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Meta-Analysis
. 2012 May 16;2012(5):CD002137.
doi: 10.1002/14651858.CD002137.pub3.

Reduced or modified dietary fat for preventing cardiovascular disease

Affiliations
Meta-Analysis

Reduced or modified dietary fat for preventing cardiovascular disease

Lee Hooper et al. Cochrane Database Syst Rev. .

Abstract

Background: Reduction and modification of dietary fats have differing effects on cardiovascular risk factors (such as serum cholesterol), but their effects on important health outcomes are less clear.

Objectives: To assess the effect of reduction and/or modification of dietary fats on mortality, cardiovascular mortality, cardiovascular morbidity and individual outcomes including myocardial infarction, stroke and cancer diagnoses in randomised clinical trials of at least 6 months duration.

Search methods: For this review update, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE, were searched through to June 2010. References of Included studies and reviews were also checked.

Selection criteria: Trials fulfilled the following criteria: 1) randomised with appropriate control group, 2) intention to reduce or modify fat or cholesterol intake (excluding exclusively omega-3 fat interventions), 3) not multi factorial, 4) adult humans with or without cardiovascular disease, 5) intervention at least six months, 6) mortality or cardiovascular morbidity data available.

Data collection and analysis: Participant numbers experiencing health outcomes in each arm were extracted independently in duplicate and random effects meta-analyses, meta-regression, sub-grouping, sensitivity analyses and funnel plots were performed.

Main results: This updated review suggested that reducing saturated fat by reducing and/or modifying dietary fat reduced the risk of cardiovascular events by 14% (RR 0.86, 95% CI 0.77 to 0.96, 24 comparisons, 65,508 participants of whom 7% had a cardiovascular event, I(2) 50%). Subgrouping suggested that this reduction in cardiovascular events was seen in studies of fat modification (not reduction - which related directly to the degree of effect on serum total and LDL cholesterol and triglycerides), of at least two years duration and in studies of men (not of women). There were no clear effects of dietary fat changes on total mortality (RR 0.98, 95% CI 0.93 to 1.04, 71,790 participants) or cardiovascular mortality (RR 0.94, 95% CI 0.85 to 1.04, 65,978 participants). This did not alter with sub-grouping or sensitivity analysis.Few studies compared reduced with modified fat diets, so direct comparison was not possible.

Authors' conclusions: The findings are suggestive of a small but potentially important reduction in cardiovascular risk on modification of dietary fat, but not reduction of total fat, in longer trials. Lifestyle advice to all those at risk of cardiovascular disease and to lower risk population groups, should continue to include permanent reduction of dietary saturated fat and partial replacement by unsaturates. The ideal type of unsaturated fat is unclear.

PubMed Disclaimer

Conflict of interest statement

LH was employed as a dietitian working in the area of cardiac rehabilitation for much of the duration of the first version of this review. RLT and CDS are also dietitians.

