Supplemen

tary

Table

1dCom

parisonof

stud

ydesign

andresults

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

Carbo

hyd

rate

amou

nt:lower

carboh

ydrate

(10)

Boden

2005

Clin

icaltrial,

singlearm/

14day

Typ

e2

10adults

Low-CHO

diet

21gCHO/day

A1C

decreased0.5%

(P5

0.00

6);m

ean

24-h

plasmaglucose

andinsulin

decreased

(P5

0.00

2and

P5

0.03

9,respectively);FB

Gdecreasedfrom

7.5to

6.3mmol/L

(P5

0.02

5).Insulin

sensitivity

(by

euglycem

ic-

hyperinsulin

emic

clam

p)im

proved

by75

%.

TCdecreasedfrom

4.68

to4.24

mmol/L

(P5

0.02

);TG

decreasedfrom

1.84

to1.19

mmol/L

(P,

0.00

01).

Metabolic-unit–type

stud

ySign

ificant

weightloss

(11)

Daly20

06RCTparallel,

2arms/3mon

ths,

multicenter

Typ

e2

79adults

Low-CHO

dietvs.

low-fatdiet

Low-CHO

diet:

goalof

upto

70gCHO/day

(achieved11

0g/day)vs.low

-fatdiet:stand

ard

advice

toreduce

portions

andfat

(achieved16

9g

CHO/day)

Glycemicmeasures:NS

TC:HDL-Cratio

improvedin

low-

CHO

grou

pvs.

low-fatgrou

p(2

0.48

vs.2

0.10

,P5

0.01

1)

77%

completionrate

Weight-loss

stud

y

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 1

S Y S T E M A T I C R E V I E W

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(12)

Davis20

09RCTparallel,

2arms/1year

Typ

e2

85adults

Lower-CHO

diet

(Atkinstype)

vs.

lower-fatdiet

(DPP

type)

Low-CHO

diet:

initialgoalo

f20

–25

gCHO/

day,increased

by5-gincrem

ents

each

weekas

participantslost

weight(achieved

33.4%

CHO,

43.9%

fat)vs.

low-fatdiet:goalo

f25

%fat(achieved

30.8%

fat,50

.1%

CHO).50

0kcal/

daydeficitfor

both

arms

Glycemicmeasures:NS

HDL-Cincreased

moreat6mon

ths

inthelow-CHO

grou

p(1

0.16

mg/dL

,P5

0.00

2)and

increase

was

sustainedat

12mon

ths

Weight-loss

stud

y(bothgrou

ps

achieved

a3.4%

weightreduction

)Su

bjectsun

der

good

controlat

baselin

e(A1C

7.4–

7.5%

)

(13)

Dyson

2007

RCTparallel,

2arms/3mon

thsTyp

e2

12adultswith

diabetes

(22total)

Low-CHO

dietvs.

healthyeatin

g(DiabetesUK

nutrition

recommendation

s),

calorie-restricted

diet

Low-CHO

diet:

#40

gCHO/day

(achieved57

gCHO/day)vs.

“healthy

eatin

g”with50

0kcal/day

energy

deficit

(achieved16

7g

CHO/day)

Glycemicmeasures:NS

CVDrisk

measures:NS

Weight-loss

stud

y

2 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(14)

Yancy20

05Clin

icaltrial,

singlearm/

16weeks

Typ

e2

21adults

Low-CHO

diet

InitialC

HO

goalof

,20

gCHO/day,

increasingCHO

by5g/day

each

weekaftersome

weightloss(8

subjectswith

adequatefood

recordsachieved

34gCHO/day

atweek16

)

A1C

decreasedby

16%

from

7.5to

6.3%

(P,

0.00

1)TGdecreased42

%from

2.69

to1.57

mmol/L

(P5

0.00

1)

75%

retentio

nrate

20of

the21

participants

weremen

Weight-loss

stud

yDiabetesmedications

werediscon

tinu

edin

7participants,

redu

cedin

10participants

(15)

Stern20

04RCTparallel,

2arms/1year

Mainlytype2

34adultswith

diabetes

(87total)

Low-CHO

dietvs.

lower-fat(N

HLB

Igu

idelines)

calorie-restricted

diet

LowCHO:,

30g

CHO/day

(achieved12

0g

CHO/day)vs.

convention

alweight-loss

diet:

restrictcalorie

intake

by50

0calories/day

with

,30

%fat

(achieved23

0g

CHO/day)

A1C

decreasedmore

inthelowCHO

grou

pwith

diabetes

(20.7%

)vs.the

calorie-restricted

grou

pwith

diabetes

(20.1%

)after

adjustmentfor

baselin

edifferences

andweigh

t-loss

amou

nt(P

50.01

9)CVDrisk

measures:

notprovided

for

diabetes

grou

pon

ly

Weight-loss

stud

y62

%retentio

nrateforpeop

lewithdiabetes

83%

ofsubjects

weremen

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 3

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(16)

Westm

an20

08RCTparallel,2

arms/6

mon

ths

Typ

e2

50adults

Low-CHO

dietvs.

low-G

I,reduced-calorie

diet

Low-CHO

diet:

goal,20

gCHO/day

(achieved49

g6

33gCHO/day)

vs.low

-GI,

reduced-calorie

diet(500

kcal/day

energy

deficit):

goal55

%CHO

(achieved44

%CHO)

A1C

reduced

1.5%

inlow-CHO

diet

vs.2

0.5%

inlow-GIdiet,P

50.03

HDL-Cincreased

by5.6mg/dL

inlow-CHO

diet

vs.n

ochange

inlow-GIdiet,

P,

0.05

58%

retentio

nrate

Weight-loss

stud

y“Low

GI”no

tdefined

(17)

Haimoto

2009

Clin

icaltrial,

singlearm/6

mon

ths

Typ

e2

31adults

Lower-CHO

diet

Lower-CHO

goal:

30%

CHO,4

4%fat,20

%protein;

achieved:

306

10%

CHO,

446

10%

fat,

206

4%protein

A1C

decreased

from

10.9

to7.4%

(P,

0.00

1)LD

L-Cdecreased

from

142to

128mg/dL

(P5

0.03

6);H

DL-C

increasedfrom

52to

59mg/dL

(P5

0.00

8)

Weight-loss

stud

y

(18)

Miyashita

2004

RCTparallel,2

arms/4

weeks

Typ

e2

22adults

Lower-CHO

dietvs.

higher-CHO

diet

Lower-CHO

diet:

39%

CHO,3

5%fat,25

%protein

vs.h

igher-CHO

diet:6

2%CHO,

10%

fat,26

%protein

Fastinginsulin

decreased30

%in

lower

CHO

vs.

10%

inhigh

erCHO

(P,

0.05

)HDL-Cincreased

15%

inlower

CHO

vs.0

inhigh

erCHO

( P,

0.01

)

Metabolic-unitstud

yWeight-loss

stud

y:weightdeclined

similarlyin

both

grou

ps:lower

CHO,

73→64

kg;h

igher

CHO,7

1→64

kgFibersimilarin

both

diets

4 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(19)

Wolever

2008

RCTparallel,3

arms/1-year

multicenter

stud

y

Typ

e2

130adults

HigherGIvs.low

erGIvs.low

erCHO/high

MUFA

End

ofstud

y:high

erGI:

46.5%

CHO,

30.8%

fat,

12.3%

MUFA,

20.4%

protein,

GI5

63%,G

L535

gvs.low

erGI:52

%CHO,

26.5%

fat,10

.7%

MUFA,2

0.6%

protein,

GI5

55%,G

L5

133gvs.low

erCHO:3

9.3%

CHO,4

0%fat,

18.3%

MUFA,

19%

protein,

GI5

59%,G

L5

110g

Glycemicmeasures:NS

HDL-C4%

lower

andTG12

%high

eron

lower-G

Idiet

than

lower-CHO

diet(P

,0.05

for

both);high

erGI

was

interm

ediate

Weightno

tcontrolled,

butbo

dyweightno

tsign

ificantly

differentamon

gdiets

Diabetescontrolled

bydietalon

eand

subjectswerein

optimalglycem

iccontrol

Key

food

sprovided

Lower-GIdiethad

30%

lower

CRPthan

thehigher

GI(P

50.00

78)

(20)

Jönsson

2009

RCTcrossover/3

mon

thseach

(nowasho

utperiod

)

Typ

e2

13adults

Tradition

aldiabetic

dietvs.P

aleolithic

diet

Traditio

nald

iet:

high

erfiber/

who

legrains,

lower

saturated

fatvs.P

aleolithic

diet:leanmeats,

fish,fruit,

vegetables,eggs,

nuts

A1C

lower,P

aleolithic

vs.tradition

aldiet:

5.5vs.5

.9%

(P5

0.02

)HDL-Chigh

erby

0.08

mmol/L,P

aleolithic

vs.tradition

al(P

50.03

)TGlower

by0.4mmol/L,

Paleolithicvs.

traditional(P5

0.00

3)

76%

completionrate

Weightno

tcontrolled

(BMIdecreased

sign

ificantly,

Paleolithicvs.

tradition

al)(P

50.04

)

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 5

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

Carbo

hyd

rate

amou

nt:mod

erateto

highcarboh

ydrate

(21)

Barnard

2009

RCTparallel,

2arms/74

weeks

Typ

e2

83adults

Lower-fatvegan

dietvs.

convention

al“

diabetes”diet

Vegan:

CHO

75→66

.3%

Fat10

→22

.3%

SFA5.1%

achieved

Protein15

→14

.8%

vs.

Con

vention

aldiet:

CHO60–70→46.5%

Fat3

3.7%

achieved

SFA,7→

9.9%

Protein15–20→21.1%

Glycemicmeasures:NS

CVDrisk

measures:NS

Ancillary

analysis

lastavailableor

observed

before

medication

adjustment:

A1C

20.40

and

0.01

%in

vegan

andconvention

aldiets,respectively

(P5

0.03

)TC220

.4and26.8

mg/dLin

thevegan

andconvention

aldietgrou

ps,

respectively

(P5

0.01

)LD

L-C213

.5and

23.4mg/dL

inthe

veganand

conv

ention

algrou

ps,respectively

(P5

0.03

)Weightreduction

ifoverweight;weigh

tcontrolledin

some

regression

analyses

6 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(22)

Gerhard

2004

RCTcrossover/6

weeks

each

with6–

12-

weekwasho

ut

period

Typ

e2

11adults

Lower-fatdiet

vs.h

igher-MUFA

diet

Lower-fatdiet:

CHO

65→64

.7%

Fat20

→20

.8%

MUFA8.3%

achieved

vs. Higher-MUFAdiet:

CHO

45→45

.1%

Fat40

→39

.6%

MUFA26

→25

.1%

Proteinconstant

forbo

thdiets

(15%

)

Glycemicmeasures:NS

CVDrisk

measures:NS

Mealsprepared

inmetabolickitchen

Bodyweigh

tdecreased

sign

ificantly

(21.53

kg,P

,0.00

1)on

lower-fat

diet

Onbo

thdiets,subjects

wereprovided

25%

abovemaintenance

energy

requ

irem

ent

(mean3,55

5kcal/

day)

toallowself-

selectionfor

quantity

(23)

Wycherley

2010

RCTparallel,

4arms/16

weeks

Typ

e2

59adults

Standard-CHO

dietvs.h

igh-

proteindiet

Stud

yhas4grou

ps:

StandardCHO:

CHO

53→53

.6%

Fat26

→22

.6%

Protein19

→18

.6%

vs.

Highprotein:

CHO

43→47

.4%

Fat22

→17

.7%

Protein33

→32

%Fo

rtheother

2grou

ps,resistance

exercise

training

was

addedto

each

diet.

