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Meta-Analysis
. 2020 Jun 1;6(6):CD013636.
doi: 10.1002/14651858.CD013636.

Effects of total fat intake on body fatness in adults

Lee Hooper  1 , Asmaa S Abdelhamid  1 , Oluseyi F Jimoh  1 , Diane Bunn  1 , C Murray Skeaff  2
Affiliations
Meta-Analysis

Effects of total fat intake on body fatness in adults

Lee Hooper et al. Cochrane Database Syst Rev. .

Abstract

Background: The ideal proportion of energy from fat in our food and its relation to body weight is not clear. In order to prevent overweight and obesity in the general population, we need to understand the relationship between the proportion of energy from fat and resulting weight and body fatness in the general population.

Objectives: To assess the effects of proportion of energy intake from fat on measures of body fatness (including body weight, waist circumference, percentage body fat and body mass index) in people not aiming to lose weight, using all appropriate randomised controlled trials (RCTs) of at least six months duration.

Search methods: We searched CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) to October 2019. We did not limit the search by language.

Selection criteria: Trials fulfilled the following criteria: 1) randomised intervention trial, 2) included adults aged at least 18 years, 3) randomised to a lower fat versus higher fat diet, without the intention to reduce weight in any participants, 4) not multifactorial and 5) assessed a measure of weight or body fatness after at least six months. We duplicated inclusion decisions and resolved disagreement by discussion or referral to a third party.

Data collection and analysis: We extracted data on the population, intervention, control and outcome measures in duplicate. We extracted measures of body fatness (body weight, BMI, percentage body fat and waist circumference) independently in duplicate at all available time points. We performed random-effects meta-analyses, meta-regression, subgrouping, sensitivity, funnel plot analyses and GRADE assessment.

Main results: We included 37 RCTs (57,079 participants). There is consistent high-quality evidence from RCTs that reducing total fat intake results in small reductions in body fatness; this was seen in almost all included studies and was highly resistant to sensitivity analyses (GRADE high-consistency evidence, not downgraded). The effect of eating less fat (compared with higher fat intake) is a mean body weight reduction of 1.4 kg (95% confidence interval (CI) -1.7 to -1.1 kg, in 53,875 participants from 26 RCTs, I2 = 75%). The heterogeneity was explained in subgrouping and meta-regression. These suggested that greater weight loss results from greater fat reductions in people with lower fat intake at baseline, and people with higher body mass index (BMI) at baseline. The size of the effect on weight does not alter over time and is mirrored by reductions in BMI (MD -0.5 kg/m2, 95% CI -0.6 to -0.3, 46,539 participants in 14 trials, I2 = 21%), waist circumference (MD -0.5 cm, 95% CI -0.7 to -0.2, 16,620 participants in 3 trials; I2 = 21%), and percentage body fat (MD -0.3% body fat, 95% CI -0.6 to 0.00, P = 0.05, in 2350 participants in 2 trials; I2 = 0%). There was no suggestion of harms associated with low fat diets that might mitigate any benefits on body fatness. The reduction in body weight was reflected in small reductions in LDL (-0.13 mmol/L, 95% CI -0.21 to -0.05), and total cholesterol (-0.23 mmol/L, 95% CI -0.32 to -0.14), with little or no effect on HDL cholesterol (-0.02 mmol/L, 95% CI -0.03 to 0.00), triglycerides (0.01 mmol/L, 95% CI -0.05 to 0.07), systolic (-0.75 mmHg, 95% CI -1.42 to -0.07) or diastolic blood pressure(-0.52 mmHg, 95% CI -0.95 to -0.09), all GRADE high-consistency evidence or quality of life (0.04, 95% CI 0.01 to 0.07, on a scale of 0 to 10, GRADE low-consistency evidence).

Authors' conclusions: Trials where participants were randomised to a lower fat intake versus a higher fat intake, but with no intention to reduce weight, showed a consistent, stable but small effect of low fat intake on body fatness: slightly lower weight, BMI, waist circumference and percentage body fat compared with higher fat arms. Greater fat reduction, lower baseline fat intake and higher baseline BMI were all associated with greater reductions in weight. There was no evidence of harm to serum lipids, blood pressure or quality of life, but rather of small benefits or no effect.

Trial registration: ClinicalTrials.gov NCT01414062 NCT02353416 NCT02368405 NCT02396264 NCT01798719 NCT00438425.

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Conflict of interest statement

AA: the World Health Organization (WHO) provided funding to the University of East Anglia towards the cost of carrying out the update of this systematic review, which partly covered the salary of AA. AA received funding from WHO to cover expenses associated with attendance at meetings of the NUGAG subgroup on diet and health.

OFJ: the World Health Organization (WHO) provided funding to the University of East Anglia towards the cost of carrying out the update of this systematic review, which partly covered the salary of OFJ.

DB: none known.

LH: the World Health Organization (WHO) provided funding to the University of East Anglia towards the cost of carrying out the update of this systematic review, which partly covered the salary of LH. LH is a member of the WHO NUGAG subgroup on diet and health and received funding from WHO to cover expenses associated with attendance at meetings of the NUGAG subgroup on diet and health.

CMS: none known.

Figures

1
1
Study flow diagram
2
2
'Risk of bias' summary: review authors' judgements about each methodological quality item for each included adult and child RCT comparison.
3
3
Funnel plot of comparison: 1 Fat reduction versus usual fat diet, outcome: 1.1 Weight, kg.
1.1
1.1. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 1: Weight, kg
1.2
1.2. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 2: BMI, kg/m2
1.3
1.3. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 3: Waist circumference, cm
1.4
1.4. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 4: Body fat, %
1.5
1.5. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 5: Total cholesterol, mmol/L
1.6
1.6. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 6: LDL cholesterol, mmol/L
1.7
1.7. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 7: HDL cholesterol, mmol/L
1.8
1.8. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 8: Triglycerides, mmol/L
1.9
1.9. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 9: Total cholesterol/HDL
1.10
1.10. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 10: Systolic blood pressure, mmHg
1.11
1.11. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 11: Diastolic blood pressure, mmHg
1.12
1.12. Analysis
Comparison 1: Lower fat vs higher fat diet, Outcome 12: Quality of life
2.1
2.1. Analysis
Comparison 2: Lower fat vs higher fat diet on body weight, sensitivity analyses, Outcome 1: Weight, kg SA fixed effects
2.2
2.2. Analysis
Comparison 2: Lower fat vs higher fat diet on body weight, sensitivity analyses, Outcome 2: Weight, kg SA including only RCTs at low summary RoB
2.3
2.3. Analysis
Comparison 2: Lower fat vs higher fat diet on body weight, sensitivity analyses, Outcome 3: Weight, kg SA excluding the largest trial, WHI
2.4
2.4. Analysis
Comparison 2: Lower fat vs higher fat diet on body weight, sensitivity analyses, Outcome 4: Weight, kg SA excluding RCTs not free of systematic differences in care
2.5
2.5. Analysis
Comparison 2: Lower fat vs higher fat diet on body weight, sensitivity analyses, Outcome 5: Weight, kg SA excluding studies not free of dietary differences other than fat
2.6
2.6. Analysis
Comparison 2: Lower fat vs higher fat diet on body weight, sensitivity analyses, Outcome 6: Weight, kg SA excluding studies with potential compliance problems
2.7
2.7. Analysis
Comparison 2: Lower fat vs higher fat diet on body weight, sensitivity analyses, Outcome 7: Weight, kg including partial data
3.1
3.1. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 1: Weight, kg Subgrouping by trial duration
3.2
3.2. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 2: Weight, kg Subgrouping by baseline fat intake
3.3
3.3. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 3: Weight, kg Subgrouping by decade of first publication
3.4
3.4. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 4: Weight, kg Subgrouping by sex
3.5
3.5. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 5: Weight, kg Subgrouping by difference in %E from fat between control & reduced fat groups
3.6
3.6. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 6: Weight, kg Subgrouping by achieving < 30%E from fat
3.7
3.7. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 7: Weight, kg Subgrouping by type of intervention
3.8
3.8. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 8: Weight, kg Subgrouping by lower fat arm fat goal
3.9
3.9. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 9: Weight, kg Subgrouping by mean BMI at baseline
3.10
3.10. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 10: Weight, kg Subgrouping by baseline health status
3.11
3.11. Analysis
Comparison 3: Lower fat vs higher fat diet on body weight, subgrouping, Outcome 11: Weight, kg Subgrouping by assessed energy reduction
See this image and copyright information in PMC