Figures

1
1
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
2
2
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
3
3
Funnel plot of comparison: fat modification or reduction vs usual diet ‐ total mortality.
4
4
Funnel plot of comparison: fat modification or reduction vs usual diet ‐ combined cardiovascular events.
5
5
Summary of findings, for reduced or modified fat diets vs usual diet (primary outcomes).
6
6
Summary of findings, reduced fat vs modified fat diets, cardiovascular events.
7
7
Summary of findings, reduced or modified dietary fat vs usual diet, important secondary outcomes (myocardial infarction, stroke, cancer diagnosis)
1.1
1.1. Analysis
Comparison 1 fat modification or reduction vs usual diet ‐ primary outcomes, Outcome 1 Total mortality.
1.2
1.2. Analysis
Comparison 1 fat modification or reduction vs usual diet ‐ primary outcomes, Outcome 2 Cardiovascular mortality.
1.3
1.3. Analysis
Comparison 1 fat modification or reduction vs usual diet ‐ primary outcomes, Outcome 3 Combined cardiovascular events.
2.1
2.1. Analysis
Comparison 2 fat modification or reduction vs usual diet ‐ secondary outcomes, Outcome 1 Myocardial infarctions.
2.2
2.2. Analysis
Comparison 2 fat modification or reduction vs usual diet ‐ secondary outcomes, Outcome 2 Stroke.
2.3
2.3. Analysis
Comparison 2 fat modification or reduction vs usual diet ‐ secondary outcomes, Outcome 3 Cancer deaths.
2.4
2.4. Analysis
Comparison 2 fat modification or reduction vs usual diet ‐ secondary outcomes, Outcome 4 Cancer diagnoses.
2.5
2.5. Analysis
Comparison 2 fat modification or reduction vs usual diet ‐ secondary outcomes, Outcome 5 Diabetes diagnoses.
2.6
2.6. Analysis
Comparison 2 fat modification or reduction vs usual diet ‐ secondary outcomes, Outcome 6 Non‐fatal MI.
3.1
3.1. Analysis
Comparison 3 fat modification or reduction vs usual diet ‐ tertiary outcomes, Outcome 1 Weight, kg.
3.2
3.2. Analysis
Comparison 3 fat modification or reduction vs usual diet ‐ tertiary outcomes, Outcome 2 BMI, kg/m2.
3.3
3.3. Analysis
Comparison 3 fat modification or reduction vs usual diet ‐ tertiary outcomes, Outcome 3 LDL cholesterol, mmol/L.
3.4
3.4. Analysis
Comparison 3 fat modification or reduction vs usual diet ‐ tertiary outcomes, Outcome 4 HDL cholesterol, mmol/Lkg.
3.5
3.5. Analysis
Comparison 3 fat modification or reduction vs usual diet ‐ tertiary outcomes, Outcome 5 Total cholesterol, mmol/L.
3.6
3.6. Analysis
Comparison 3 fat modification or reduction vs usual diet ‐ tertiary outcomes, Outcome 6 Triglycerides, mmol/L.
3.7
3.7. Analysis
Comparison 3 fat modification or reduction vs usual diet ‐ tertiary outcomes, Outcome 7 Systolic Blood Pressure, mmHg.
3.8
3.8. Analysis
Comparison 3 fat modification or reduction vs usual diet ‐ tertiary outcomes, Outcome 8 Diastolic Blood Pressure, mmHg.
4.3
4.3. Analysis
Comparison 4 fat reduction vs fat modification ‐ primary outcomes, Outcome 3 Combined cardiovascular events.
5.1
5.1. Analysis
Comparison 5 fat reduction vs fat modification ‐ secondary outcomes, Outcome 1 Myocardial infarction.
5.2
5.2. Analysis
Comparison 5 fat reduction vs fat modification ‐ secondary outcomes, Outcome 2 Stroke.
5.4
5.4. Analysis
Comparison 5 fat reduction vs fat modification ‐ secondary outcomes, Outcome 4 Cancer diagnoses.
5.6
5.6. Analysis
Comparison 5 fat reduction vs fat modification ‐ secondary outcomes, Outcome 6 Non‐fatal MI.
6.1
6.1. Analysis
Comparison 6 fat reduction vs fat modification ‐ tertiary outcomes, Outcome 1 Weight, kg.
6.2
6.2. Analysis
Comparison 6 fat reduction vs fat modification ‐ tertiary outcomes, Outcome 2 BMI, kg/m2.
6.3
6.3. Analysis
Comparison 6 fat reduction vs fat modification ‐ tertiary outcomes, Outcome 3 LDL cholesterol, mmol/L.
6.4
6.4. Analysis
Comparison 6 fat reduction vs fat modification ‐ tertiary outcomes, Outcome 4 HDL cholesterol, mmol/Lkg.
6.5
6.5. Analysis
Comparison 6 fat reduction vs fat modification ‐ tertiary outcomes, Outcome 5 Total cholesterol, mmol/L.
6.6
6.6. Analysis
Comparison 6 fat reduction vs fat modification ‐ tertiary outcomes, Outcome 6 Triglycerides, mmol/L.
6.7
6.7. Analysis
Comparison 6 fat reduction vs fat modification ‐ tertiary outcomes, Outcome 7 Systolic Blood Pressure, mmHg.
6.8
6.8. Analysis
Comparison 6 fat reduction vs fat modification ‐ tertiary outcomes, Outcome 8 Diastolic Blood Pressure, mmHg.
6.9
6.9. Analysis
Comparison 6 fat reduction vs fat modification ‐ tertiary outcomes, Outcome 9 Dropouts.