Glycemicrespon

se:N

SCVDrisk

measures:NS

Weight-loss

stud

y,withbo

thdiets

energy

restricted

(;1,40

0kcal/day

forwom

en,

;1,70

0formen)

Key

food

swere

supp

lied(50%

totalenergy)

71%

completionrate

Significant

redu

ctions

inall

grou

psforweight,

A1C

,FBG

,TC,

LDL-C,andTG

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 7

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

numbe

rAuthor/

year

Studytype/

duration

Diabetes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(24)

Brinkw

orth

2004

RCTparallel,

2arms/

52-w

eekfollo

w-

upof

a12

-week

interventio

n

Type2

38adults

Higherproteinvs.

lower

protein

Higher-protein

goals:

40%

CHO,

30%

fat,

30%

proteinvs.

lower-protein

goals:

55%

CHO,

30%

fat,

15%

protein

Glycemicmeasures:NS

CVDrisk

measures:NS

SeeParker

2002

for

stud

yof

first8

weeks

Weigh

tun

controlled

58%

retention

rate

HDL-Cincreasedin

both

grou

ps(17%

)Duringthe12

-mon

thfollo

w-up,

urinary

urea:creatinineratio

remained

stablein

both

grou

ps,

indicating

compliancewith

theprotein

prescription

(25)

Ganno

n20

03RCTcrossover/

5weeks

each

with2–

5-week

washo

utperiod

Type2

12adults

Higherproteinvs.

control(higher

CHO)

Higherprotein:

40%

CHO,

30%

fat,

30%

proteinvs.

higher

CHO:

55%

CHO,

30%

fat,

15%

protein

A1C

sign

ificantly

decreaseddu

ring

higher-protein

diet

(8.1–7.3%

)vs.

higher-CHO

diet

(8.0–7.7%

)(P

,0.05

)Mean24

-hintegrated

glucose

area

respon

se(fasting

glucose

concentrationas

baselin

e)sign

ificantly

decreasedafterthe

higher-protein

dietvs.the

higher-

CHO

diet(P

,0.02

)TGlower

onhigh

er-

proteindietvs.h

igher-

CHO

diet(161

vs.1

99mg/dL(P

50.03

)

Metabolic-unit–type

stud

y;allfoo

dsprovided

Weigh

tcontrolled

8 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(26)

Rod

rígu

ez-

Villar

2004

RCTcrossover/6

weeks

each,

withno

washo

ut

period

Typ

e2

22adults

HigherCHO

vs.

higher

MUFA

(oliveoil)diet

HigherCHO:

CHO

50→52

.3%

Fat30

→27

.9%

MUFA12

→13

.6%

Protein15

→18

.9%

vs.

HigherMUFA:

CHO

40→41

.4%

Fat40

→40

.2%

MUFA25

→24

.9%

Protein15

→17

.5%

Glycemicmeasures:NS

Higher-MUFA

dietdecreased

VLD

LTGs16

%(P

50.01

6)and

VLD

Lcholesterol

by35

%(P

50.02

3)compared

with

thehigher-CHO

diet.

Weightun

controlled

butstable(isocaloric

bydesign

)Fibersign

ificantly

higher

inCHO

diet

vs.h

igher-MUFA

(26g/day

vs.2

0.7,

P5

0.00

1)

(27)

Kod

ama

2009

Meta-analysis/

1966

–20

07Typ

e2

19stud

ies,30

6adults

HFLC

dietsvs.

LFHCdiets

Mediandiet

compo

sition

ofCHO/fatin

the

HFLC

andLF

HC

dietswere24

/58%

and40

/40%

,respectively

2-hPP

G(10trials),

fastinginsulin

(22

trials),and2-h

fastinginsulin

(9trials)increasedon

LFHCvs.H

FLC

(10.3%

,P,

0.00

1;8%

,P5

0.02

;12.8%

,P,

0.00

1,respectively)

HDL-Cdecreasedby

5.6%

(P,

0.00

1)on

LFHCvs.H

FLC

(20trials)

FastingTGincreased*

by13

.4%

(P,

0.00

1)on

LFHCvs.H

FLC

(22trials)

Weight-loss

trials

includedin

the

meta-analysis

Ofthe19

stud

ies

includedin

the

meta-analysis,o

nly

3werepu

blished

during

this

system

aticreview

timeperiod

andare

includedin

this

system

aticreview

(Miyashita[18],and

Rod

ríguez-Villar

[26],andLo

vejoy

[30])

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 9

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(28)

Kirk20

08Meta-analysis/

1980

–20

06Typ

e2

13stud

ies,26

3adults

Lower-CHO

diets

vs.h

igher-CHO

diets;lower-CHO

diets,single-arm

stud

ies

Lower-CHO

diets:

296

14%

kcal

from

CHO,range

4–45

%vs.h

igher-

CHO

comparison

diets:55

68%

kcalfrom

CHO,

range

40–70

%

Greater

meanreductio

nwithlower

CHO

vs.

high

erCHO

forFP

G;

regression

analysis:

10%

increase

inCHO

calorieintake

associated

with

3.26

1.2%

increase

inglucose,P

50.04

7A1C

was

reduced

more

onlower-CHO

diet

(9of

the11

trials)

Inregression

controlling

fordiet-phase

duration

,stron

grelation

ship

betw

een

low-CHO

phaseand

lower-TGlevels,1

0%increase

inCHO

calorieintake

associated

with7.66

0.6%

increase

inTG

change,P

50.00

1TGreduction

sfor

both

lower-and

high

er-CHO

diets

(11of

the11

trials)

Weightlossa

confou

ndingfactor

in6studies

Ofthe

13studies

inthe

meta-analysis,o

nly

4werepu

blished

during

this

system

aticreview

timeperiod

andmet

thissystem

atic

review

criteria

(Bod

en[10],Y

ancy

[14],G

erhard

[22],

andGanno

n[25])

10 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(29)

Rosenfalck

2006

RCTcrossover/

3mon

thseach

Typ

e1

10adults

Lower-fatdietvs.

convention

al“diabetes”diet

(European

Associationforthe

Stud

yofDiabetes)

Lower-fatdiet:

CHO

55→51

.4%

Fat25

→26

.2%

Protein20

→21

.1%

vs.

Con

vention

aldiet:

CHO

55→48

.7%

Fat30

→31

.2%

Protein15

→15

.1%

Insulin

sensitivity

byeuglycem

ic-

hyperinsulin

emic

clam

pim

proved

onthelower-fatdiet

comparedwiththe

convention

aldiet

(7.06vs.5

.52

g/kg/m

in,P

50.03

)CVDrisk

measures:

notdo

ne

77%

completionrate

Washo

utperiod

notprovided

Bodycompo

sition

remainedconstant

(isocaloricby

design

)Raw

food

materialsfor

lower-fatdietwere

delivered

topatients

whothen

prepared

theirow

nmeals

A1C

increasedfrom

baselin

efor

both

diets

(30)

Lovejoy

2002

RCTcrossover,

doubleblind,

4arms/4weeks

each

(minim

umof

2-week

washo

utperiod

)

Typ

e2

30adults

Higherfat/high

almon

dvs.low

erfat/high

almon

dvs.h

igherfat

controlvs.

lower-fatcontrol

Higherfat/high

almon

ds:

CHO48

%Fat3

7%(10%

from

almon

ds)

Protein15%

vs.

Lowerfat/high

almon

ds:

CHO60

%Fat2

5%(10%

from

almon

ds)

Protein15%

vs.

Higher-fatcontrol:

CHO48

%Fat3

7%(10%

from

oliveor

cano

laoil)

Protein15%

vs.

Lower-fatcontrol:

CHO60

%Fat2

5%(10%

from

oliveor

cano

laoil)

Protein15%

Glycemicmeasures:NS

HDL-Clower

inthe

almon

d-enriched

grou

ps(P

50.00

2)

Allfood

sprovided

during

thestudy

Weightcontrolled

Fiberalmostdo

ubled

during

thealmon

ddietsvs.the

control

Alm

onds

(57–11

3g/day

depend

ingon

total

energy

level)andthe

controloils

wereall

high

inMUFA

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 11

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

Carbo

hyd

rate

type:GI

(31)

Kabir20

02RCTcrossover/4

weeks

each

(15-day

washo

ut

period

)

Typ

e2

13men

Higher-GIvs.

lower-GI

breakfast

Higher-GIbreakfast:

who

le-grain

cereal,

who

le-w

heatbread

vs.low

er-GI

breakfast:who

le-

grainbreadand

mueslicon

taining

3gb-glucanfrom

oats

Glycemicmeasures:NS

TClower

afterthelower-

GIbreakfastperiod

than

thehigher-GI

breakfastperiod

(P,

0.03)

Weightno

tcontrolled

Fibercontent

comparablebetween

breakfasts

(19)

Wolever

2008

See“Carbo

hydrate

amou

nt:low

ercarboh

ydrate”

(32)

Rizkalla

2004

RCTcrossover/4

weeks

Typ

e2

12men

Lower-GIvs.

higher-G

Idiets

Usualdietwith

change

intype

ofCHO

only

LowerGI:pu

mpernickel,

pasta,lentils,

haricot,mun

gbeans,chickpeas;

achieved

GI5

39un

itsvs.

HigherGI:

whole-m

ealbread,

French

baguettes,

potatoes,w

hiterice;

achieved

GI5

71un

its

A1C

lower

onlower-GI

dietvs.h

igher-GIdiet

(7.17vs.7

.57%

)(P

,0.05

)Increm

entalAUCsforplasma

glucose(8-h

metabolic

profilesat4weeks)

loweron

lower-GIdiet

vs.higher-GIdiet

(P,

0.05)

TCandLD

L-Cdecreased

onlower-GIdietvs.

higher-GIdiet

(P,

0.05)

Weightno

tcontrolled,

didno

tchange

Fibersignificantlyhigher

onlower-GIdietvs.

higher-GIdiet

(P,

0.0001)

Insulin

sensitivity

(clamptechniqu

e)significantlyhigher

onlower-GIdietvs.

higher-GIdiet

(glucose

disposal:

7vs.4.8mgglucose/

kg/m

in)(P

,0.001)

Apo

lipop

rotein

Bdecreasedmoreon

lower-GIdietvs.

higher-GIdiet

(P,

0.01)

12 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(33)

Jimenez-

Cruz20

03RCTcrossover/6

weeks

(6-w

eek

washo

ut

period

)

Typ

e2

14adults

Lower

vs.

higher

GI

Typ

icallower-GI

food

s:oranges,

beans,yogurt,p

asta,

corn

tortillas;

achieved

GIand

GL,

44and86

units,respectively

vs.

Typ

icalhigher-G

Ifood

s:corn

flakes,

whitebread,

potatoes,ripe

bananas;achieved

GIandGL,

56and

139un

its,

respectively

A1C

lower

afterthe

lower-G

Iperiod

vs.

afterthehigh

er-GI

period

(8.1

vs.8

.6%)

(P5

0.02

)FB

Glower

during

the

lower-G

Iperiod

vs.

thehigh

er-GIperiod

(8.9

vs.1

0.0mmol/L)

(P5

0.04

)CVDrisk

measures:NS

39%

completionrate

Weightno

tcontrolled

(weigh

tdecreased

sign

ificantlymore

withlower

GIvs.

higher

GI[90.1vs.

92.0

kg,P

50.04

])Fiberhigh

eron

lowerGI(P5

0.00

3)

(34)

Heilbronn

2002

RCTparallel/8

weeks

Typ

e2

45adults

Lower-GIvs.

higher-G

Idiets

Both

dietswere

similarin

compo

sition

:Lo

wer

GI:

CHO

60→58

.9%

Fat15

→17

.9%

Protein20

→22

%GIgoal43

units

vs.

