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. Author manuscript; available in PMC: 2016 Dec 1.
Published in final edited form as: Lancet Diabetes Endocrinol. 2015 Oct 30;3(12):968–979. doi: 10.1016/S2213-8587(15)00367-8

Table 1.

Randomized trials of low-fat versus other dietary interventions of at least 1 year duration among adults, included in the meta-analysis.

Trial Name N randomized;
Population
Country Weight
loss
goal
Low-fat diet(s)
intervention
Comparator diet(s)
intervention
Follow-
up
duration
(years)
A to Z (36) 311; Overweight,
premenopausal
women
US Yes [1] LEARN (reduced
calorie); [2] Ornish (<10%
fat; reduced calorie)
[1] Atkins low-carbohydrate;
[2] Zone (30% fat; reduced
calorie)
1
Anderson 1992
(11)
117; Moderate
hypercholesterolemia
US Maintain American Heart Association
Phase II (25% fat)
Usual diet 1
Barnard 2009
(14)
99; Type 2 diabetes US Yes Vegan (10% fat) American Diabetes
Association Diet 2003 (30%
fat; reduced calorie)
1.4
Bazzano 2014
(37)
148; Obese US Yes National Cholesterol
Education Program (<30%
fat)
Low carbohydrate 1
Bertz 2012 (38) 68; Breastfeeding
mothers
Sweden Yes Nordic Nutrition Guidelines
(<30% fat; reduced calorie)
Usual diet 1
Boyd 1990 (29) 295; Women at high
breast cancer risk
Canada Maintain 15% fat Canadian Food Guide (No
fat intake advice)
1
Breast Cancer
Prevention
Program (23)
194; Women at high
breast cancer risk
US No 15% fat Usual diet 1
Brehm 2009
(15)
124;
Overweight/obese
with type 2 diabetes
US Yes High carbohydrate (25% fat;
reduced calorie)
High mono-unsaturated fat
(40% fat; reduced calorie)
1
BRIDGES (7) 172; Women with
recent breast cancer
US No Nutrition Education Program
(20% fat)
Usual diet 1
Brinkworth
2009 (39, 40)
118; At risk for
metabolic syndrome
Australia Yes 30% fat (reduced calorie) Atkins low-carbohydrate
(61% fat; reduced calorie)
1
CALERIE
Phase I (41)
34; Overweight US Yes High glycemic index, food
provided (20% fat; reduced
calorie)
Low glycemic index, food
provided (30% fat; reduced
calorie)
1
Canadian Diet
and Breast
Cancer
Prevention
Study (30)
4690; Women at high
breast cancer risk
Canada Maintain 15% fat Canadian Food Guide (No
fat intake advice)
10
Dansinger 2005
(42)
160; At risk for
cardiovascular
disease
US Yes Ornish (<10% fat) [1] Atkins low-carbohydrate;
[2] Zone (30% fat); [3]
Weight Watchers (reduced
calorie)
1
Davis 2009 (16) 105; Type 2 diabetes US Yes Diabetes Prevention
Program diet (25% fat)
Atkins low-carbohydrate 1
DEER (12) 377;
Hypercholesterolemia
US No National Cholesterol
Education Program (<30%
fat)
Usual diet 1
The Dietary
Alternatives
Study (13)
508; Men with
hypercholesterolemia
US No [1] 26% fat; [2] 22% fat; [3]
18% fat
30% fat 1
DIRECT (17) 322; Type 2 diabetes,
cardiovascular
disease, or obese
Israel Yes American Heart Association
(30% fat; reduced calorie)
[1] Mediterranean diet (35%
fat; reduced calorie); [2]
Atkins low-carbohydrate
2
Ebbeling 2007
(43)
73; Obese young
adults
US Yes 20% fat Low glycemic-index
carbohydrates (35% fat)
1.5
Elhayany 2010
(18)
259; Type 2 diabetes Israel Yes [1] American Diabetes
Association 2003 (30% fat;
reduced calorie); [2] Low-fat
Mediterranean (30% fat;
reduced calorie)
Low carbohydrate
Mediterranean diet (45%
fat; reduced calorie)
1
Esposito 2009
(19)
215; Type 2 diabetes Italy Yes American Heart Association
2000 (<30% fat; reduced
calorie)
Mediterranean diet (>30%
fat; reduced calorie)
4
Foster 2003
(44)
63; Obese US Yes 25% fat (reduced calorie) Atkins low-carbohydrate 1
Foster 2010
(45)
307; Obese US Yes 30% fat (reduced calorie) Atkins low-carbohydrate 2
Guldbrand 2012
(20)
61; Type 2 diabetes Sweden Yes <30% fat (reduced calorie) Low-carbohydrate (50% fat;
reduced calorie)
2
Harvey-Berino
1999 (46)
80;
Overweight/obese
US Yes 20% fat Low-calorie 1.5
Iqbal 2010 (21) 144; Type 2 diabetes,