Update of

Comment in

References

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    1. Baker BM, Frantz ID Jr, Keys A, Kinsell LW, Page IH, Stamler J, et al. The National Diet‐Heart Study: An initial report. JAMA 1963;185:105‐6. - PubMed
    1. Brown HB. The National Diet Heart Study ‐ implications for dietitians and nutritionists. Journal of the American Dietetic Association 1968;52:279‐87. - PubMed
    1. Page IH, Brown HB. Some observations on the National Diet‐Heart Study. Circulation 1968;37:313‐5. - PubMed
NDHS Open 1st mod 1968 {published data only}
    1. The National Diet‐Heart Study. Nutrition Reviews 1968;26(5):133‐6. - PubMed
    1. The national diet‐heart study final report. Circulation 1968;37(II):1‐428. - PubMed
    1. Baker BM, Frantz ID Jr, Keys A, Kinsell LW, Page IH, Stamler J, et al. The National Diet‐Heart Study: An initial report. JAMA 1963;185:105‐6. - PubMed
    1. Brown HB. The National Diet Heart Study ‐ implications for dietitians and nutritionists. Journal of the American Dietetic Association 1968;52:279‐87. - PubMed
    1. Page IH, Brown HB. Some observations on the National Diet‐Heart Study. Circulation 1968;37:313‐5. - PubMed
NDHS Open 2nd L&M 1968 {published data only}
    1. The National Diet‐Heart Study. Nutrition Reviews 1968;26(5):133‐6. - PubMed
    1. The national diet‐heart study final report. Circulation 1968;37(II):1‐428. - PubMed
    1. Baker BM, Frantz ID Jr, Keys A, Kinsell LW, Page IH, Stamler J, et al. The National Diet‐Heart Study: An initial report. JAMA 1963;185:105‐6. - PubMed
    1. Brown HB. The National Diet Heart Study ‐ implications for dietitians and nutritionists. Journal of the American Dietetic Association 1968;52:279‐87. - PubMed
    1. Page IH, Brown HB. Some observations on the National Diet‐Heart Study. Circulation 1968;37:313‐5. - PubMed
NDHS Open 2nd Mod 1968 {published data only}
    1. The National Diet‐Heart Study. Nutrition Reviews 1968;26(5):133‐6. - PubMed
    1. The national diet‐heart study final report. Circulation 1968;37(II):1‐428. - PubMed
    1. Baker BM, Frantz ID Jr, Keys A, Kinsell LW, Page IH, Stamler J, et al. The National Diet‐Heart Study: An initial report. JAMA 1963;185:105‐6. - PubMed
    1. Brown HB. The National Diet Heart Study ‐ implications for dietitians and nutritionists. Journal of the American Dietetic Association 1968;52:279‐87. - PubMed
    1. Page IH, Brown HB. Some observations on the National Diet‐Heart Study. Circulation 1968;37:313‐5. - PubMed
Nutrition & Breast Health {published and unpublished data}
    1. Djuric Z, Poore KM, Depper JB, Uhley VE, Lababidi S, Covington C, et al. Methods to increase fruit and vegetable intake with and without a decrease in fat intake: compliance and effects on body weight in the Nutrition and Breast Health Study. Nutrition and Cancer 2002;43(2):141‐51. - PubMed
Ole Study 2002 {published and unpublished data}
    1. Bray GA, Lovejoy JC, Most‐Windhauser M, Smith SR, Volaufova J, Denkins Y, et al. A 9‐mo randomized clinical trial comparing fat‐substituted and fat‐reduced diets in healthy obese men: the Ole Study. American Journal of Clinical Nutrition 2002;76:928‐34. - PubMed
    1. Lovejoy JC, Bray GA, Lefevre M, Smith SR, Most MM, Denkins YM, et al. Consumption of a controlled low‐fat diet containing olestra for 9 months improves health risk factors in conjunction with weight loss in obese men: the Ole Study. International Journal of Obesity 2003;27:1242‐9. - PubMed
Oslo Diet‐Heart 1966 {published and unpublished data}
    1. Leren P. Prevention of coronary heart disease, some results from the Oslo secondary and primary intervention studies. Journal of the American College of Nutrition 1989;8:407‐10. - PubMed
    1. Leren P. The Oslo diet‐heart study. Eleven year report. Circulation 1970;42:935‐42. - PubMed
    1. Leren P. The effect of plasma cholesterol lowering diet in male survivors of myocardial infarction. A controlled clinical trial. Acta Medica Scandinavia. Supplementum 1966;466:1‐92. - PubMed
    1. Leren P. The effect of plasma‐cholesterol‐lowering diet in male survivors of myocardial infarction. A controlled clinical trial. Bulletin of the New York Academy of Medicine 1968;44:1012‐20. - PMC - PubMed
    1. Leren P. The effect of a cholesterol lowering diet in male survivors of myocardial infarction. (A controlled clinical trial) [Virkningen av cholesterolsenkende diett hos menn som har gjennomgatt hjerteinfarkt. Et kontrollert klinisk fors/ok]. Nordisk Medicin 1967;77(21):658‐61. - PubMed