HigherGI:

CHO60→60.8%

Fat1

5→17.1%

Protein20→21

.7%

GIgoal75

units

Glycemicmeasures:NS

CVDrisk

measures:NS

Weight-loss

stud

yKey

food

swere

provided

AchievedGIun

its/

grou

pno

tprovided

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 13

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(35)

Jenkins

2008

RCTparallel/6

mon

ths

Typ

e2

155adults

High–

cerealfiber

dietvs.low

-GI

diet

Goaltokeep

fiber

constantwhile

reducingGI

10-20po

ints

End

-of-stud

ylower-G

Idiet:

69.6

unitsand

18.7

gfiber/1,00

0kcalvs.h

igh–

cerealfiberdiet:

83.5

unitsand

15.7

gfiber/1,00

0kcal

InITTanalysis:

A1C

decreased

by20.50

%absoluteun

itsin

thelower-G

Icompared

with20.18

%in

the

high

–cerealfiberdiet

(P,

0.00

1).T

he

difference

was

still

sign

ificantafter

controlling

forchanges

inbo

dyweight,fiber,

orcarboh

ydrate

FBGdecreasedin

lower

GI

vs.h

igher-cerealfiber

(P,

0.02

)HDL-Cincreasedin

the

lower-G

Idietby

1.7

mg/dL

comparedwith

adecrease

of20.2

mg/dL

inthe

high

–cerealfiber

diet(P

50.00

5)

Weightun

controlled

74%

completionrate

14 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(36)

Ma20

08RCTparallel/1

2mon

ths

Typ

e2

40adults

Lower-GIvs.

traditional

diabetes

diet

Lifestyleeducation:

Both

grou

ps:

goalof

55%

CHO,N

CEPfat

guidelines

Lower-G

Igrou

p:

reduceGIto

55un

itsfrom

baselin

e.AchievedGIat

12mon

ths;76

unitsvs.

traditional

diabetes

grou

p:

CHO

counting.

AchievedGIat

12mon

ths;

80un

its

Glycemicmeasure

(A1C

):NS

LDL-Chigher

inthe

lower-G

Igrou

pthan

inthetraditional

diabetes

grou

pat12

mon

ths,94

.50vs.

71.49mg/dL

(P5

0.04

8)

Weightno

tcontrolled;

notaweight-loss

stud

y;weightand

waistcircumference

didno

tdiffer

betweengrou

ps

Both

dietsreduced

A1C

andTCfrom

baselin

eto

endof

stud

y

(16)

Westm

an20

08See“Carbo

hydrate

amou

nt:low

ercarboh

ydrate”

(37)

Gilb

ertson

2001

Prospective,

stratified,

rando

mized,

parallelstudy

/12

mon

ths

Typ

e1

89youths

Lower-GIdietvs.

CHO-exchanges

diet

Lifestyleinterventio

n:MeasuredCHO-

exchange

dietsvs.

amoreflexible

food

pyramid–type

dietwithlower-GI

dietaryadvice

A1C

was

lower

for

lower

GI(7.776

0.79

%)compared

withCHO

exchanges

(8.766

1.07

%)(P

50.00

2)CVDrisk

measures:

notdo

ne

Weightno

tcontrolled

Despite

difference

indietaryinstruction,

therewas

nodifference

inmean

achieved

GIbetween

the2grou

ps(56.56

4.0and55

.36

4.8)

(P5

0.26

)Manypatients

appeared

toun

der-

repo

rtfood

intake

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 15

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(38)

Burani

2006

Retrospective

coho

rt(pre/

post)

Typ

es1and2

21adults

GI

Pre–

andpo

st–low-

GImedical

nutritiontherapy

Inindividualswith

stable/im

proved

A1C

afterinitiation

oflow-GImedical

nutritiontherapy,

A1C

improved

(pre:

7.5%

topo

st:6

%)

(P,

0.00

05)

BMIsign

ificantly

redu

ced

Medsreduced

inmost

subjects

GIsign

ificantly

redu

ced(m

ean

pre5

59vs.

post5

44)

(39)

Cheon

g20

09RCTparallel/1

6weeks

Typ

e2

38adults

Walkvs.eatmore

lower-GIfood

sandwalk

Lifestyleeducation:

Walkmorevs.eat

morelower-GI

food

sandwalk

more

Glycemicmeasure

(A1C

):NS

CVDrisk

measures:

notdo

ne

Subjectswerein

good

glycem

iccontrolb

eforethe

stud

y

(40)

Brand-

Miller

2003

Meta-analysis/

1981

–20

01Typ

e1and2

14stud

ies,35

6youthsand

adults

Lower

GIvs.h

igher

GI

Lower

GI:average

65vs.h

igherGI:

average83

A1C

reduced

0.34

%po

intsmoreand

fructosam

inereduced

0.18

mmol/L

more

withlower-GIdiet

vs.h

igher-GIdiet,

adjustingforbaselin

eandassuming

independence

CVDrisk

measures:no

tdo

ne

Allmeta-analysis

references,except

Gilb

ertson

(37),

werepu

blished

before

thestartdate

ofthissystem

atic

review

16 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(41)

And

erson

2004

Meta-analysis

Articlesincluded

werepu

blished

between19

78and20

00

Typ

e1and2

a.17

4b.

167

c.14

3

a.MCHFvs.M

CLF

b.HCHFvs.M

CLF

c.Lo

wGIvs.h

ighGI

Mod

erateCHO:

30–59

.9%

kcal

HigherCHO:

$60

%kcal

Higherfiber:

$20

g/1,00

0kcal

Lower

fiber:

,10

g/1,00

0kcal

PPGreduced

sign

ificantly

(anaverageof

21%)withMCHF

vs.M

CLF

TC,L

DL-C,and

TGredu

ced

sign

ificantly(7,8

,and8%

,respectively)

withMCHFvs.

MCLF

MCHFvs.M

CLF

associated

with

aninsign

ificant

decrease

inFB

G,

averagedaily

plasma

glucose

andHDL-C

HCHFvs.M

CLF

associated

with

redu

cedFB

G,P

PG,

averageplasma

glucose,A

1C,T

C,

LDL-C,H

DL-C,and

TG

LowGIvs.h

igh

GIassociated

with

redu

cedFB

Gand

A1C

Allmeta-analysis

references

were

publishedbefore

the

startdateof

this

system

aticreview

(42)

Tho

mas

2009

Meta-analysis/

inception

ofdatabases

(MEDLINE,

EMBA

SE,

CIN

AHL,

Cochrane)

toJune

2008

Typ

e1and2

11stud

ies,40

2youthsand

adults

Lower

GI/GL

Lower

GIin

individualswith

diabetes

not

optimally

controlled

A1C

decreasedby

0.5%

withlower-

GIdiet(P

50.02

forparalleltrials

andP5

0.03

for

crossovertrials)

CVDrisk

measures:

notdo

ne

CochraneLibrary

Ofthe11

stud

ies

includedinthemeta-

analysis,o

nly3were

publisheddu

ring/

after20

01andare

includedin

this

system

aticreview

(Rizkalla

[32],

Jimenez-Cruz[33],

andGilb

ertson

[37])

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 17

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(43)

Qi2

005

Cross-sectio

nal

Typ

e2

780men

Semiquantitative

FFQ

in19

86,

1990

,and19

94

GI,GLintake

ofdietaryfibers

andadipon

ectin

Glycemicand

CVDrisk

measures:

notdo

ne

HealthProfession

als’

Follo

w-upStudy

Trendtowardlower

adipon

ectinlevels

withincreasing

quintilesof

GI(13%

lower

inhigh

est

adipon

ectinqu

intile

comparedto

the

lowestP5

0.00

5)andalso

withGL

(18%

lower

inhighestqu

intile

than

thelowestP

fortrend5

0.00

4);

adipon

ectinlevels

19%

high

erin

highestqu

intile

than

lowestqu

intile

forcerealfiberintake

(Pfortrend

50.00

3)Carbo

hyd

rate

type:dietary

fiber

(45)

Ziai 2005

RCTparallel,

doubleblind,

2arms/8

weeks

Typ

e2

36adults

Psylliu

mfibervs.

inertcontrol

(cellulose)

2packets(5.1-g

each)of

psylliu

m/

dayin

water

vs.

microcrystalline

cellu

lose

A1C

decreasedfrom

10.5

to8.9%

(P,

0.00

1)in

psylliu

mgrou

pandincreased

from

9.1to

10.5%

(P,

0.05

)in

control

grou

pHDL-Cincreasedin

psylliu

mgrou

pand

decreasedin

control

grou

p(P

,0.05

betw

eengrou

ps)

Weightcontrolled

73%

completionrate

18 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(46)

Magno

ni

2008

RCTparallel,

doubleblind,

2arms/12

weeks

Typ

e2

36adults

Diabetes-specific

oralnu

trition

supp

lementvs.

control(isocaloric

standard

oral

supp

lement)

Inaddition

toregu

lar

diet,sub

jects

consumed

two

200mL/day

ofadiabetes-specific

supp

lement:35

%CHO,4

9%fat

(34%

kcalas

MUFA),2.5g

fiber/10

0mLvs.

astandard

supp

lement:

55%

CHO,3

4%fat(17%

kcalas

MUFA),0fiber

At12

weeks,1

50-

and21

0-min

PPG

increaseswere

sign

ificantlylower

ininterventio

ngrou

pvs.

control(P,

0.00

1)CVDrisk

measures:

notdo

ne

Weightun

controlled

(47)

Lu20

04RCTcrossover/

5-weeks

each

(nowasho

utperiod

)

Typ

e2

15adults

Arabino

xylanfiber

inbreadvs.b

read

witho

utthefiber

Fiber-enriched

bread/m

uffin

prod

ucts(50%

who

le-w

heatflou

r,36

%whiteflou

r,14

%fiber-enriched

flou

r)vs.con

trol

prod

ucts(50%

who

le-w

heatflou

rand50

%white).

Subjectsreplaced

moststarchyfood

swith4–

5slices

ofbreadand1–

2muffins,d

epending

onenergy

needs

Add

ed-fiberdiet2-h

PPG(by75

-gOGTT)

was

lower

than

controld

iet(P

50.00

1),aswas

serum

insulin

(P5

0.01

5);serum

fructosam

inewas

lower

afterfiberdiet

vs.con

trol

(P5

0.02

)CVDrisk

measures:NS

Weightun

controlled

butno

sign

ificant

difference

between

grou

ps

Com

pletionrateno

tprovided

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 19

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(48)

Vuk

san

2007

RCTcrossover,

singleblind/12

weeks

each

(4–6-week

washo

ut

period

)

Typ

e2

20adults

Salba(novelwho

legrain)vs.w

heat

bran

376

4g/day

ofSalbaor

wheat

bran

Glycemicmeasures:NS

CVDrisk

measures:NS

Weightcontrolled

74%

completionrate

A1C

sign

ificantly

redu

ced(6.9–6.7%

from

baselin

eto

12weeks

inSalba

grou

p(P

,0.05

)High-sensitivity

CRP

lower

inSalbagrou

p(P

50.04

)vs.w

heat

bran

(49)

Jenkins

2002

RCTcrossover/

3mon

thseach

(2-m

onth

washo

ut

period

)

Typ

e2

23adults

Wheatbran

fiber

vs.con

trol

(no

wheatbran)

Wheatbran-enriched

breadandcereal

(24%

ofdaily

energy

needs,

averageof

19g

fiber/day)

vs.

controlw

hitebread

andcereal(24%

daily

energy

needs,

4gfiber/day)

provided

assole

source

ofbreadand

cerealfor3-mon

thperiod

each

Glycemicmeasures:NS

CVDrisk

measures:NS

Weightun

controlled,

butno

sign

ificant

difference

between

grou

ps

34%

completionrate

20 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(50)

Cho

2005

RCTparallel,

2arms/2

mon

ths

Typ

e2

30adults

Solublefiber(Cassia

tora,a

herbal

legume)

vs.

maltodextrin

Powderpacket

containing

2g

solublefiberfrom

Cassiatora

plus

200mg

a-tocop

herol,

500mgvitamin

C,

300mg

maltodextrin

vs.

