High
7.5 (1.8)
160 (36.0)
148 (30.7)
0.300
Carbohydrate (g/d)
0.166
Protein (g/d)
Low
7.6 (1.5)
135 (30.4)
172 (35.7)
1.00
Medium
7.5 (1.6)
151 (34.0)
159 (33.0)
High
7.5 (1.8)
158 (35.6)
151 (31.3)
0.052
Fiber (g/d)
Low
7.7 (1.5)
126 (28.4)
182 (37.8)
1.00
Medium
7.5 (1.5)
148 (33.3)
162 (33.6)
High
7.4 (1.8)
170 (38.3)
138 (28.6)
,0.001
Fat (g/d)
Low
7.5 (1.5)
139 (31.3)
168 (34.9)
1.00
Medium
7.4 (1.6)
167 (37.6)
144 (29.9)
High
7.7 (1.8)
138 (31.1)
170 (35.3)
0.630
Average GI
Low
7.5 (1.6)
145 (32.7)
163 (33.8)
1.00
Medium
7.4 (1.7)
165 (37.2)
144 (29.9)
High
7.7 (1.6)
134 (30.2)
175 (36.3)
0.184
Average GL
Low
7.6 (1.6)
141 (31.8)
166 (34.4)
1.00
Medium
7.6 (1.6)
139 (31.3)
172 (35.7)
High
7.5 (1.7)
164 (36.9)
144 (29.9)
0.154
a
Dietary factors were classified as low, medium and high intake by the tertiles in men and in women, respectively. The cut points for energy intake were 1444.06 and
1842.84 kcal/d in men and 1268.88 and 1623.31 kcal/d in women; for carbohydrate were 248.93 and 295.77 g/d in men and 205.85 and 267.65 g/d in women; for
protein intake were 50.89 and 72.42 g/d in men and 44.88 and 62.71 g/d in women; for fiber intake were 7.12 and 11.32 g/d in men and 6.73 and 10.51 g/d in women;
for fat were 31.02 and 44.62 g/d in men and 28.74 and 40.61 g/d in women; for average GI were 56.53 and 64.58 units/d in men and 55.88 and 62.95 units/d in women;
for average GL were 65.57 and 99.67 units/d in men and 76.34 and 87.55units/d in women.
b
OR, odds ratio; 95%CI, 95% confidence interval; OR: adjusted for age (as a continuous variable), sex (male/female), duration of type 2 diabetes (as a continuous
variable), BMI (as a continuous variable), oral hypoglycemic drug use (yes/no), insulin use (yes/no) and energy intake (as a continuous variable).
doi:10.1371/journal.pone.0046552.t004
Acknowledgments
Author Contributions
The authors are grateful to the study participants and research staff from
Community Health Centers in Pudong New Area of Shanghai, China.
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