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    1. Sass DA, Schoen RE, Weissfeld JL, Weissfeld L, Thaete FL, Kuller LH, et al. Relationship of visceral adipose tissue to recurrence of adenomatous polyps. American Journal of Gastroenterology 2004;99(4):687-93. - PubMed
RISCK 2010 {published data only}
    1. Alsaleh A, O'Dell SD, Frost GS, Griffin BA, Lovegrove JA, Jebb SA, et al. Interaction of PPARG Pro12Ala with dietary fat influences plasma lipids in subjects at cardiometabolic risk. Journal of Lipid Research 2011;52(12):2298-303. - PMC - PubMed
    1. Alsaleh A, Sanders TA, O'Dell SD. Effect of interaction between PPARG, PPARA and ADIPOQ gene variants and dietary fatty acids on plasma lipid profile and adiponectin concentration in a large intervention study. Proceedings of the Nutrition Society 2012;71(1):141-53. - PubMed
    1. Fava F, Gitau R, Griffin BA, Gibson GR, Tuohy KM, Lovegrove JA. The type and quantity of dietary fat and carbohydrate alter faecal microbiome and short-chain fatty acid excretion in a metabolic syndrome 'at-risk' population. International Journal of Obesity (London) 2013;37(2):216-23. - PubMed
    1. Griffin BA, Walker CG, Jebb SA, Moore C, Frost GS, Goff L, et al. APOE4 genotype exerts greater benefit in lowering plasma cholesterol and apolipoprotein B than wild type (E3/E3), after replacement of dietary saturated fats with low glycaemic index carbohydrates. Nutrients 2018;10(10):E1524. [DOI: 10.3390/nu10101524] - DOI - PMC - PubMed
    1. ISRCTN29111298. Impact of the amount and composition of dietary fat and carbohydrate on metabolic syndrome and cardiovascular disease risk. doi.org/10.1186/ISRCTN29111298 (received 16 Aug 2005).
Rivellese 1994 {published and unpublished data}
    1. Rivellese AA, Auletta P, Marotta G, Saldalamacchia G, Giacoo A, Mastrilli V, et al. Long term metabolic effects of two dietary methods of treating hyperlipidaemia. BMJ 1994;308:227-31. - PMC - PubMed
Sarkkinen Low & Mod 1993 {published and unpublished data}
    1. Makinen E, Uusitupa MI, Pietinen P, Aro A, Penttila I. Long term effects of three fat modified diets on serum lipids in free living hypercholesterolaemic subjects (abstract). European Heart Journal 1991;12:162.
    1. Sarkkinen E. Long-Term Feasibility and Effects of Three Different Fat-Modified Diets in Free-Living Hypercholesterolemic Subjects [PhD Thesis]. Department of Clinical Nutrition, Faculty of Medicine, University of Kuopio, 1995.
    1. Sarkkinen ES, Agren JJ, Ahola I, Ovaskainen ML, Uusitupa MI. Fatty acid composition of serum cholesterol esters, and erythrocyte and platelet membranes as indicators of long-term adherence to fat-modified diets. American Journal of Clinical Nutrition 1994;59(2):364-70. - PubMed
    1. Sarkkinen ES, Uusitupa MI, Nyyssonen K, Parviainen M, Penttila I, Salonen JT. Effects of two low-fat diets, high and low in polyunsaturated fatty acids, on plasma lipid peroxides and serum vitamin E levels in free-living hypercholesterolaemic men. European Journal of Clinical Nutrition 1993;47(9):623-30. - PubMed
    1. Sarkkinen ES, Uusitupa MI, Pietinen P, Aro A, Ahola I, Penttila I, et al. Long-term effects of three fat-modified diets in hypercholesterolemic subjects. Atherosclerosis 1994;105(1):9-23. - PubMed
Sarkkinen Low Fat 1993 {published and unpublished data}
    1. Makinen E, Uusitupa MI, Pietinen P, Aro A, Penttila I. Long term effects of three fat modified diets on serum lipids in free living hypercholesterolaemic subjects (abstract). European Heart Journal 1991;12:162.
    1. Sarkkinen E. Long-Term Feasibility and Effects of Three Different Fat-Modified Diets in Free-Living Hypercholesterolemic Subjects [PhD Thesis]. Department of Clinical Nutrition, Faculty of Medicine, University of Kuopio, 1995.
    1. Sarkkinen ES, Agren JJ, Ahola I, Ovaskainen ML, Uusitupa MI. Fatty acid composition of serum cholesterol esters, and erythrocyte and platelet membranes as indicators of long-term adherence to fat-modified diets. American Journal of Clinical Nutrition 1994;59(2):364-70. - PubMed
    1. Sarkkinen ES, Uusitupa MI, Nyyssonen K, Parviainen M, Penttila I, Salonen JT. Effects of two low-fat diets, high and low in polyunsaturated fatty acids, on plasma lipid peroxides and serum vitamin E levels in free-living hypercholesterolaemic men. European Journal of Clinical Nutrition 1993;47(9):623-30. - PubMed
    1. Sarkkinen ES, Uusitupa MI, Pietinen P, Aro A, Ahola I, Penttila I, et al. Long-term effects of three fat-modified diets in hypercholesterolemic subjects. Atherosclerosis 1994;105(1):9-23. - PubMed
Simon 1997 {published and unpublished data}
    1. Djuric Z, Heilbrun LK, Reading BA, Boomer A, Valeriote FA, Martino S. Effects of a low fat diet on levels of oxidative damage to DNA in human peripheral nucleated blood cells. Journal of the National Cancer Institute 1991;83(11):766-9. - PubMed
    1. Djuric Z, Martino S, Heilbrun LK, Hart RW. Dietary modulation of oxidative DNA damage. Advances In Experimental Medicine and Biology 1994;354:71-83. - PubMed
    1. Kasim SE, Martino S, Kim P-N, Khilnani S, Boomer A, Depper J, et al. Dietary and anthropometric determinants of plasma lipoproteins during a long-term low-fat diet in healthy women. American Journal of Clinical Nutrition 1993;57:146-53. - PubMed
    1. Simon MS, Heilbrun LK, Boomer A, Kresge C, Depper J, Kim PN, et al. A randomised trial of a low-fat dietary intervention in women at high risk for breast cancer. Nutrition and Cancer 1997;27(2):136-42. - PubMed
Strychar 2009 {published and unpublished data}
    1. Strychar I, Cohn JS, Renier G, Rivard M, Aris-Jilwan N, Beauregard H, et al. Effects of a diet higher in carbohydrate/lower in fat versus lower in carbohydrate/higher in monounsaturated fat on postmeal triglyceride concentrations and other cardiovascular risk factors in type 1 diabetes. Diabetes Care 2009;32(9):1597-9. - PMC - PubMed
Swinburn 2001 {published and unpublished data}
    1. Ley SJ, Metcalf PA, Scragg RKR, Swinburn BA. Long-term effects of a reduced fat diet intervention on cardiovascular disease risk factors in individuals with glucose intolerance. Diabetes Research and Clinical Practice 2004;63:103-12. - PubMed
    1. Swinburn BA, Metcalf PA, Ley SJ. Long-term (5-year) effects of a reduced-fat diet intervention in individuals with glucose intolerance. Diabetes Care 2001;24(4):619-24. - PubMed
    1. Swinburn BA, Woollard GA, Chang EC, Wilson MR. Effects of reduced-fat diets consumed ad libitum on intake of nutrients particularly antioxidant vitamins. Journal of the American Dietetic Association 1999;99(11):1400-5. - PubMed
WHEL 2007 {published data only}
    1. Bardwell WA, Profant J, Casden DR, Dimsdale JE, Ancoli-Israel S, Natarajan L, et al. The relative importance of specific risk factors for insomnia in women treated for early-stage breast cancer. Psycho-Oncology 2008;17(1):9-18. - PMC - PubMed
    1. Bertram LAC, Stefanick ML, Saquib N, Natarajan L, Patterson RE, Bardwell W, et al. Physical activity, additional breast cancer events, and mortality among early-stage breast cancer survivors: findings from the WHEL Study. Cancer Causes & Control 2011;22(3):427-35. - PMC - PubMed