3-gpacketof

maltodextrin

only

(2packets/dayfor

2mon

ths)

Glycemicmeasures:NS

CVDrisk

measures:NS

Weightun

controlled,

butanthropo

metric

indicesdidno

tchange

71%

completionrate

(51)

Ble-Castillo

2010

RCTcrossover/4

weeks

(blin

ded

withinsubject)

(nowasho

utperiod

)

Typ

e2

28ob

eseadults

Nativebanana

starch

vs.soy

milk

24gnativ

ebanana

starch

powderper

dayvs.con

trol

of24

gsoymilk

powder,each

dissolvedin

water

Glycemicmeasures:NS

Soymilk

sign

ificantly

reduced

serum

TG(baselineto

end,

P,

0.05

)and

comparedwiththe

nativebanana

starch

(P5

0.01

2)

Weightun

controlled

(moreweigh

twas

lostwithnative

banana

starch

than

withsoymilk

)Other

treatm

entsand

medicines

werecon

trolled

Fastinginsulin

concentrationand

insulin

sensitivity

(HOMA)im

proved,

baselin

eto

endfor

native

bananastarch

grou

p(P

50.01

and

P,

0.05

,respectively)

(35)

Jenkins

2008

See“Carbo

hydrate

type:G

I”

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 21

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(52)

DeNatale

2009

RCTcrossover/4

weeks

each

(nowasho

utperiod

)

Typ

e2

18adults

HigherCHO

(higher

fiber,lower

fat

andGI)vs.h

igher

MUFA

(low

erCHO

andfiber,

higher

fatandGI)

Isocaloricdiets:

HigherCHO

vs.

high

erMUFA

(achieved)

CHO:5

1vs.4

4%Fiber:27

vs.

8g/1,00

0kcal

Fat:30

vs.3

7%MUFA:1

7vs.2

3%GI:60

vs.8

7

After

theendof

stud

y,high

er-CHO,h

igher-

fibertestmealvs.the

MUFAtestmeal:

Plasmaglucose

IAUC

decreasedun

tilthe

thirdho

ur(P

,0.05

)Sign

ificantredu

ction

ininsulin

IAUC(by

14and21

%)at3and

6h,

respectively

(P,

0.05

)Decreaseof

nearly50

%in

postprandialglycemic

variability

(P,

0.02

)FastingTC,L

DL-C,

andHDL-C

sign

ificantlyreduced,

high

erCHO

vs.

MUFA(P

,0.05

for

each)

22 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(53)

Qi2

006

Cross-sectio

nal

Typ

e2

902wom

enSemiquantitative

FFQ,p

astyear

Intake

ofcerealand

fruitfiber,dietary

GLandGI,and

markerof

insulin

sensitivity

(adipon

ectin)

GlycemicandCVD

risk

measures:

notdo

ne

Nurses’HealthStud

yWeightcontrolled

Cerealfi

berand

fruitfiberpo

sitively

associated

with

increasing

adipon

ectin(P

50.00

2andP5

0.03

6,respectively)

afteradjustingfor

confou

nding

variables

GLandGInegatively

associated

with

adipon

ectinon

lyafteradjustment

forBM

I(P

50.01

andP5

0.03

,respectively)

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 23

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(54)

Qi2

006

Cross-sectio

nal

Typ

e2

902wom

enFF

QIntake

ofwho

legrain,

bran,cerealfi

ber,

dietaryGLandGI,

andmarkersof

system

atic

inflam

mation

(CRP,

TNF)

GlycemicandCVD

risk

measures:

notdo

ne

Nurses’HealthStud

yWeightcontrolled

Decreasinglevelsof

CRPwithhigh

erintakesof

who

legrainsandbran

(Pfortrend5

0.03

,Pfortrend5

0.00

7,respectively)

Decreasinglevelsof

TNF-R2withhigh

erintakesof

who

legrains(P

for

trend5

0.01

7)Highdietaryglycem

icindexwas

associated

withsign

ificantly

increasing

trendof

CRPandTNF-R2

levels(P

fortrend5

0.04

and0.00

08,

respectively)

24 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(55)

Steembu

rgo

2009

Cross-sectio

nal

Typ

e2,

withor

witho

utthe

metabolic

syndrom

e

214adults

3-dayweighed

diet

Dietary

fiberintake

Glycemicmeasures:NS

Protective

effect

withsolublefiber

from

who

le-grain

food

sforTG,

metabolicsyndrom

evs.n

ometabolic

syndrom

e(P

50.03

)

Subjectswithbo

thdiabetes

andthe

metabolicsyndrom

ehadlower

intakesof

both

totald

ietary

fiberandsoluble

fiber,mainlyfrom

fruitsandwho

legrains(16.7g/day

vs.1

9.5,

P,

0.01

0and5.3g/day

vs.6

,P,

0.01

1,respectively)than

subjectswith

diabetes

butwith

out

themetabolic

syndrom

e(41)

And

erson

2004

See“Carbo

hydrate

type:G

I”(43)

Qi2

005

See“Carbo

hydrate

type:G

I”(56)

He20

10Prospective

coho

rt/

1980

–20

02

Typ

e2

7,82

2wom

enSemiquantitative

FFQ

(7years)

Who

legrain,cereal

fiber,bran,and

germ

Glycemicmeasures:no

tdo

ne

Inafully

adjusted

mod

el(lifestyleanddietary

variablesconsidered),

onlytheinverse

associationbetw

een

bran

intake

andCVD-

specificmortalitywas

sign

ificant

Nurses’HealthStud

y

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 25

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

Fat

amou

nt

(21)

Barnard

2009

See“Carbo

hydrate

amou

nt:

mod

erateto

high

carboh

ydrate”

(22)

Gerhard

2004

See“Carbo

hydrate

amou

nt:

mod

erateto

high

carboh

ydrate”

(29)

Rosenfalck

2006

See“Carbo

hydrate

amou

nt:

mod

erateto

high

carboh

ydrate”

(23)

Wycherley

2010

See“Carbo

hydrate

amou

nt:

mod

erateto

high

carboh

ydrate”

(57)

Mostad

2004

Clin

icaltrial/3

days

Typ

e2

19adultswith

hypertriglyceridemiaUsualdietvs.

low-fatdiet

Usualdiet(fat39

%)

vs.low

-fatdiet

(sub

jectsadvised

toincrease

fiber-

rich

andlow-fat

food

sandto

decrease

intake

ofvisiblefatin

anisoenergetic

manner):fat22

%

Glycemicmeasures:NS

TCandHDL-C

decreased6.3–

6.2

mmol/L

(P,

0.00

5)and1.13

–1.10

mmol/L

(P,

0.04

8)

Weightno

tcontrolled,

andnegative

energy

balance

resulted

with

redu

ctionof

fatin

diet

26 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(58)

Cop

pell

2010

RCTparallel,

2arms/6

mon

ths

Typ

e2

94adultswith

persistently

unsatisfactory

glycem

iccontrol

Intensive

dietary

advice

grou

pvs.con

trol

grou

p

Intensive

dietary

advice

grou

p,

recommendatio

nsbasedon

EASD

:CHO

45–60

→48

%Fat,30

→28

.7%

SFA,8–

10→9.7%

PUFA

10→5.6%

Proteinno

recommendation→

22.1%

Fiber40

→26

.3g/day

vs.

Con

trol:n

oadvice

CHO

→48

.5%

Fat→29

.9%

SFA→11

.3%

PUFA

→4.7%

Protein→20

.4%

Fiber→23

.5g/day

A1C

decreasedmore

inintervention

grou

p(8.9

to8.4%

)vs.

controlgroup

(stable

at8.6%

)after

adjustmentfor

baselin

evalues,age,

andsex(P

50.00

7)CVDrisk

measures:NS

Weightlosswas

apartof

intervention

Interventio

ngrou

predu

ceddiabetes

medssign

ificantly

(59)

Yip20

01RCTparallel,

3arms/12

weeks

Typ

e2

57adults

Mealreplacements

vs.exchange

dietplan

Slim

-Fast(con

taining

lactose,fructose,

sucrose)

Sugar-free

Slim

-Fast

(fructoseandsucrose

replacedwith

oligosaccharides)

Exchange

dietplan

(55–

65%

CHO,

,30

%fat,10

–20

%protein)

FBGdecreasedin

the

Slim

-Fastgrou

ps

over

timecompared

withtheexchange

dietplan

grou

p(P

50.01

2)CVDrisk

measures:NS

Weight-loss

stud

y76

%completion

rate

Nosign

ificant

differencesbetw

een

Slim

-Fastandsugar-

free

Slim

-Fast,so

they

werepo

oled

andcomparedwith

theexchange

diet

plan

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 27

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(60)

Li20

05RCTparallel,

2arms/12

mon

ths

Typ

e2

77adults

Soy-basedmeal

replacementvs.

individu

aldiet

plan

1–3meals/day

replacedwith

Slim

-Fastvs.

individualized

diet(55–

65%

CHO,,

30%

fat,

10–20

%protein).

500-calorie/day

energy

deficit.

A1C

decreased,

Slim

-Fastvs.ind

ividualized

diet,at3mon

thson

ly(P

,0.05

)FB

Gdecreased,

Slim

-Fast

vs.individu

alized

diet,

at3and6mon

ths

only(P

,0.05

)CVDrisk

measures:NS

74%

completionrate

Weight-loss

stud

y

(61)

Snell-

Bergeon

2009

Cross-sectio

nal/

case-con

trol

Typ

e1

571and69

6control

Examined

diet

variablesand

correlationwith

CHDrisk

factors

Self-administered

FFQ

A1C

correlated

with

%fat(0.07),%

saturatedfat(0.06),

%MUFA(0.06),%

CHO

(20.07

),P,

0.05

(all

correlations)

TCcorrelated

with%

fat(0.14),%

saturated

fat(0.12),%

transfat

(0.11),%

MUFA

(0.14),%

CHO

(20.14

),P,

0.00

1(allcorrelations)

LDL-Ccorrelated

with

%fat(0.15),%

saturated

fat(0.14),%

transfat

(0.12),%

MUFA

(0.16),%

PUFA

(0.06),

%CHO

(20.13

),P,

0.00

1(allcorrelations)

HDL-Cnegatively

correlated

andTG

positivelycorrelated

withGI(P

,0.05

andP,

0.00

1,respectively)

Weightcontrolled

Partof

thebaselin

eexam

inationof

the

CACTIstud

y

28 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

Saturatedfat

(62)

Rivellese

2008

RCTcrossover/3

weeks

each

(washou

tperiod

notspecified)

Typ

e2

11adults

SFAvs.M

UFA

Dietsisoenergetic

bydesign

.SFA-

rich

dietgoal:

17%

SFA,1

5%MUFAvs.M

UFA-

rich

dietgoal:8

%SF

A,2

3%MUFA

Both

dietswere

design

edto

contain

46%

CHO,3

7%fat,

17%

protein,

21g

fiber.Cho

lesterol

was

428mgon

the

SFAdietand13

0mg

ontheMUFAdiet.