obese
US Yes <30% fat (reduced calorie) Low-carbohydrate 2
Keogh 2007
(47)
44;
Overweight/obese
Australia Yes 20% fat (reduced calorie) Low-carbohydrate (27% fat;
reduced calorie)
1
Klemsdal 2010
(48)
202; Metabolic
syndrome
Norway Yes 30% fat (reduced calorie) Low glycemic load (35–40%
fat; reduced calorie)
1
Kristal 2005
(49)
93;
Overweight/obese
with esophageal
metaplasia
US Yes 20% fat (reduced calorie) Usual diet 3
Lapointe 2010
(50)
68;
Overweight/obese
postmenopausal
women
Canada Yes Reduce fat intake Increase fruits and
vegetables
1.5
Lim 2010 (51) 113; High
cardiovascular
disease risk
Australia Yes Food provided (10% fat;
reduced calorie)
[1] Low-carbohydrate, food
provided (60% fat; reduced
calorie); [2] High
unsaturated fat, food
provided (30% fat; reduced
calorie); [3] Usual diet
1.25
McAuley 2006
(52)
96; Women
overweight/obese
with insulin
resistance
New
Zealand
Yes Diabetes and Nutrition
Study Group of the
European Association for
the Study of Diabetes
(<30% fat)
[1] low carbohydrate Atkins
diet; [2] Zone diet (30% fat)
1
McManus 2001
(53)
101; Overweight US Yes 20% fat (reduced calorie) 35% fat (reduced calorie) 1.5
Nutrition and
Exercise in
Women Study
(54)
439;
Postmenopausal
overweight/obese
women
US Yes <30% fat (reduced calorie) Usual diet 1
Nutrition and
Breast Health
Study (31)
122; Premenopausal
women at risk of
breast cancer
US Maintain (1) 15% fat; (2) High fruits
and vegetables (15% fat)
(1) Usual diet; (2) High fruits
and vegetables
1
Pilkington 1960
(24)
58; Men with
ischemic heart
disease
UK No 20 g fat/day Increase unsaturated fats 1.5
Polyp
Prevention Trial
(25)
2079; Recent
colorectal adenoma
US No 20% fat Usual diet 3.1
Pounds Lost
Trial (55)
811;
Overweight/obese
US Yes [1] 20% fat (reduced
calorie); [2] high protein
(20% fat; reduced calorie)
[1] 40% fat (reduced
calorie); [2] high protein
(40% fat; reduced calorie)
2
PREDIMED
(26)
7447; High
cardiovascular
disease risk
Spain No Reduce fat intake Mediterranean Diet + [1]
increase extra-virgin olive
oil intake, [2] mixed nuts
intake
4.8
PREMIER (56) 810; Prehypertension US Yes DASH (<25% fat; reduced
calorie)
30% fat (reduced calorie) 1.5
Shah 1996 (57) 122; Obese women US Yes 20 g fat/day 30% fat (reduced calorie) 1
SMART Study
(58)
200;
Overweight/obese
Germany Yes German Nutrition Society
(30% fat; reduced calorie)
Low-carbohydrate (35% fat;
reduced calorie)
1
Stern 2004 (59,
60)
132; Morbidly obese US Yes NHLBI (30% fat; reduced
calorie)
Low-carbohydrate 1
Swinburn 2001
(28)
176; Glucose
intolerance
New
Zealand
No Reduce fat Usual diet 5
Tapsell 2004
(22)
63; Type 2 diabetes Australia No 27% fat 37% fat 1
Tehran Lipid
and Glucose
Study (61)
100;
Overweight/obese
Iran Yes 20% fat (reduced calorie) 30% fat (reduced calorie) 1.2
Turner-
McGrievy 2007
(62)
64;
Overweight/obese
postmenopausal
women
US Yes Vegan (10% fat) National Cholesterol
Education Program (<30%
fat)
2
Viegener 1990
(63)
85;
Overweight/obese
women
US Yes 15–25% fat (reduced calorie) 30% fat (reduced calorie) 1
Women’s
Health Initiative
Dietary
Modification
Trial (32)
48835;
Postmenopausal
women
US Maintain 20% fat Usual diet 7.5
Women’s
Health Trial
Vanguard Study
(27)
303; Women at high
breast cancer risk
US No 20% fat Usual diet 2
Women’s
Healthy Eating
and Living
(WHEL) (9)
3088; Women with
previous breast
cancer
US No 15–20% fat USDA guidelines (<30% fat) 7.3
Women’s
Intervention
Nutrition Study
(WINS) (8)
2437; Women with
breast cancer
US No 15% fat General counseling on
nutritional adequacy
5
Women’s
Intervention
Nutrition Study
(WINS)
Feasibility (10)
290; Women with
postmenopausal
breast cancer
US No 20% fat General counseling on
nutritional adequacy
1.5
Wood 1991 (64) 294;
Overweight/obese
US Yes National Cholesterol
Education Program (<30%
fat; reduced calorie)
Usual diet 1