    1. Caan BJ, Flatt SW, Rock CL, Ritenbaugh C, Newman V, Pierce JP, et al, Women's Healthy Eating and Living Group. Low-energy reporting in women at risk for breast cancer recurrence. Cancer Epidemiology, Biomarkers & Prevention 2000;9(10):1091-7. - PubMed
    1. Gold EB, Flatt SW, Pierce JP, Bardwell WA, Hajek RA, Newman VA, et al. Dietary factors and vasomotor symptoms in breast cancer survivors: the WHEL Study. Menopause 2006;13(3):423-33. - PubMed
    1. Gold EB, Pierce JP, Natarajan L, Stefanick ML, Laughlin GA, Caan BJ, et al. Dietary pattern influences breast cancer prognosis in women without hot flashes: the Women's Healthy Eating and Living trial. Journal of Clinical Oncology 2009;27(3):352-9. - PMC - PubMed
WHI 2006 {published data only}
    1. Anderson G, Cummings S, Freedman LS, Furberg C, Henderson M, Johnson SR, et al. Design of the Women's Health Initiative clinical trial and observational study. Controlled Clinical Trials 1998;19(1):61-109. - PubMed
    1. Anderson GL, Manson J, Wallace R, Lund B, Hall D, Davis S, et al. Implementation of the Women's Health Initiative study design. Annals of Epidemiology 2003;13(9 Suppl):S5-17. - PubMed
    1. Assaf AR, Beresford SAA, Risica PM, Aragaki A, Brunner RL, Bowen DJ, et al. Low-fat dietary pattern intervention and health-related quality of life: the Women’s Health Initiative randomized controlled Dietary Modification trial. Journal of the Academy of Nutrition and Dietetics 2016;116(2):259-71. - PMC - PubMed
    1. Beresford SA, Johnson KC, Ritenbaugh C, Lasser NL, Snetselaar LG, Black HR, et al. Low-fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative randomized controlled Dietary Modification trial. JAMA 2006;295(6):643-54. - PubMed
    1. Bowen D, Ehret C, Pedersen M, Snetselaar L, Johnson M, Tinker L, et al. Results of an adjunct dietary intervention program in the Women's Health Initiative. Journal of the American Dietetic Association 2002;102(11):1631-7. - PubMed
WHTFSMP 2003 {published and unpublished data}
    1. Bhargava A, Guthrie J F. Unhealthy eating habits, physical exercise and macronutrient intakes are predictors of anthropometric indicators in the Women's Health trial: feasibility study in minority populations. British Journal of Nutrition 2002;88(6):719-28. - PubMed
    1. Bhargava A. Dietary modifications and lipid accumulation product are associated with systolic and diastolic blood pressures in the Women's Health trial: feasibility study in minority populations. Current Hypertension Reports 2018;20(6):50. - PubMed
    1. Bowen D, Clifford CK, Coates R, Evans M, Feng Z, Fouad M, et al. The Women's Health trial feasibility study in minority populations: design and baseline descriptions. Annals of Epidemiology 1996;6(6):507-19. - PubMed
    1. Coates RJ, Bowen DJ, Kristal AR, Feng Z, Oberman A, Hall WD, et al. The Women's Health trial feasibility study in minority populations: changes in dietary intakes. American Journal of Epidemiology 1999;149(12):1104-12. - PubMed
    1. Hall WD, Feng Z, George VA, Lewis CE, Oberman A, Huber M, et al, WHT:FSMP. Low-fat diet: effect on anthropometrics, blood pressure, glucose and insulin in older women. Ethnicity and Disease 2003;13:337-43. - PubMed
WHT Full‐scale {published and unpublished data}
    1. Kristal AR, White E, Shattuck AL, Curry S, Anderson GL, Fowler A, et al. Long-term maintenance of a low-fat diet: durability of fat-related dietary habits in the Women's Health trial. Journal of the American Dietetic Association 1992;92(5):553-9. - PubMed
    1. Self S, Prentice R, Iverson D, Henderson M, Thompson D, Byar D, et al. Statistical design of the Women's Health trial. Controlled Clinical Trials 1988;9(2):119-36. - PubMed
    1. White E, Shattuck AL, Kristal AR, Urban N, Prentice RL, Henderson MM, et al. Maintenance of a low-fat diet: follow-up of the Women's Health trial. Cancer Epidemiology, Biomarkers and Prevention 1992;1(4):315-23. - PubMed
WHT Vanguard 1991 {published and unpublished data}
    1. Gorbach SL, Morrill-LaBrode A, Woods MN, Dwyer JT, Selles WD, Henderson M, et al. Changes in food patterns during a low-fat dietary intervention in women. Journal of the American Dietetic Association 1990;90(6):802-9. - PubMed
    1. Henderson MM, Kushi LH, Thompson DJ, Gorbach SL, Clifford CK, Insull W, et al. Feasibility of a randomized trial of a low-fat diet for the prevention of breast cancer: dietary compliance in the Women's Health trial Vanguard study. Preventive Medicine 1990;19(2):115-33. - PubMed
    1. Insull W Jr, Henderson MM, Prentice RL, Thompson DJ, Clifford C, Goldman S, et al. Results of a randomized feasibility study of a low-fat diet. Archives of Internal Medicine 1990;150(2):421-7. - PubMed
    1. Prentice RL, Kakar F, Hursting S, Sheppard L, Klein R, Kushi LH. Aspects of the rationale for the Women's Health trial2. Journal of the National Cancer Institute 1988;80(11):802-14. - PubMed
    1. Self S, Prentice R, Iverson D, Henderson M, Thompson D, Byar D, et al. Statistical design of the Women's Health trial. Controlled Clinical Trials 1988;9(2):119-36. - PubMed
WINS 1993 {published and unpublished data}
    1. Chlebowski RT, Blackburn GL, Buzzard IM, Rose DP, Martino S, Khandekar JD, et al. Adherence to a dietary fat intake reduction program in postmenopausal women receiving therapy for early breast cancer. The Women's Intervention Nutrition study. Journal of Clinical Oncology 1993;11(11):2072-80. - PubMed
    1. Chlebowski RT, Blackburn GL, Thomson CA, Nixon DW, Shapiro A, Hoy MK, et al. Dietary fat reduction and breast cancer outcome: interim efficacy results from the Women's Intervention Nutrition study. Journal of the National Cancer Institute 2006;98(24):1767-76. - PubMed
    1. Chlebowski RT, Blackburn GL. Abstract S5-08: Final survival analysis from the randomized Womens Intervention Nutrition Study (WINS) evaluating dietary intervention as adjuvant breast cancer therapy. Cancer Research 2015;75(9 Suppl):S5-08.
    1. Chlebowski RT, Rose D, Blackburn G, Buzzard M, Khandekar J, York R, et al. Feasibility of using dietary fat intake reduction in adjuvant breast cancer management. Proceedings of American Society of Clinical Oncology 1991;86:86.
    1. Hoy MK, Winters BL, Chlebowski RT, Papoutsakis C, Shapiro A, Lubin MP, et al. Implementing a low-fat eating plan in the Women's Intervention Nutrition study. Journal of the American Dietetic Association 2009;109(4):688-96. - PMC - PubMed
Yadav 2016 {published data only}
    1. NCT00852722. Low fat diet and Multiple Sclerosis (MS). clinicaltrials.gov/ct2/show/NCT00852722 (received 27 FEb 2009).
    1. Yadav V, Marracci G, Kim E, Spain R, Cameron M, Overs S, et al. Effects of a low fat plant based diet in multiple sclerosis (MS): results of a 1-year long randomized controlled (RC) study. Neurology 2014;82(10):P6.152.
    1. Yadav V, Marracci G, Kim E, Spain R, Cameron M, Overs S, et al. Low-fat, plant-based diet in multiple sclerosis: a randomized controlled trial. Multiple Sclerosis and Related Disorders 2016;9:80-90. - PubMed