Glycemicmeasures:NS

Decreasein

small

VLD

Ltriglyceride

increm

entalareaafter

theMUFAdiet

(213

.66

4.7

mg/dL

at6h

vs.2

2.26

3.7mg/dL

at6h,

P,

0.00

5)

Alllunches

and

dinn

ersprovided

tosubjects

Weightun

controlled,

butno

sign

ificant

difference

inbo

dy

weight

Omega-3fattyacids

(63)

Mostad

2006

RCTparallel,

singleblind/9

weeks

Typ

e2

26adults

Fish

oilvs.

corn

oil

Fish

oilgroup

:20ml

fish

oilenriched

withom

ega-3fatty

acidsvs.cornoil

(equ

alam

ount)

FBGincreasedin

the

fish

oilgroup

(;1mmol/L

high

erthan

thecorn

oil

grou

p,P5

0.03

5)CVDrisk

measures:NS

Weightno

tsign

ificantly

changeddu

ring

intervention

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 29

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(64)

Woo

dman

2002

RCTparallel,

doubleblind/6

weeks

Typ

e2

51adults

EPA

orDHA

vs.o

liveoil

4gof

each

oil/d

ayFB

Gin

theEPA

and

DHAgrou

psincreased

1.40

and0.98

mmol/L

(P5

0.00

2foreach),

respectively,vs.olive

oil

TGin

EPA

andDHA

grou

psdecreased

19and15

%(P

50.02

2each),

respectively,vs.olive

oil

HDL-2in

theEPA

andDHAgrou

psincreased16

%(P

50.02

6)and12

%(P

50.05

),respectively,vs.

oliveoil

HDL-3decreased11

%(P

50.02

6)with

EPA

vs.o

liveoil

Weight

controlled

(65)

Pedersen

2003

RCTparallel,

doubleblind/8

weeks

Typ

e2

44adults

EPA

1DHAvs.

corn

oil

EPA

1DHA:2

.6-g

daily

in4capsules

(76%

omega-3

and3.4%

omega-6

PUFA

)vs.4

capsulesof

corn

oil(0%

omega-3

and55

.9%

omega-6PU

FA)

Glycemicmeasures:NS

HDL-Chigh

erin

fish

oilgroup

(10.07

mmol/L)vs.2

0.01

incorn

oil,P5

0.04

5TGlower

infish

oil

grou

p(2

0.53

mmol/L)vs.2

0.08

incorn

oil,P5

0.02

5LD

L-Cun

saturation

index

increasedin

fish

oilgroup

vs.cornoil

grou

p

Weight

uncontrolled

30 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(66)

Pooya20

10RCTparallel,

doubleblind/2

mon

ths

Typ

e2

81adults

Omega-3fatty

acidsvs.con

trol

ofsunfl

ower

oil

Omega-3fattyacid

capsules/day

(1,548

mgEPA

,82

8mgDHA,

338mgother

omega-3fatty

acid)vs.con

trol

capsules/day

(2,100

mg

sunfl

ower

oil,

12%

SFA,7

1%lin

oleicacid,

15%

MUFA)

A1C

decreasedin

omega-3fattyacid

grou

p(2

0.75

%)vs.

0.26

incontrol,P,

0.00

1CVDrisk

measures:NS

Weightun

controlled

(67)

Hartweg

2009

Meta-analysis/

1966

–20

08Typ

e2

24trials

1,53

3adults

Fish

oil,om

ega-3

fattyacid,P

UFA

,EPA

,DHAvs.

placebo/control

Average

daily

intake

offish

oild

uring

totalp

eriodwas

;2.4gom

ega-3

PUFA

sover

24weeks

forthe7

stud

iesadded

2007

–20

08

Glycemicmeasures:NS

TGdecreasedwith

omega-3PU

FA

supplem

entation

by7%

(mean20.17

mmol/L;2

4trials;

1,53

0participants)

vs.con

trol

(P,

0.00

01)

LDL-Cincreasedwith

omega-3PU

FAby

3%(m

ean0.08

mmol/L;2

1trials;

1,10

4participants)

vs.con

trol

(P5

0.00

6)

Ofthe23

stud

ies

includedin

the

meta-analysis,6

meeting

this

system

aticreview

criteriawere

publisheddu

ring

thesystem

atic

review

timeperiod

(Mostad[63],

Woo

dman

[64],

Pedersen

[65],

Petersen

[68],

Kabir[69],and

Shidfar[70])

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 31

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(68)

Petersen

2002

RCTparallel,

doubleblind/8

weeks

Typ

e2

42adults

Fish

oilvs.

corn

oil

4gdaily

ofeither

fish

oilo

rcorn

oil

Glycemicmeasures:NS

TGdecreased0.54

mmol/L

infish

oilgroup

vs.0

.04

mmol/L

incorn

oil

grou

p,P5

0.02

5HDL-2a

redu

ction

was

smallerin

the

fish

oilgroup

than

inthecorn

oilgroup

(P5

0.00

7)

Weightcontrolled

(69)

Kabir20

07RCTparallel,

doubleblind/2

mon

ths

Typ

e2

27po

stmenop

ausal

wom

enFish

oilvs.

paraffinoil

Fish

oilcapsules:

3g/day

(1.8

gom

ega-3PU

FAs:

1.08

gEPA

10.72

gDHA)vs.

paraffinoil

capsules:3g/day

Glycemicmeasures:NS

TGandratioof

TG-to-HDL-C

(atherogenicindex)

werelower

inthefish

oilgroup

than

inthe

paraffinoilgroup

(P,

0.03

foreach)

Bodyweigh

tun

changed

(70)

Shidfar

2008

RCTparallel,

doubleblind/10

weeks

Typ

e2

50adults

omega-3fatty

acidsvs.

control

omega-3fattyacid

capsules:52

0mg

EPA

148

0mg

DHAdaily

vs.

controlcapsules:

300mgSF

A,

100mgMUFA,

600mglin

oleic

acid

Glycemicmeasures:NS

TGdecreasedby

31%

andTG-to-

HDL-Cratio

decreasedfor

omega-3grou

pvs.

control(P5

0.01

andP5

0.04

,respectively)

Weightcontrolled

32 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(71)

Kesavulu

2002

Clin

icaltrial,

singlearm/2

mon

ths

Typ

e2

34adults

EPA

1DHA

1,08

0mgEPA

172

0mgDHA

daily

Glycemicmeasures:NS

HDL-Cincreased,

0.93

mmol/L

before

vs.

1.04

mmol/L

after

therapy(P

,0.01

)TGdecreased,

2.07

mmol/L,b

eforevs.

1.54

mmol/L

after

therapy(P

,0.05

)VLD

L-Cdecreased

aftertreatm

ent

(P,

0.05

)(73)

Belalcazar

2010

Prospective

coho

rt/

baselin

eand

1year

Typ

e2

2,39

7FF

QMarineom

ega-3

fattyacid

intake

basedon

8lin

eitem

sin

theFF

Qinqu

iringabou

tseafoo

dconsumption

A1C

:noassociation

atbaselin

eBaselin

emarine

omega-3fattyacid

intake

was

1626

138mg/dandwas

inverselyassociated

withTGs(P

,0.00

1)

Weightlosswas

agoal

ofRCTfrom

which

thedatacame

(Loo

kAHEAD)

1-year

marineom

ega-3

fattyacid

andfried

fish

intake

decreased

withtheintensive

lifestyleintervention

(P,

0.00

1)Protein

(25)

Ganno

n20

03See“Carbo

hydrate

amou

nt:

mod

erateto

high

carboh

ydrate”

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 33

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(74)

Parker

2002

RCTparallel/12

weeks

(8-w

eeks’

weightloss

intervention

14-weeks’weight

maintenance)

Typ

e2

54adults

Higherproteinvs.

lower

protein

Higher-protein

diet:

CHO

40→42

.1/

42.6%†

Fat30

→27

.8/27.6%

Protein30

→28

.1/

27.7%

vs.

Lower-protein

diet:

CHO60→54.8/55.0%

Fat2

5→26.3/26.7%

Protein15→16

.4/

16/0%

Fattyacid

%same

inboth

diets

Glycemicmeasures:NS

TCandLD

L-Cwere

lower

after12

weeks

inthehigher-

proteingrou

pvs.

lower-protein

grou

p(P

50.00

9for

diet-by-time

interaction)

Weight-loss

stud

ySomefood

supplied

Fiberintake

sign

ificantlyhigh

erin

thelower-protein

grou

pdu

ringweight

losspartof

thestud

ySeeBrinkw

orth

2004

fora1-year

follo

w-

upof

thestud

y

(24)

Brinkw

orth

2004

See“Carbo

hydrate

amou

nt:

mod

erateto

high

carboh

ydrate”

(23)

Wycherley

2010

See“Carbo

hydrate

amou

nt:

mod

erateto

high

carboh

ydrate”

34 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

Protein/diabetickidney

disease

(75)

Pijls

2002

RCTparallel,

physician

blinded/24

mon

ths

Typ

e2with

micro-or

macroalbu

minuria,

orwith

diabetes

.5years

131adultswith

afollo

w-upof

.12

mon

ths

Lower-protein

dietvs.u

sual-

proteindiet

Lower-protein

grou

p:p

rotein

0.8g/kg/day→

1.11

g/kg/day

(at24

mon

ths)

vs.

Usual-protein

grou

p:p

rotein

1.07

g/kg/day

achieved

at24

mon

ths

Glycemicmeasures:

notdo

ne

CVDrisk

measures:

notdo

ne

Weightno

tcontrolled

59%

retention

rateat

24mon

ths

Nosign

ificant

differencesbetw

een

grou

psforGFR

oralbu

minuria

(76)

Melon

i20

04RCT parallel/

1year

Typ

es1(24)

and

2(56)

with

macroalbu

minuria

80adults

Lower-protein

dietvs.free-

proteindiet

Lower-protein

diet:p

rotein

0.8g/kg/day

→0.86

g/kg/day

vs.

Free-protein

diet:p

rotein

1.24

g/kg/day

achieved

Glycemicmeasures:NS

CVDrisk

measures:NS

Meanbo

dyweigh

tdecreased

sign

ificantlyin

lower-protein

grou

pvs.free-protein

grou

pNosign

ificant

difference

inrenal

functio

n(GFR,A

ER)

betweengrou

ps

Nosign

sof

malnu

trition

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 35

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(77)

Hansen

2002

RCT parallel/

4years

Typ

e1with

macro-

albu

minuria

72(at1year)

adults

Lower-protein

dietvs.u

sual-

proteindiet

Lower-protein

grou

p:p

rotein

0.6g/kg/day→

0.89

g/kg/day

(range

0.83

–0.95

g)vs.

Usual-protein

grou

p:p

rotein

achieved

1.02

g/kg/day

(range

0.95

–1.1g)

Glycemicmeasures:NS

CVDrisk

measures:NS

Weightno

tcontrolled,

butno

sign

ificant

difference

betweengrou

ps

Nosign

ificant

difference

between

grou

psfor

albu

minuriaor

GFR

(78)

Dussol

2005

RCT parallel/

2years

Typ

es1and2

41adultswith

micro-

albu

minuria,

6with

macroalbu

minuria

Lower-protein

dietvs.u

sual-

proteindiet

Lower-protein

grou

p(actual):16

63%

kcalas

protein

vs.u

sual-protein

grou

p(actual):

196

4%kcalas

protein.

How

ever,

calculated(M

aron

iform

ula)as

gprotein/kg/day,the

lower-protein

grou

p(0.8

g/kg/day

prescribed)at

baselin

e,12

mon

ths,

and24

mon

thswas

1.08

,1.02,

1.10

vs.

theusual-protein

grou

p(1.13,

1.18

,1.03

)

Glycemicmeasures:NS

CVDrisk

measures:NS

75%

completionrate

Duringstud

y,bo

dyweightandserum

albu

min

were

similarbetw

een

grou

ps

Nosign

ificant

difference

between

grou

psforGFR

,AER,o

rurinary

urea

excretion

Allsubjectsun

derstrict

bloo

dpressure

control

36 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(79)

Pan20

08Meta-analysis/

1966

–20

07/

duration

.6

mon

ths

Typ

es1and

2with

macro-

albu

minuria

8studies/

519adults

Lower-protein

dietsvs.

control(usual

protein)

Lower-protein

grou

ps:average

proteinintake

0.91

g/kg/day

vs.

usual-protein

grou

ps:average

proteinintake

1.27

g/kg/day,

P5

0.04

for

difference

A1C

decreased

sign

ificantly,

lower

protein

vs.con

trol

(weigh

tedmean

difference,

0.31

%)

CVDrisk

measures:

notdo

ne

Ofthe8studies

includedin

the

meta-analysis,4

werepu

blished

during/after

2001

andareincludedin

thissystem

atic

review

(Pijls[75],

Melon

i[76

],Hansen

[77],andDussol

[78])

Overall,

achange

inweightedmean

difference

for

GFR

orcreatinine

clearanceratewas

notsign

ificantly

associated

with

alower-protein

diet

Altho

ugh

thebenefit

oflower-protein

diet

therapyon

proteinu

riawas

sign

ificant

(P,

0.00

3),great

heterogeneity

was

observed

Inasubgroup

analysis,

thechange

inthe

weightedmean

difference

forserum

albu

min

was

sign

ificant

(reductionof

1.18

g/L;

95%

CI:21.33

to1.03

g/L)

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 37

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(80)

Rob

ertson

2007

Meta-analysis/

beginningof

databases

searched

throug

hJuly

2006

/duration

.4mon

ths

Typ

es1and

2with

macroalbu

minuria

12stud

ies/

585adults

Mod

ified/

restricted-

proteindiets

vs.con

trol

Lower-protein

diet:actual

intake

0.7–

1.1g/kg/day

vs.u

sual-

proteindiet:

actualintake

1–2g/kg/day

Glycemicmeasures:NA

CVDrisk

measures:NA

CochraneLibrary

Ofthe12

stud

ies

includedin

the

meta-analysis,3

werepu

blished

during/after

2001

andmetthis

system

aticreview

criteria(Pijls[75],

Melon

i[76

],and

Hansen[77]).

Nosign

ificant

difference

between

lower-protein

and

usual-protein

dietsforGFR

38 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(81)

Gross 2002

RCTcrossover,

3arms/4

weeks

each

(4-w

eek

washo

ut

period

s)

Typ

e2

28adults(15with

norm

oalbuminuria

and13

with

microalbu

minuria

Usualdiet

(meat)vs.

chickendiet

vs.low

er-

protein/

vegetarian

diet

Usualdiet(m

eat):

protein1.2–

1.5g/kg/day

→1.43

g/kg/day

vs.

Chicken

diet

(usual-diet

meatreplaced

bychickenlegs):

protein1.2–

1.5g/kg/day

→1.35

g/kg/day

vs.

Lower-protein,

vegetarian

diet

(protein

from

milk

and

vegetable

sourceson

ly):

protein0.5–

0.8g/kg/day

→0.66

g/kg/day

Glycemicmeasures:NS

TCsign

ificantly

lower

after

chickendiet

andlow-protein/

vegetarian

diet

ascompared

withusualdiet

(P,

0.05

)in

microalbu

minuric

subjectson

ly

Weightno

tcontrolled;

energy

intake

andweight

sign

ificantlylower

during

thelow-

protein/vegetarian

dietthan

other

2diets

GFR

sign

ificantlylower

afterlow-protein/

vegetarian

diet

comparedwith

other

2diets

(P,

0.05

),microalbu

minuric

subjectson

lyUAER(in

microalbu

minuric

subjectson

ly)

sign

ificantlylower

afterchickendiet

comparedwith

other

2diets,

P,

0.05

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 39

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(82)

Teixeira

2004

RCT crossover/8

weeks

each

(4-w

eek

washo

ut

period

)

Typ

e2with

macroalbu

minuria

14men

Isolated

soy

proteinvs.

casein

0.5g/kg/day

isolated

soy

proteinpo

wder

vs.0

.5g

protein/kg/day

casein

powder

Glycemicmeasures:NS

HDL-Csign

ificantly

increased0.04

mmol/L

after

isolated

soy

protein(P

50.00

41);

decreased

0.03

mmol/L

aftercasein

(P5

0.08

47);effectof

dietdepend

edon

baselin

eHDL-C

(P5

0.03

91for

interaction)

with

larger

differences

betw

eentreatm

ents

inmen

withhigher

baselin

eHDL-C

41%

completion

rate

Nodifferencesin

BMI

bystudy

period

(multipleregression

)Su

bjectsaddedprotein

powdersdu

ring

the

intervention

period

sinsteadof

substituting

foro

ther

proteins

asinstructed

UACsign

ificantly

decreasedafter

isolated

soyprotein

dietvs.casein(P

,0.00

1)with

larger

differencesbetw

een

dietsin

men

with

higher

baselin

eUAC

40 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(83)

Azadb

akht

2008

RCTparallel/

4years

Typ

e2with

macroalbu

minuria

41adults

Soyprotein

vs.con

trol

Soyprotein

grou

p:0

.8g

protein/kg/

day(35%

anim

alprotein,

35%

textured

soy

protein,

30%

vegetable

protein)

prescribed.

Proteinachieved

was

55–57

g/day

(617

–23

)vs.

controlgroup

:0.8gprotein/

kg/day

(70%

anim

alprotein,

30%

vegetable

protein)

prescribed.

Protein

achieved

was

55–58

g/day

(617

–23

)

FBGmean

change

insoy

grou

p218

mg/dL

vs.1

11mg/dL

incontrol(P5

0.03

)TCmeanchange

insoygrou

p223

mg/dL

vs.

110

mg/dL

incontrol(P5

0.01

)LD

L-Cmeanchange

insoygrou

p220

mg/dL

vs.1

6mg/dL

incontrol(P5

0.01

)TGmeanchange

insoygrou

p224

mg/dL

vs.2

5mg/dL

incontrol(P5

0.01

)

Weightcontrolled

inanalyses

CRPmeanchange

insoygrou

p21.31

mg/dLvs.1

0.33

mg/dLin

control

(P5

0.02

)Sign

ificant

improvem

entin

proteinu

ria(2

0.15

vs.0

.02g/day,P

50.00

1)soyvs.

control;ho

wever,

thesign

ificance

disappeared

after

controlling

for

changesin

thebloo

dlip

idprofi

le

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 41

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(84)

deMello

2006

RCTcrossover,

3arms/4weeks

each

(4-w

eek

washo

ut

period

s)

Typ

e2

17adultswith

macroalbu

minuria

SeeGross

2002

SeeGross,2

002.

Usualdiet:p

rotein

17–25

→21

.9%

vs.

chickendiet:

protein17

–

25→21

.2%

vs.

lower-protein/

vegetarian

diet:

0.5–

0.8g/kg/

day→

11.6%

kcal

Glycemicmeasures:NS

TGsign

ificantly

lower

after

chickendietvs.

usualdietor

lower-protein/

vegetarian

diet

(P5

0.01

2)

43%

completion

rate(m

ost

excludedfor

revertingto

microalbu

minuria)

Weightno

tcontrolled;

BMIandenergy

intake

sign

ificantly

lower

afterlower-

protein/vegetarian

dietthan

other

2diets

Nosign

ificant

difference

amon

ggrou

psforGFR

UAERsign

ificantly

lower

afterchicken

andlower-protein/

vegetarian

diets

comparedwith

usualdiet,P,

0.00

1Nuts

(85)

Ma 20

10RCTcrossover,

singleblind/

8weeks

each

(8-w

eek

washo

ut

period

)

Typ

e2

21adults

Walnu

ts56

gshelled,

unroasted

Eng

lishwalnu

ts/

dayisocalorically

substitutedfor

food

sin

anad

libdietvs.adlib

diet

Glycemicmeasures:NS

CVDrisk

measures:NS

Walnu

tsprovided

tosubjects

End

othelialfun

ction

(flow

-mediated

dilation

)im

proved

sign

ificantlyafter

consum

ptio

nof

thewalnu

t-enriched

dietcomparedwith

theno

walnu

tdiet

(2.2

61.7%

vs.

1.26

1.6%

,P5

0.04

)

42 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(86)

Tapsell

2004

RCTparallel,

3arms/6

mon

ths

Typ

e2

55adults

Lower-fat

dietsvs.

lower-fat

diet1

walnu

ts

Lower-fatdiet:

,30

%fat,with

portion

controlledCHO

coun

ting

meal

plansandgeneral

dietaryadvice

for

reducingtotal

andSF

Avs.

mod

ified

lower-

fatdiet:sam

eas

lower-fatdietbu

twithmore

structured

advice,

mealp

lansbased

onenergy

requ

irem

ents,

andexchange

lists

forMUFA

and

PUFA

vs.m

odified

lower-fatdiet1

30g/daywalnu

ts

Glycemicmeasures:NS

The

walnu

tgrou

pachieved

asign

ificantly

greaterincrease

inHDL-C-to-total

cholesterolratio

(P5

0.04

9)and

HDL-C(P

50.04

6)than

the

2other

treatm

ent

grou

ps

Walnu

ts(highin

PUFA

)provided

tosubjects

Gillen

2005

contains

dietaryvariables

anddietarygoals

outcom

einform

ation

(87)

Gillen 2005

SeeTapsell

2004

Targetrangesof

,10

%SF

A,

.7%

PUFA,

2.22

gALA

,0.65

gDHA,and

omega-6:om

ega-3

ratio,10

Prim

aryou

tcom

esforthisstud

yweredietary

variablesand

goals.See

Tapsell20

04forstud

ydetails

and

clinical

outcom

es

100%

ofindividu

als

inthewalnu

tgrou

preached

desiredintakes

forSF

As(P

,0.01

),totalP

UFA

(P,

0.00

1),and

omega-6:om

ega-3

ratio

(P,

0.05

)at3and6mon

ths.