References to studies excluded from this review

Agewall 2001 {published data only}
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Ammerman 2003 {published data only}
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Aquilani 2000 {published data only}
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Arne 2014 {published data only}
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Arntzenius 1985 {published data only}
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Bakx 1997 {published data only}
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Ball 1965 {published data only}
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Barnard 2009 {published data only}
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Barndt 1977 {published data only}
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Baron 1990 {published data only}
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Beckmann 1995 {published data only}
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Bierenbaum 1963 {published data only}
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Bloomgarden 1987 {published data only}
    1. Bloomgarden ZT, Karmally W, Metzger MJ, Brothers M, Nechemias C, Bookman J, et al. Randomized, controlled trial of diabetic patient education: improved knowledge without improved metabolic status. Diabetes Care 1987;10:263-72. - PubMed
Bonnema 1995 {published data only}
    1. Bonnema SJ, Jespersen LT, Marving J, Gregersen G. Supplementation with olive oil rather than fish oil increases small arterial compliance in diabetic patients. Diabetes, Nutrition and Metabolism Clinical and Experimental 1995;8:81-7.
Brehm 2009 {published data only (unpublished sought but not used)}
    1. Brehm BJ, Lattin BL, Summer SS, Boback JA, Gilchrist GM, Jandacek RJ, et al. One-year comparison of a high-monounsaturated fat diet with a high-carbohydrate diet in type 2 diabetes. Diabetes Care 2009;32(2):215-20. - PMC - PubMed
Brensike 1982 {published data only}
    1. Brensike JF, Kelsey SF, Passamani ER, Fisher MR, Richardson JM, Loh IK, et al. National Heart, Lung, and Blood Institute type II Coronary Intervention Study: design, methods, and baseline characteristics. Controlled Clinical Trials 1982;3(2):91-111. - PubMed
Broekmans 2003 {published and unpublished data}
    1. Broekmans WMR, Klopping-Ketelaars IAA, Weststrate JA, Tijburg LBM, Van Poppel G, Vink AA, et al. Decreased carotenoid concentrations due to dietary sucrose polyesters do not affect possible markers of disease risk in humans. Journal of Nutrition 2003;133:720-6. - PubMed
Brown 1984 {published data only}
    1. Brown GD, Whyte L, Gee MI, Crockford PM, Grace M, Oberle K, et al. Effects of two "lipid-lowering" diets on plasma lipid levels of patients with peripheral vascular disease. Journal of the American Dietetic Association 1984;84(5):546-50. - PubMed
Bruce 1994 {published data only}
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Bruno 1983 {published data only}
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Byers 1995 {published data only}
    1. Byers T, Mullis R, Anderson J, Dusenbury L, Gorsky R, Kimber C, et al. The costs and effects of a nutritional education program following work-site cholesterol screening. American Journal of Public Health 1995;85(5):650-5. - PMC - PubMed
Caggiula 1996 {published data only}
    1. Caggiula AW, Watson JE, Kuller LH, Olson MB, Milas NC, Berry M, et al. Cholesterol-lowering intervention program. Effect of the step I diet in community office practices. Archives of Internal Medicine 1996;156(11):1205-13. - PubMed
CARMEN 2000 {published and unpublished data}
    1. Poppitt SD, Keogh GF, Prentice AM, Williams DEM, Sonnemans HMW, Valk EEJ, et al. Long-term effects of ad libitum low-fat, high-carbohydrate diets on body weight and serum lipids in overweight subjects with metabolic syndrome. American Journal of Clinical Nutrition 2002;75:11-20. - PubMed
    1. Raben A, Astrup A, Vasilaras TH, Prentice AM, Zunft H-JF, Formiguera X, et al. The CARMEN study [CARMEN-studiet]. Ugeskrift fur Laeger 2002;164(5):627-31. - PubMed
    1. Saris WHM, Astrup A, Prentice AM, Zunft FJF, Formiguera X. CARMEN Project: European multicentre study on the impact of dietary fat/CHO ratio and simple/complex CHO changes on long term weight control in overweight subjects. International Journal of Obesity 1997;21(Suppl 2):S71.
    1. Saris WHM, Astrup A, Prentice AM, Zunft HJF, Formiguera X, Verboeket-van de Venne WPHG, et al. Randomized controlled trial of changes in dietary carbohydrate/fat ratio and simple vs complex carbohydrates on body weight and blood lipids: the CARMEN study. International Journal of Obesity 2000;24:1310-8. - PubMed
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CCD 2008 {published data only}81151522
    1. Wolever T M, Gibbs A L, Chiasson J L, Connelly P W, Josse R G, Leiter L A, et al. Altering source or amount of dietary carbohydrate has acute and chronic effects on postprandial glucose and triglycerides in type 2 diabetes: canadian trial of Carbohydrates in Diabetes (CCD). Nutrition, metabolism, and cardiovascular diseases : NMCD 2013;23(3):227‐234. - PubMed
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    1. Wolever TMS, Mehling C, Chiasson JL, Josse RG, Leiter LA, Maheux P, et al. Low glycaemic index diet and disposition index in type 2 diabetes (the Canadian trial of Carbohydrates in Diabetes): a randomised controlled trial. Diabetologia 2008;51(9):1607. - PubMed
Clark 1997 {published data only}
    1. Clark M, Ghandour G, Miller NH, Taylor CB, Bandura A, DeBusk RF. Development and evaluation of a computer-based system for dietary management of hyperlipidemia. Journal of the American Dietetic Association 1997;97(2):146-50. - PubMed
Cocinar para su salud 2016 {published data only}
    1. Greenlee H, Gaffney AO, Aycinena AC, Koch P, Contento I, Karmally W, et al. ¡Cocinar Para Su Salud!: Randomized controlled trial of a culturally based dietary intervention among Hispanic breast cancer survivors. Journal of the Academy of Nutrition and Dietetics 2015;115(5):709-723.e3. - PMC - PubMed
Cohen 1991 {published data only}
    1. Cohen MD, D'Amico FJ, Merenstein JH. Weight reduction in obese hypertensive patients. Family Medicine 1991;23(1):25-8. - PubMed
Coppell 2010 {published data only}
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Cox 1996 {published data only}
    1. Cox RH, Gonzales-Vigilar MCRV, Novascone MA, Silva-Barbeau I. Impact of a cancer intervention on diet-related cardiovascular disease risks of white and African-American EFNEP clients. Journal of Nutrition Education 1996;28:209-18.
Croft 1986 {published data only}
    1. Croft PR, Brigg D, Smith S, Harrison CB, Branthwaite A, Collins MF. How useful is weight reduction in the management of hypertension? Journal of the Royal College of General Practitioners 1986;36(291):445-8. - PMC - PubMed
Dalgard 2001 {published data only}
    1. Dalgard C, Thuroe A, Haastrup B, Haghfelt T, Stender S. Saturated fat intake is reduced in patients with ischemic heart disease 1 year after comprehensive counseling but not after brief counseling. Journal of the American Dietetic Association 2001;101(12):1420-9. - PubMed
Da Qing IGT 1997 {published data only}
    1. Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care 1997;20(4):537-44. - PubMed
DAS 1989 {published data only}
    1. Bovbjerg VE, McCann BS, Brief DJ, Follette WC, Retzlaff BM, Dowdy AA, et al. Spouse support and long-term adherence to lipid-lowering diets. American Journal of Epidemiology 1995;141(5):451-60. - PubMed
    1. Knopp RH, Retzlaff B, Walden C, Fish B, Buck B, McCann B. One-year effects of increasingly fat-restricted, carbohydrate-enriched diets on lipoprotein levels in free-living subjects. Proceedings of the Society for Experimental Biology & Medicine 2000;225(3):191-9. - PubMed
    1. Knopp RH, Walden CE, McCann BS, Retzlaff B, Dowdy A, Gey G, et al. Serial changes in lipoprotein cholesterol in hypercholesterolemic men treated with alternative diets [abstract]. Arteriosclerosis 1989;9:745A.
    1. Knopp RH, Walden CE, Retzlaff BM, McCann BS, Dowdy AA, Albers JJ, et al. Long-term cholesterol-lowering effects of 4 fat-restricted diets in hypercholesterolaemic and combined hyperlipidaemic men: the Dietary Alternatives study. JAMA 1997;278:1509-15. - PubMed
    1. Walden CE, McCann BS, Retzlaff B, Dowdy A, Hanson M, Fish B, et al. Alternative fat-restricted diets for hypercholesterolemia and combined hyperlipidemia: feasibility, design, subject recruitment, and baseline characteristics of the Dietary Alternatives study. Journal of the American College of Nutrition 1991;10(5):429-42. - PubMed
Davey Smith 2005 {published data only}
    1. Davey Smith G, Bracha Y, Svendsen KH, Neaton JD, Haffner SM, Kuller LH, et al. Incidence of type 2 diabetes in the randomized multiple risk factor intervention trial. Annals of Internal Medicine 2005;142(5):313-22. - PubMed
DeBusk 1994 {published data only}
    1. DeBusk RF, Miller NH, Superko HR, Dennis CA, Thomas RJ, Lew HT, et al. A case-management system for coronary risk factor modification after acute myocardial infarction. Annals of Internal Medicine 1994;120(9):721-9. - PubMed
Delahanty 2001 {published data only}
    1. Delahanty LM, Hayden D, Ammerman A, Nathan DM. Medical nutrition therapy for hypercholesterolemia positively affects patient satisfaction and quality of life outcomes. Annals of Behavioral Medicine 2002;24(4):269-78. - PubMed
    1. Delahanty LM, Sonnenberg LM, Hayden D, Nathan DM. Clinical and cost outcomes of medical nutrition therapy for hypercholesterolemia: a controlled trial. Journal of the American Dietetic Association 2001;101(9):1012-23. - PubMed
Delius 1969 {published data only}
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Dengel 1995 {published data only}
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DIRECT 2009 {published data only (unpublished sought but not used)}
    1. Ben-Avraham S, Harman-Boehm I, Schwarzfuchs D, Shai I. Dietary strategies for patients with type 2 diabetes in the era of multi-approaches; review and results from the Dietary Intervention Randomized Controlled Trial (DIRECT). Diabetes Research and Clinical Practice 2009;86(Suppl 1):S41-8. - PubMed
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    1. Durst R, Shpitzen S, Meiner V, Schwarzfuchs D, Stampfer MJ, Schurr D, et al. Insulin receptor substrate 1 gene variation modifies insulin resistance response to various types of dietary strategies: results from the Direct Intervention trial. Journal of the American College of Cardiology 2012;59(13 Suppl):E1664. [DOI: 10.1016/S0735-1097(12)61665-9] - DOI
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Dobs 1991 {published data only}
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DO IT 2006 {published and unpublished data}
    1. Berstad P, Seljeflot I, Veierod MB, Hjerkinn EM, Arnesen H, Pedersen JI, et al. Supplementation with fish oil affects the association between very long-chain n-3 polyunsaturated fatty acids in serum non-esterified fatty acids and soluble vascular cell adhesion molecule-1. Clinical Science 2003;105(1):13-20. - PubMed
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    1. Ellingsen I, Seljeflot I, Arnesen H, Tonstad S. Vitamin C consumption is associated with less progression in carotid intima media thickness in elderly men: a 3-year intervention study. Nutrition Metabolism & Cardiovascular Diseases 2009;19(1):8-14. - PubMed
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    1. Hjerkinn EM, Abdelnoor M, Breivik L, Bergengen L, Ellingsen I, Seljeflot I, et al. Effect of diet or very long chain omega-3 fatty acids on progression of atherosclerosis, evaluated by carotid plaques, intima-media thickness and by pulse wave propagation in elderly men with hypercholesterolaemia. European Journal of Cardiovascular Prevention & Rehabilitation 2006;13(3):325-33. - PubMed
Drummond 1998 {published data only}
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    1. Drummond S, Kirk T. The effect of different types of dietary advice on body composition in a group of Scottish men. Journal of Human Nutrition and Dietetics 1998;11(6):473-85.
Duffield 1982 {published data only}
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Eckard 2013 {published data only}
    1. Eckard C, Cole R, Lockwood J, Torres DM, Williams CD, Shaw JC, et al. Prospective histopathologic evaluation of lifestyle modification in nonalcoholic fatty liver disease: a randomized trial. Therapeutic Advances in Gastroenterology 2013;6:249-59. - PMC - PubMed
Elder 2000 {published data only}
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Entwistle 2018 {published data only}
    1. Entwistle T, Miura K, Keevil BG, et al. Mediterranean and low-fat diets reduce cardiovascular disease after both heart and lung transplantation: results from a randomised trial with 12 month follow up. Nutrition Journal 2018;17:22. [DOI: 10.1186/s12937-018-0337-y] - DOI - PMC - PubMed
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Esposito 2004 {published data only}
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Esposito 2014 {published data only}
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EUROACTION 2008 {published data only}
    1. Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, et al. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet 2008;371(9629):1999-2012. - PubMed
FARIS 1997 {published data only}
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Fasting HGS 1997 {published data only}
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Ferrara 2000 {published data only}
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Finnish Diabetes 2000 {published data only}
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Fleming 2002 {published data only}
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Foster 2003 {published data only}
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Gaullier 2007 {published data only}
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German Fat Reduced {published and unpublished data}
    1. Seppelt B, Weststrate JA, Reinert A, Johnson D, Luder W, Zunft HJ. Long-term effects of nutrition with fat-reduced foods on energy consumption and body weight [Langzeiteffekte einer ernahrung mit fettreduzierten lebensmitteln auf die energieaufnahme und das korpergewicht]. Zeitschrift fur Ernahrungswissenschaft 1996;35(4):369-77. - PubMed