Other

grou

pswere

notsuccessful

inachievingtargets

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 43

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(30)

Lovejoy

2002

See“Carbo

hydrate

amou

nt:

mod

erateto

high

carboh

ydrate”

(88)

Mantzoros

2006

Cross-sectio

nal

Typ

e2

987wom

enMediterranean-

dietpattern

determ

ined

from

FFQ

(current

dietarydata

and4FF

Qs

from

thepast

10years)

Patternassessed

by0–

9po

int

scale:1po

int

givenifintake

abovemedian

forfish,fruit,

legu

mes,n

uts,

PUFA

:SFA

ratio,

vegetables,w

hole

grains;below

medianforred/

processedmeat

andifalcohol

intake

5–15

g/day

Glycemicmeasures:NS

HDL-Chigh

erin

highesttertile

ofadherence

toMediterranean

dietas

compared

tolower

2tertiles

(P5

0.03

)TGlower

inhigh

est

tertile

ofadherence

toMediterranean

dietas

compared

tolower

2tertiles

(P5

0.04

)

Nurses’HealthStud

yAdipon

ectin:

a.high

esttertile

ofadherence

toMediterranean

diet

over

10yearshad

adipon

ectinlevels

25.9%

higher

than

lowesttertile

controlling

forage

andtotalenergy

intake,P

,0.01

for

trendacross

tertiles

b.sign

ificant

independent

effects

byalcoho

l,nu

ts(12%

high

erlevelsin

highestnu

tintake

quintilecomparedto

lowest)andwho

legrains(22%

high

erlevelsin

high

est

intake

quintile

comparedto

lowest)

c.no

effectforfruit,

vegetables,fi

sh,

legumes,red/

processedmeats,

protein,

total

carboh

ydrate,total

fat,fiber,or

PUFA

/SFA

44 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(89)

Li20

09Prospective

coho

rtTyp

e2

6,30

9wom

enNutconsumption

from

FFQ

every2–

4years

between19

80and20

02

Dietary

intake

measure

ofnu

t(nuts

orpeanut

butter)

consumption

Glycemicmeasures:

notdo

ne

Increasingnu

tconsumptionwas

sign

ificantly

associated

withamore

favorable

plasmalip

idprofi

le,including

lower

LDL-C,

non-H

DL-C,

TC,and

apolipop

rotein-

B-10

0concentrations

Nurses’Health

Stud

yAfter

adjustmentfor

conv

ention

alCVD

risk

factors,

consum

ptio

nof

atleast5-servings/

weekof

nutsor

peanut

butter

(serving

size,2

8-g

[1oz.]fornu

tsand

16-g

[1tablespoo

n]

forpeanut

butter)

was

sign

ificantly

associated

with

alower

risk

ofCVD

(relativerisk

50.56

;95

%CI:0.36

–0.89

)Wholegrains

(48)

Vuk

san

2007

See “C

arbo

hyd

rate

type:

dietaryfiber”

(47)

Lu20

04See“Carbo

hydrate

type:d

ietary

fiber”

(54)

(56)

Qi2

006,

He20

10See“Carbo

hydrate

type:d

ietary

fiber”

(88)

Mantzoros

2006

See“N

uts”

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 45

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

Legumes

(91)

Pipe20

09RCTcrossover,

double

blind/57

days

each

(28-day

washo

ut

period

)

Typ

e2

29adults

Soyprotein

isolatevs.

milk

protein

isolate

supp

lements

Subjects

supp

lemented

usuald

ietwith

either

soyor

milk

protein

isolates.D

aily

packetsof

supp

lements

contained

200kcal;

8–9gCHO;

40gprotein

from

isolated

soyproteinor

milk

(caseinand

whey)

protein;

1gfat;1–

10mg

cholesterol;

1,40

0–1,60

0mg

calcium.T

hesoy

proteincontained

88mgisofl

avon

es(65%

genistein,

31%

daidzein,

4%glycitein)

and

themilk

protein

contained0mg

isofl

avon

es

Glycemicmeasures:NA

LDL-Cdecreased

withsoy

interventio

nfrom

2.95

to2.78

mmol/L

vs.m

ilk(P

50.04

)LD

L-C:HDL-Cratio

decreasedwithsoy

interventio

nvs.

milk

(P5

0.02

)

Bodyweigh

tdidno

tdiffer

betweenperiod

s

(92)

Gob

ert

2010

SeePipe20

09forstud

ydesign

details

Glycemicmeasures:NS

CVDrisk

measures:

notdo

ne

46 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(93)

Hermansen

2001

RCTcrossover,

doubleblind/

6weeks

(3-w

eek

washo

ut

period

)

Typ

e2

20adults

Soyprotein

vs.casein

Soyprotein

(Abalon):

50gisolated

soyprotein

(.16

5mg

isofl

avon

es)

and20

gcotyledon

fiber

vs.con

trol:5

0g

casein

and20

gcellu

lose

Glycemicmeasures:NS

TClower

after

Abalonthan

after

control(5.11

vs.5

.45mmol/L,

P,

0.01

)LD

L-Clower

after

Abalonthan

after

control(3.01

vs.

3.33

mmol/L,

P,

0.01

)

Weightcontrolled

(94)

Kim 20

05RCTparallel,

double

blind/13

weeks

Typ

e2

30adults

Soybean-

derivedpinitol

vs.lactose

Soybean-derived

pinitol:6

00-m

goraldo

se,twice

daily

vs.lactose:

twicedaily

Glycemicmeasures:NS

CVDrisk

measures:NS

Nosign

ificant

difference

inBM

Ibetweengrou

psat

baselin

e,andno

change

over

course

ofstud

y(50)

Cho 20

05See“Carbo

hydrate

type:d

ietary

fiber”

(95)

Fujita

2001

RCTparallel,

double

blind/3

mon

ths

Typ

e2

36adults

Ferm

ented

soybean-

derived

Tou

chiextract

vs.steam

edsoybean-

derived

control

Both

supplem

ents

incorporated

into

powdered

tea.Su

bjects

mixed

teawith

water

anddrank

1cupwith

each

meal.Eachcup

ofteacontained

0.3gsupp

lement

A1C

lower,T

ouchi

vs.con

trol

(5.6

vs.6

.2%,

P,

0.05

)FB

Glower,T

ouchi

vs.con

trol

(6.4

vs.

7.1mmol/L,

P,

0.05

)CVDrisk

measures:NS

Weight

uncontrolled,b

utno

significant

difference

between

grou

ps

(60)

Li20

05See“Fatam

ount”

(52)

DeNatale

2009

See“Carbo

hydrate

type:d

ietary

fiber”

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 47

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(96)

Jayagopal

2002

RCTcrossover,

doubleblind/

12weeks

each

(2-w

eekwasho

ut

period

)

Typ

e2

32po

stmenop

ausal

wom

en

Soy ph

ytoestrogen

vs.p

lacebo

243-kcalpacket

containing

30g

isolated

soy

proteinwith

132mg

isofl

avon

es(53%

genistein,3

7%daidzein,1

0%glycitein)

vs.

placebo

(microcrystalline

cellu

lose),

nokcal

A1C

decreased,

soyvs.p

lacebo

(20.64

vs.1

1.08

%,

P5

0.04

8)Fastingserum

insulin

decreased,

soyvs.

placebo(2

8.09

vs.

19.92

%,P

50.00

6)TCdecreased,

soyvs.

placebo(2

4.07

vs.

12.83

%,P

50.00

4)LD

L-Cdecreased,

soyvs.p

lacebo

(27.09

vs.1

5.35

%,

P5

0.00

1)

Weight

uncontrolled,b

utno

change

inweightdu

ring

stud

yCaloriedifference

betweensoyand

placebowas

aconfou

nding

factor

astherewas

noassessmentof

dietor

statistical

controlfor

calorie

intake

HOMA-IRdecreased,

soyvs.p

lacebo

(26.27

vs.1

14.7%,

P5

0.00

3)(97)

Gon

zález

2007

RCTcrossover,

doubleblind/

12weeks

each

(4-w

eek

washo

ut

period

)

Typ

e2

26po

stmenop

ausal

wom

en

Isofl

avon

esvs.p

lacebo

Tabletwith

132mg

isofl

avon

es(53%

genistein,3

7%diadzein,1

0%glycitein)

vs.

placebotablet

(cellulose)

Glycemicmeasures:NS

CVDrisk

measures:NS

Weightno

tcontrolled

48 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(98)

How

es20

03RCTcrossover,

doubleblind/

4weeks

each

(4-w

eek

washo

ut

period

)

Typ

e2

16po

stmenop

ausal

wom

en

Isofl

avon

esfrom

red

clover

vs.

control

2isofl

avon

etablets(25mg

form

onon

etin,

2.5mgbiochanin,

,1mggenistein

anddaidzein

per

tablet)vs.con

trol

tablets

Glycemicmeasures:NS

CVDrisk

measures:NS

Weightno

tcontrolled,

butno

sign

ificant

differencesbetw

een

period

sNodescriptio

nof

contentof

control

tablets(exceptno

isofl

avon

es)

Bloo

dpressure

and

endo

thelialfunctio

nweremainou

tcom

esstud

ied

Vegetablesan

dfruits

(99)

Sobenin

2008

RCTparallel,

double

blind,

4arms/4

weeks

Typ

e2

34adults

Garlic

powder

(Allicor)vs.

control

Group

1:mon

otherapy

with30

0mg

ofAllicortwice

adayor

control

withoral

diabetes

medications

discon

tinu

edGroup

2:same

exceptthatoral

diabetes

medications

continued

Serum

fructosam

ine

decreased

sign

ificantly,

Allicorvs.

control,bo

thmon

otherapy

andcombined

therapy(P

,0.05

)CVDrisk

measures:NS

Weightno

tcontrolled

Group

1:FB

G#8

mmol/L;G

roup

2:FB

G.8mmol/L

Con

trol

isno

tdescribed,somay

notbe

aplacebo

TGdecreased

sign

ificantlyin

Allicorgrou

p,baselin

eto

endof

stud

y,bo

thmon

otherapy

and

combinedtherapy

(P,

0.05

)(52)

DeNatale

2009

See“Carbo

hydrate

type:d

ietary

fiber”

(88)

Mantzoros

2006

See“N

uts”

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 49

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

Dairy

(100

)Moh

amad

2009

RCTparallel/

16weeks

Typ

e1

54youn

gadults

(17–

20years)

Cam

elmilk

Con

trol

grou

preceived

usual

care

vs.u

sual

care

150

0mL

daily

ofcamel

milk

Cam

elmilk

grou

pvs.u

sualcare

grou

p:A1C

,FB

G,anddaily

insulin

dose

sign

ificantly

lower

(7.16

vs.9

.59%

,99

vs.2

27mg/dL,

23vs.4

8un

its,

respectively),

allP

,0.00

1CVDrisk

measures:NS

Weightno

tcontrolled(BMI

sign

ificantlyhigh

erin

camelmilk

grou

pvs.u

sualcare

grou

p)(24.3vs.18.4kg/m

2)

(101

)Sh

ahar

2007

Ancillary

stud

yof

anRCT

Typ

e2

259adults

Dairy

calcium

3isocaloricdiets

wereassessed

forcalcium

intake:

1.mixed

GICHO

2.lower

GI

3.mod

ified

Mediterranean

Glycemicmeasures

(A1C

,FBG

):NS

CVDrisk

measures:NS

Stud

yfoun

dno

association

betweendairy

calcium

intake

andother

diabetes/

CVDdiseaseindexes

(91)

Pipe 2009

See“Legum

es”

(92)

Gob

ert

2010

See“Legum

es”

(93)

Hermansen

2001

See“Legum

es”

(94)

Kim

2005

See“Legum

es”

Meats,p

oultry,andfish

(81)

Gross 2002

See“Protein”

50 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

numbe

rAuthor/

year

Studytype/

duration

Diabetes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(84)

deMello

2006

See“Protein”

(102

)Qi2

007

Prospective

coho

rtType2

6,16

1wom

enRed

meatintake

Red

meatand

hemeiron

(intake

assessed

ascumulative

averagefrom

FFQs

1980

,198

4,19

86,

1990

,199

4,and

1998

;FFQ

asked

abou

tintake

frequencyand

amou

ntover

past

year;red

meat

definedasbeef,pork,

orlambasmaindish,

beefas

asandw

ichor

mixed

dish,

hambu

rger,h

otdo

g,processed

meat,or

bacon

Glycemicmeasures:

notdo

ne

CVDrisk

measures:

notdo

ne

Nurses’HealthStudy

Highhemeiron

andredmeatintakes

wereassociated

with

high

intakesof

saturatedfat,low

intakesofcerealfiber

andvitamin

C,and

lowdietaryGL

After

adjustmentfor

ageandBM

I,high

intakesof

both

heme

iron

andredmeat

wereassociated

with

asign

ificantly

increasedrisk

offatal

CHD,coron

ary

revascularization

,andtotalC

HD

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 51

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(103

)Möllsten

2001

Case-control

Typ

e1with

micro-/

macro-

albu

minuria

75case

and

225control,

youth

Fish

fatand

protein

Fish

intake:

FFQ

forpast

12mon

ths

Glycemicmeasures:

notdo

ne

CVDrisk

measures:

notdo

ne

Highconsumersof

fish

protein(m

ean

intake

9.35

gfish

protein/day,i.e.,

approxim

ately53

gfish/day)hadlower

oddsratios

for

microalbu

minuria

than

individu

als

consum

ingless

fish

protein(m

ean2.72

g/day)

Whenfish

proteinand

fatwereadjusted

for

each

other,a

high

intake

offish

protein

butn

otoffish

fatw

asstill

sign

ificantly

associated

with

adecrease

inthe

risk

for

microalbu

minuria

52 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

Med

iterraneandiets

(104

)Esposito

2009

RCTparallel/

4years

Typ

e2

195adults

Lower

CHO

Mediterranean

dietvs.low

er-

fatdiet

(American

HeartAssociation

guidelines)

Lower-CHO

Mediterranean-

stylediet:richin

vegetables,w

hole

grains,with

poultryandfish

replacingred

meats;goal,

50%

CHO

and$30

%fat;achieved

44.2%

CHO,1

0%SF

A,

17.6%

MUFA,

11.5%

PUFA,

18%

proteinvs.