Glatzel 1966 {published data only}
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Goodpaster 1999 {published data only}
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Gower 2012 {published data only}
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Greenlee 2016 {published data only}
    1. NCT01414062. Cook for your life! [Cocinar para su salud!]. clinicaltrials.gov/ct2/show/NCT01414062 (first received 11 August 2011).
Gregg 2013 {published data only}
    1. Gregg EWK. An intensive lifestyle intervention increased remission from type 2 diabetes in overweight adults. Annals of Internal Medicine 2013;158:4. - PubMed
Gudlaugsson 2013 {published data only}
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Guelinckx 2010 {published data only}
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Guldbrand 2012 {published data only}
    1. Guldbrand H, Dizdar B, Bunjaku B, Lindstrom T, Bachrach-Lindstrom M, Fredrikson M, et al. In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss. Diabetologia 2012;55:2118-27. - PMC - PubMed
    1. Guldbrand H, Lindström T, Dizdar B, Bunjaku B, Östgren CJ, Nystrom FH, et al. Randomization to a low-carbohydrate diet advice improves health related quality of life compared with a low-fat diet at similar weight-loss in Type 2 diabetes mellitus. Diabetes Research and Clinical Practice 2014;106(2):221‐7. - PubMed
    1. Jonasson L, Guldbrand H, Lundberg AK, Nystrom FH. Advice to follow a low-carbohydrate diet has a favourable impact on low-grade inflammation in type 2 diabetes compared with advice to follow a low-fat diet. Annals of Medicine 2014;46(3):182‐7. - PMC - PubMed
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Haynes 1984 {published data only}
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Hellenius 1993 {published and unpublished data}
    1. Hellenius ML, Brismar KE, Berglund BH, De FU. Effects on glucose tolerance, insulin secretion, insulin-like growth factor 1 and its binding protein, IGFBP-1, in a randomized controlled diet and exercise study in healthy, middle-aged men. Journal of Internal Medicine 1995;238(2):121-30. - PubMed
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Hildreth 1951 {published data only}
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HIPERCOL 2018 {published data only}
    1. RBR-3ys6h4. Effects of HIPERCOL program on patients with heterozygous familial hypercholesterolemia quality of life [Effect of a nutritional education program on patients with genetic high cholesterol quality of life]. www.ensaiosclinicos.gov.br/rg/RBR-3ys6h4/ (received 9 April 2018).
Hutchison 1983 {published data only}
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Hyman 1998 {published and unpublished data}
    1. Hyman DJ, Ho KSI, Dunn K, Simons-Morton D. Dietary intervention for cholesterol reduction in public clinic patients. American Journal of Preventive Medicine 1998;15:139-45. - PubMed
IMPACT 1995A {published data only}
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Iso 1991 {published data only}
    1. Iso H, Konishi M, Terao A, Kiyama M, Tanigaki M, Baba M, et al. A community-based education program for serum cholesterol reduction in urban hypercholesterolemic persons - comparison of intensive and usual education groups. Nippon Koshu Eisei Zasshi 1991;38(9):751-61. - PubMed
Ives 1993 {published data only}
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Jalkanen 1991 {published data only}
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Janus 2012 {published data only}
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Jonasson 2014 {published data only}
    1. Jonasson L, Guldbrand H, Lundberg AK, Nystrom FH. Advice to follow a low-carbohydrate diet has a favourable impact on low-grade inflammation in type 2 diabetes compared with advice to follow a low-fat diet. Annals of Medicine 2014;46:182-7. - PMC - PubMed
Juanola‐Falgarona 2014 {published data only}
    1. Juanola-Falgarona M, Salas-Salvado J, Ibarrola-Jurado N, Rabassa-Soler A, Bullo M. Effect of dietary glycemic index and glycemic load on body weight and cardiovascular risk factors: the GLYNDIET Study. In: Obesity Facts. 20th European Congress on Obesity, ECO 2013; Liverpool, United Kingdom. Vol. 6. 2013:111.
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Jula 1990 {published data only}
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Karvetti 1992 {published data only}
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Kastarinen 2002 {published data only}
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Kattelmann 2010 {published data only}
    1. Kattelmann KK, Conti K, Ren C, Kattelmann KK, Conti K, Ren C. The Medicine Wheel nutrition intervention: a diabetes education study with the Cheyenne River Sioux Tribe. Journal of the American Dietetic Association 2010;110:S44-51. - PubMed
Katzel 1995 {published data only}
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Klemsdal 2010 {published data only}
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Korhonen 2003 {published data only}
    1. Korhonen M, Kastarinen M, Uusitupa M, Puska P, Nissinen A. The effect of intensified diet counseling on the diet of hypertensive subjects in primary health care: a 2-year open randomized controlled trial of lifestyle intervention against hypertension in eastern Finland. Preventive Medicine 2003;36(1):8-16. - PubMed
Kristal 1997 {published data only}
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Kromhout 1987 {published data only}
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Kummel 2008 {published data only}
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Laitinen 1993 {published data only}
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Laitinen 1994 {published data only}
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Larsen 2011 {published data only}
    1. Larsen RN, Mann NJ, Maclean E, Shaw JE, Larsen RN, Mann NJ, et al. The effect of high-protein, low-carbohydrate diets in the treatment of type 2 diabetes: a 12 month randomised controlled trial. Diabetologia 2011;54:731-40. - PubMed
Leduc 1994 {published data only}
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Leibbrandt 2010 {published data only}
    1. Leibbrandt AJ, Kiefte-de Jong JC, Hogenelst MHE, Snoek FJ, Weijs PJM. Effects of the PRo-active Interdisciplinary Self-MAnagement (PRISMA, Dutch DESMOND) program on dietary intake in type 2 diabetes outpatients: a pilot study. Clinical Nutrition 2010;29:199-205. - PubMed
Lewis 1985 {published data only}
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LIILAC 2015 {published data only}
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Lyon Diet Heart 1994 {published data only}
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Medi‐RIVAGE 2004 {published and unpublished data}
    1. Borel P, Moussa M, Reboul E, Lyan B, Defoort C, Vincent-Baudry S, et al. Human fasting plasma concentrations of vitamin E and carotenoids, and their association with genetic variants in apo C-III, cholesteryl ester transfer protein, hepatic lipase, intestinal fatty acid binding protein and microsomal triacylglycerol transfer protein. British Journal of Nutrition 2009;101(5):680-7. - PubMed