Lower-fatdiet:rich

inwho

legrains,

restricted

inadded

fats,sweets,and

high

-fatsnacks;

goal,30

%fat,

,10

%SF

A;

achieved:5

1.8%

CHO,9

.4%

SFA,

12.4%

MUFA,

7.6%

PUFA

,17

.9%

protein

A1C

andFB

Gsign

ificantly

lower

inlower-

CHO

Mediterranean

dietvs.low

er-fat

diet,all4years

HDL-Cincreased

sign

ificantlyand

TGdecreased

sign

ificantly,lower-

CHO

Mediterranean

dietvs.low

er-fatdiet,

all4

years

Weight-lossstud

yIncrease

infatin

lower-CHO

Mediterranean

diet

was

from

30–50

goliveoil

Prim

aryou

tcom

e(tim

eto

antih

yperglycem

ictherapy):after

4years,44

%of

patientsin

lower-CHO

Mediterranean–diet

grou

prequ

ired

treatm

entvs.7

0%in

lower-fat-dietgrou

p

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 53

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(105

)Karantonis

2006

RCTparallel/

4weeks

Typ

e2

45adults

Mod

ified

Mediterranean

fast-foo

d–type

diet(usingfood

shighestin

platelet

anti-aggregatin

gactiv

ity)vs.

control

(traditio

nal

Greek

Mediterranean

fast-foo

ddiet)

Mod

ified

fast

food

sincluded

macaron

iand

cheese,chicken

fillet,pitabu

rger,

chef’ssalad,

potato

salad:5

0%CHO,3

8%fat

(13%

SFA,1

7%MUFA,8

%PU

FA),

16.5%

protein,

22gfiber(end

-of-

stud

yvalues)vs.

controld

iet

includedfastfood

ssuch

asroasted

meat/fish

with

potatoes,b

eef

andmacaron

i,carrot

andcabb

age

salad:5

3%CHO,

24%

fat(12%

SFA,7

%MUFA,

4%PU

FA),25

%protein,

16g

fiber(end

-of-

stud

yvalues)

Glycemicmeasures:NS

CVDrisk

measures:NS

Seecommentsin

Antonop

oulou

2006

54 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(106

)Anton

o-po

ulou

2006

RCTparallel/

4weeks

Typ

e2

47adults

Mod

ified

Greek

Mediterranean

dietusingfood

shighestin

plateletactivating

factor

antagonists

vs.con

trol

(typ

icalGreek

Mediterranean

diet)

Mod

ified

diet

includedfood

ssuch

ascodfi

shsoup

,beefand

friedpo

tato,

chickenand

gumbo

,and

lettucesalad.

Tradition

aldietincluded

food

ssuch

asbo

iledchicken

andrice,roasted

fish

andpo

tato

Mod

ified:5

0%CHO,3

8%fat

(10%

SFA,2

1%MUFA,4

%PU

FA),15

%protein(prescribed)

vs.typ

ical:5

0–55

%CHO,2

0–25

%fat

(7%

SFA,1

2%MUFA,2

.4%

PUFA

),25

%protein

Glycemic

measure

(FBG):NS

CVDrisk

measures:NS

Food

swere

provided

toall

participantsdu

ring

thestud

y,isocaloric

totypicaldiets

previous

tostud

ySign

ificant

reductio

nin

platelet-activating

factor

andadenosine

5diph

osph

ate-

indu

cedaggregation

ofplateletson

the

mod

ified

dietbu

tno

change

onthe

typicald

iet

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 55

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(107

)Aronis

2007

RCTparallel/

4weeks

Typ

e2

35adults

Fast-foo

dMediterranean–

type

diet(m

eals

withmost

potentin

vitro

antioxidative

activ

ity)vs.

control

(traditio

nal

Greek

fast-

food

diet)

Mediterranean

fastfood

sincluded

macaron

iwith

cheese

and

tomatopaste,

hambu

rger,

chef’ssalad,

kidneybean

salad:5

3%CHO,

43%

fat(15%

SFA,1

9%MUFA

,9%

PUFA

),16

%protein,

23g

fiber(end

-of-stud

yvalues)vs.con

trol:

53%

CHO,2

4%fat(12%

SFA,7

%MUFA,4

%PU

FA),

25%

protein,

16g

fiber(end

-of-stud

yvalues)

Glycemicmeasures:NS

CVDrisk

measures:NS

Food

swere

provided

forbo

thgrou

psof

subjects,

isocaloricto

typical

dietsprevious

tostud

yDiabetesoralagents

wereun

changed

during

thestudy

Plasmaoxidationlag

timeincreased

sign

ificantlyin

fast-

food

grou

pbu

tdid

notchange

incontrolgroup

(52)

DeNatale

2009

See“Fiber”

56 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

(108

)Ciccarone

2003

Case-control

Typ

e2

144cases

withPA

D/288

controls(no

macrovascular

complications,

adults)

Mediterranean

dietscoring

ofaFF

Q

Scoring:1po

int

forvegetables

($3tim

es/week),

fruits($

7tim

es/

week),fi

sh($

1times/week),

oliveoil(1–

2times/day),

alcoho

l(#3

glasseswine/day),

eggs

(#2tim

es/

week),m

eat(#

2times/week),

processedmeat

(0tim

es/week),

cheese

(#2

times/week)

Glycemicmeasure

(A1C

):NS

CVDrisk

measures:

notdo

ne

BMIcontrolledin

multiv

ariate

analyses

Inmultiv

ariateanalysis,

highestdietaryscore

(111

points)

sign

ificantlyand

independently

associated

with

56%

reductio

nin

risk

ofPA

D

(109

)Marfella

2006

RCTparallel/

12mon

ths

Typ

e2

115adults,

post-M

IRed

wine

vs.con

trol

Red

wine,4-oz.

daily

vs.

control(no

alcoho

l)Bo

thgrou

pscoun

seled

onMediterranean

diet(m

eanintake

178gCHO,9

gSF

A,1

7gMUFA,

8gPU

FA,7

3g

protein,

lower

sodium,h

igher

fiber)

Glycemicmeasures:

NS;

however,

fastinginsulin

andHOMAwere

high

erin

wine

grou

pvs.con

trol

(P,

0.05

)HDL-Chigh

erin

wine

grou

pvs.con

trol

(P,

0.05

)

Weightno

tcontrolled;

however,

weightloss

not

statistically

different

betweengrou

ps

(88)

Mantzoros

2006

See“N

uts”

Nurses’Health

Stud

y

care.diabetesjournals.org DIABETES CARE, VOLUME 35, FEBRUARY 2012 57

Wheeler and Associates

Supplemen

tary

Tab

le1d

Con

tinu

ed

Ref.

number

Author/

year

Studytype/

duration

Diabe

tes

n‡Com

parison

summary

Interven

tion

detail{

dietary

variab

leof

interest

for

observational

studies

Sign

ificant

results**

Com

men

ts/study

limitations#

Vegetariandiets

(21)

Barnard

2009

See“Carbo

hydrate

amou

nt:

mod

erateto

high

carboh

ydrate”

(110

)Turner-

McG

rievy

2008

SeeBarnard

2009

for

stud

ydetails

Both

vegan

andtraditional

dietssign

ificantly

improved

intakesof

energy,totalfat,

transfat,cholesterol,

andsodium

but

werebelow

recommended

intakesforvitamin

D,E

,calcium,and

potassium

Vegan

dietim

proved

intake

offiber,folate,

magnesium,and

vitaminsA,C

,K(81)

Gross

2002

See“Protein”

(84)

deMello

2006

See“Protein”

A1C

,glycatedhemoglobin;A

ER(orUAER),albu

min

excretionrate(orurinaryalbu

min

excretionrate);ALA

,alpha-linolenicacid;A

UC,areaun

derthecurve;CACTI,Coron

aryArteryCalcification

inTyp

e1Diabetes

study;C

GMS,continuou

sglucosemon

itoringsystem

;CHD,coron

aryheartd

isease;C

HO,carbo

hydrate;C

RP,

C-reactiveprotein;C

VD,cardiovasculardisease;DHA,d

ocosahexaenoicacid;D

PP,D

iabetesPrevention

Program;EASD

,Europ

eanAssociation

forthe

Stud

yofDiabetes;EPA

,eicosapentaenoicacid;FFQ

,foo

dfrequency

questio

nnaire;GFR,glomerularfi

ltrationrate;G

I,glycem

icindex;GL,glycem

icload;G

LP-1,glucagon-

likepeptid

e1;HCHF,

high

ercholesterol/h

igherfiber;HDL-C,H

DLcholesterol;HFL

C,h

igherfat/lowercholesterol;HOMA,h

omeostasismod

elassessment;IAUC,incrementalareaun

derthecurve;ITT,intention

totreat;LD

L-C,LD

Lcholesterol;LF

HC,lower

fat/higher

carboh

ydrate;Lp

B:C,apoB

-con

taininglip

oprotein;MCHF,mod

eratecarboh

ydrate/higherfiber;MCLF

,mod

eratecarboh

ydrate/lo

wer

fiber;MI,myocardial

infarction

;MUFA

,mon

ounsaturated

fattyacid;N

CEP,

NationalC

holesterol

Edu

catio

nProgram;N

HLB

I,NationalH

eart,L

ung,andBloo

dInstitu

te;N

S,no

tsign

ificant;OGTT,o

ralglucose

tolerancetest;P

AD,p

e-riph

eralarterialdisease;PG

,plasm

aglucose;P

PG,p

ostprandialglucose;PU

FA,p

olyu

nsaturated

fattyacid;R

CT,random

ized

controlledtrial;TC,totalcholesterol;TG,triglyceride;TNF,

tumor

necrosisfactor;SFA

,saturatedfattyacid;U

AER,u

rinaryalbu

min

excretionrate.‡

,num

berof

subjectscompleting

study.{

,%CHO,fat,and

/orproteinreferto

%kcalfrom

CHO,fat,and

/orprotein;

goal→achieved.

**,results

areon

lypresentedforRCTsifthesign

ificance

isbetw

eengrou

ps;for

one-armed

studies,ifthe

sign

ificance

isbetw

eenbeginn

ingandend;

glycem

icmeasures,in

general(A1C

,FBG

,PPG

);CVDrisk

measures,in

general(TC,

LDL-C,H

DL-C,T

G).#,

retentionratedeterm

ined

tobe

alim

itationif,80

%.*

,insignificant

whenaccompanied

byenergy

restriction.

†,w

eigh

tloss/weightmaintenance.

58 DIABETES CARE, VOLUME 35, FEBRUARY 2012 care.diabetesjournals.org

Medical nutrition therapy in managing diabetes