    1. Borel P, Moussa M, Reboul E, Lyan B, Defoort C, Vincent-Baudry S, et al. Human plasma levels of vitamin E and carotenoids are associated with genetic polymorphisms in genes involved in lipid metabolism. Journal of Nutrition 2007;137(12):2653-9. - PubMed
    1. Gastaldi M, Diziere S, Defoort C, Portugal H, Lairon D, Darmon M, et al. Sex-specific association of fatty acid binding protein 2 and microsomal triacylglycerol transfer protein variants with response to dietary lipid changes in the 3-mo Medi-RIVAGE primary intervention study. American Journal of Clinical Nutrition 2007;86(6):1633-41. - PubMed
    1. Vincent S, Gerber M, Bernard MC, Defoort C, Loundou A, Portugal H, et al. The Medi-RIVAGE study (Mediterranean Diet, Cardiovascular Risks and Gene Polymorphisms): rationale, recruitment, design, dietary intervention and baseline characteristics of participants. Public Health Nutrition 2004;7(4):531-42. - PubMed
    1. Vincent-Baudry S, Defoort C, Gerber M, Bernard MC, Verger P, Helal O, et al. The Medi-RIVAGE study: reduction of cardiovascular disease risk factors after a 3-mo intervention with a Mediterranean-type diet or a low-fat diet. American Journal of Clinical Nutrition 2005;82(5):964-71. - PubMed
Merrill 2011 {published data only}
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Michalsen 2006 {published and unpublished data}
    1. Michalsen A, Lehmann N, Pithan C, Knoblauch NT, Moebus S, Kannenberg F, et al. Mediterranean diet has no effect on markers of inflammation and metabolic risk factors in patients with coronary artery disease. European Journal of Clinical Nutrition 2006;60(4):478-85. - PubMed
Millar 1973 {published data only}
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Milne 1994 {published data only}
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Minnesota HHP 1990 {published data only}
    1. Murray DM, Kurth C, Mullis R, Jeffery RW. Cholesterol reduction through low-intensity interventions: results from the Minnesota Heart Health Program. Preventive Medicine 1990;19(2):181-9. - PubMed
MUFObes low fat 2007 {published and unpublished data}
    1. Due A, Larsen TM, Hermansen K, Stender S, Holst JJ, Toubro S, et al. Comparison of the effects on insulin resistance and glucose tolerance of 6-mo high-monounsaturated-fat, low-fat, and control diets. American Journal of Clinical Nutrition 2008;87(4):855-62. - PubMed
    1. Due A, Larsen TM, Mu H, Hermansen K, Stender S, Astrup A. Comparison of 3 ad libitum diets for weight-loss maintenance, risk of cardiovascular disease, and diabetes: a 6-mo randomized, controlled trial. American Journal of Clinical Nutrition 2008;88(5):1232-41. - PubMed
    1. Rasmussen LG, Larsen TM, Mortensen PK, Due A, Astrup A, Rasmussen Lone G, et al. Effect on 24-h energy expenditure of a moderate-fat diet high in monounsaturated fatty acids compared with that of a low-fat, carbohydrate-rich diet: a 6-mo controlled dietary intervention trial. American Journal of Clinical Nutrition 2007;85(4):1014-22. - PubMed
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MUFObes low vs mod 2007 {published and unpublished data}
    1. Due A, Larsen TM, Hermansen K, Stender S, Holst JJ, Toubro S, et al. Comparison of the effects on insulin resistance and glucose tolerance of 6-mo high-monounsaturated-fat, low-fat, and control diets. American Journal of Clinical Nutrition 2008;87(4):855-62. - PubMed
    1. Due A, Larsen TM, Mu H, Hermansen K, Stender S, Astrup A, et al. Comparison of 3 ad libitum diets for weight-loss maintenance, risk of cardiovascular disease, and diabetes: a 6-mo randomized, controlled trial. American Journal of Clinical Nutrition 2008;88(5):1232-41. - PubMed
    1. Rasmussen LG, Larsen TM, Mortensen PK, Due A, Astrup A, Rasmussen Lone G, et al. Effect on 24-h energy expenditure of a moderate-fat diet high in monounsaturated fatty acids compared with that of a low-fat, carbohydrate-rich diet: a 6-mo controlled dietary intervention trial. American Journal of Clinical Nutrition 2007;85(4):1014-22. - PubMed
    1. Sloth B, Due A, Larsen TM, Holst JJ, Heding A, Astrup A, et al. The effect of a high-MUFA, low-glycaemic index diet and a low-fat diet on appetite and glucose metabolism during a 6-month weight maintenance period. British Journal of Nutrition 2009;101(12):1846-58. - PubMed
Mujeres Felices 2003 {published data only}
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Murillo‐Ortiz 2017 {published data only}
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Naglak 2000 {published data only (unpublished sought but not used)}
    1. Naglak MC, Mitchell DC, Shannon BM, Pearson TA, Harkness WL, Kris-Etherton PM. Nutrient adequacy of diets of adults with hypercholesterolemia after a cholesterol-lowering intervention: long term assessment. Journal of the American Dietetic Association 2000;100(11):1385-91. - PubMed
NCT02353416 {published data only}
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NCT02368405 {published data only}
    1. NCT02368405. Nutrition education for cardiovascular disease prevention in spinal cord injury. clinicaltrials.gov/ct2/show/NCT02368405 (received 23 Feb 2015).
NCT02396264 {published data only}
    1. NCT02396264. Mediterranean diet as treatment for normal weight women with PCOS. clinicaltrials.gov/ct2/show/NCT02396264 (received 24 March 2015).
Neil 1995 {published data only}
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Next Step 1995 {published and unpublished data}
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Norway Veg Oil 1968 {published data only}
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Novotny 2012 {published data only}
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Nutri‐EPA 2017 {published data only}
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Nutrition Ed Study 1980 {published data only (unpublished sought but not used)}
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Oldroyd 2001 {published data only}
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Orazio 2011 {published data only}
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ORIGIN 2008 {published data only}
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Ornish 1990 {published data only}
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Oslo Study 1980 {published data only}
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Otago Weight Loss 2005 {published and unpublished data}
    1. McAuley KA, Hopkins CM, Smith KJ, McLay RT, Williams SM, Taylor RW, et al. Comparison of a high-fat and high-protein diets with a high-carbohydrate diet in insulin-resistant obese women. Diabetologia 2005;48:8-16. - PubMed
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Pascale 1995 {published data only}
    1. Pascale RW, Wing RR, Butler BA, Mullen M, Bononi P. Effects of a behavioral weight loss program stressing calorie restriction versus calorie plus fat restriction in obese individuals with NIDDM or a family history of diabetes. Diabetes Care 1995;18(9):1241-8. - PubMed
Paz‐Tal 2013 {published data only}
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PEP 2001 {published data only}
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PHYLLIS 1993 {published data only}
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Portfolio 5 {published data only}
    1. Jenkins DJ, Jones PJ, Frohlich J, Lamarche B, Ireland C, Nishi SK, et al. The effect of a dietary portfolio compared to a DASH-type diet on blood pressure. Nutrition, Metabolism, and Cardiovascular Diseases 2015;25(12):1132-9. - PubMed
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PREDIMED 2006 {published data only (unpublished sought but not used)}
    1. Buil-Cosiales P, Irimia P, Ros E, Riverol M, Gilabert R, Martinez-Vila E, et al. Dietary fibre intake is inversely associated with carotid intima-media thickness: a cross-sectional assessment in the PREDIMED study. European Journal of Clinical Nutrition 2009;63(10):1213-9. - PubMed
    1. Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ruiz-Gutierrez V, Covas MI, et al. Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial. Annals of Internal Medicine 2006;145(1):1-11. - PubMed
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PREMIER 2003 {published and unpublished data}
    1. Appel LJ, Champagne CM, Harsha DW, Cooper LS, Obarzanek E, Elmer PJ, et al. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. JAMA 2003;289(16):2083-93. - PubMed
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    1. Ledikwe JH, Rolls BJ, Smiciklas-Wright H, Mitchell DC, Ard JD, Champagne C, et al. Reductions in dietary energy density are associated with weight loss in overweight and obese participants in the PREMIER trial. American Journal of Clinical Nutrition 2007;85(5):1212-21. - PubMed
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Pritchard 2002 {published data only}
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Reid 2002 {published data only}
    1. Reid R, Fodor G, Lydon-Hassen K, D'Angelo MS, McCrea J, Bowlby M, et al. Dietary counselling for dyslipidemia in primary care: results of a randomized trial. Canadian Journal of Dietetic Practice & Research 2002;63(4):169-75. - PubMed
Roderick 1997 {published and unpublished data}
    1. Roderick P, Ruddock V, Hunt P, Miller G. A randomized trial to evaluate the effectiveness of dietary advice by practice nurses in lowering diet-related coronary heart disease risk. British Journal of General Practice 1997;47(414):7-12. - PMC - PubMed
Roman CHD prev 1986 {published data only}
    1. Anon. The Roman Coronary Disease Prevention Project: effectiveness of intervention and reduction of mortality over a 10-year period [II Progetto Romano di Prevenzione della Cardiopatia Coronarica: efficacia dell'intervento e riduzione della mortalita in 10 anni]. Giornale Italiano di Cardiologia 1986;16(3):196-202. - PubMed
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Rose 1987 {published data only}
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Rusu 2013 {published data only}
    1. Rusu E, Jinga M, Enache G, Rusu F, Dragomir AD, Ancuta I, et al. Effects of lifestyle changes including specific dietary intervention and physical activity in the management of patients with chronic hepatitis C - a randomized trial. Nutrition Journal 2013;12:119. - PMC - PubMed
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Sacks 2009 {published and unpublished data}
    1. Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, et al. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. New England Journal of Medicine 2009;360(9):859-73. - PMC - PubMed
Salas‐Salvado 2014 {published data only}
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Schectman 1996 {published data only}
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Schlierf 1995 {published data only}
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Singh 1991 {published data only}
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Singh 1992 {published data only}
    1. Singh RB, Niaz MA, Agarwal P, Begom R, Rastogi SS. Effect of antioxidant-rich foods on plasma ascorbic acid, cardiac enzyme, and lipid peroxide levels in patients hospitalized with acute myocardial infarction. Journal of the American Dietetic Association 1995;95(7):775-80. - PubMed
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Siqueira‐Catania 2010 {published data only}
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SLIM 2008 {published data only}
    1. Roumen C, Corpeleijn E, Feskens EJ, Mensink M, Saris WH, Blaak EE, et al. Impact of 3-year lifestyle intervention on postprandial glucose metabolism: the SLIM study. Diabetic Medicine 2008;25(5):597-605. - PubMed
Sondergaard 2003 {published and unpublished data}
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Sopotsinskaia 1992 {published data only}
    1. Sopotsinskaia EB, Balitskii KP, Tarutinov VI, Zhukova VM, Semenchuk DD, Kozlovskaia SG, et al. Experience with the use of a low-calorie diet in breast cancer patients to prevent metastasis [Opyt primeneniia nizkokaloriinoi diety u bol'nykh rakom molochnoi zhelezy s tsel'iu profilaktiki metastazi]. Voprosy Onkologii 1992;38(5):592-9. - PubMed
Stanford Weight {published and unpublished data}
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Steinbach 1996 {published data only}
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Stevens 2002 {published and unpublished data}
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Stevenson 1988 {published data only}
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Sweeney 2004 {published data only}
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THIS DIET 2008 {published data only}
    1. Tuttle KR, Shuler LA, Packard DP, Milton JE, Daratha KB, Bibus DM, et al. Comparison of low-fat versus Mediterranean-style dietary intervention after first myocardial infarction (from The Heart Institute of Spokane Diet Intervention and Evaluation Trial). American Journal of Cardiology 2008;101(11):1523-30. - PubMed
TOHP I 1992 {published data only}
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References to studies awaiting assessment

Casas‐Agustench 2013 {published data only}
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ICFAMED {published data only}
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MEDINA {published data only}
    1. ACTRN12615001010583. MEDINA: Mediterranean dietary intervention study in NonAlcoholic Fatty Liver Disease (NAFLD) patients [The effects of a Mediterranean Dietary Intervention on insulin resistance and hepatic steatosis in patients with NonAlcoholic Fatty Liver Disease (NAFLD).]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369214 (received 28 August 2015).
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References to ongoing studies

NCT02481466 due 2020 {published data only}
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NCT02938832 due 2023 {published data only}
    1. NCT02938832. Does the advice to eat a Mediterranean diet with low carbohydrate intake, compared with a low-fat diet, reduce diabetes and cardiovascular disease? clinicaltrials.gov/ct2/show/NCT02938832 (first received 19 October 2016).
NCT03068078 due 2020 {published data only}
    1. NCT03068078. A reduced-carbohydrate diet high in monounsaturated fats in type 2 diabetes (ReDuCtion). clinicaltrials.gov/ct2/show/NCT03068078 (received 1 March 2017).

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