Oxford Retinopathy 1978 {published and unpublished data}
    1. Coppack SW, Doll HA, Pim B, Hockaday TDR. Intravenous glucose tollerance and mortality in non‐insulin‐dependant diabetes mellitus. Quarterly Journal of Medicine 1990;75:451‐60. - PubMed
    1. Hillson RM, Hockaday TDR, Mann JI, Newton DJ. Hyperinsulinaemia is associated with development of ECG abnormalities in diabetics. Diabetes Research 1984;1:143‐9. - PubMed
    1. Hockaday TD, Hockaday JM, Mann JI, Turner RC. Prospective comparison of modified fat‐high‐carbohydrate with standard low‐carbohydrate dietary advice in the treatment of diabetes: one year follow‐up study. British Journal of Nutrition 1978;39(2):357‐62. - PubMed
    1. Howard‐Williams J, Patel P, Jelfs R, Carter RD, Awdry P, Bron A, et al. Polyunsaturated fatty acids and diabetic retinopathy. British Journal of Ophthalmology 1985;69(1):15‐8. - PMC - PubMed
    1. Lopez‐Espinoza I, Howard WJ, Mann JI, Carter RD, Hockaday TD. Fatty acid composition of platelet phospholipids in non‐insulin‐dependent diabetics randomized for dietary advice. British Journal of Nutrition 1984;52(1):41‐7. - PubMed
Polyp Prevention 1996 {published and unpublished data}
    1. Lanza E, Schatzkin A, Ballard BR, Clifford DC, Paskett E, Hayes D, et al. The polyp prevention trial II: dietary intervention program and participant baseline dietary characteristics. Cancer Epidemiology, Biomarkers and Prevention 1996;5(5):385‐92. - PubMed
    1. Schatzkin A, Lanza E, Freedman LS, Tangrea J, Cooper MR, Marshall JR, et al. The polyp prevention trial I: rationale, design, recruitment, and baseline participant characteristics. Cancer Epidemiology, Biomarkers and Prevention 1996;5(5):375‐83. - PubMed
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
    1. Elmer PJ, Obarzanek E, Vollmer WM, Simons‐Morton D, Stevens VJ, Young DR, et al. Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18‐month results of a randomized trial. Annals of Internal Medicine 2006;144(7):485‐95. - PubMed
    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
    1. Lien LF, Brown AJ, Ard JD, Loria C, Erlinger TP, Feldstein AC, et al. Effects of PREMIER lifestyle modifications on participants with and without the metabolic syndrome. Hypertension 2007;50(4):609‐16. - PubMed
    1. Lin PH, Appel LJ, Funk K, Craddick S, Chen C, Elmer P, et al. The PREMIER intervention helps participants follow the Dietary Approaches to Stop Hypertension dietary pattern and the current Dietary Reference Intakes recommendations. Journal of the American Dietetic Association 2007;107(9):1541‐51. - PubMed
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
Rose 1965 {published data only}
    1. Rose GA, Thomson WB, Williams RT. Corn oil in treatment of ischaemic heart disease. British Medical Journal 1965;1:1531‐3. - PMC - PubMed
Sacks high protein 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
Sacks low protein 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
Sarkkinen Fat Mod 1995 {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 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
    1. Sarkkinen, E. Long‐term feasibility and effects of three different fat‐modified diets in free‐living hypercholesterolemic subjects. Kuopio, Finland: Univ. of Kuopio, 1995.
Sarkkinen Red & Mod 1995 {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 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
    1. Sarkkinen, E. Long‐term feasibility and effects of three different fat‐modified diets in free‐living hypercholesterolemic subjects. Kuopio, Finland: Univ. of Kuopio, 1995.
Sarkkinen Red Fat 1995 {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 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
    1. Sarkkinen, E. Long‐term feasibility and effects of three different fat‐modified diets in free‐living hypercholesterolemic subjects. Kuopio, Finland: Univ. of Kuopio, 1995.
Sarkkinen Red vs Mod1995 {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 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
    1. Sarkkinen, E. Long‐term feasibility and effects of three different fat‐modified diets in free‐living hypercholesterolemic subjects. Kuopio, Finland: Univ. of Kuopio, 1995.
Seppelt 1996 {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 Ernährung mit fettreduzierten Lebensmitteln auf die Energieaufnahme und das Körpergewicht]. Zeitschrift für Ernährungswissenschaft 1996;35(4):369‐77. - 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
Sondergaard 2003 {published and unpublished data}
    1. Sondergaard E, Moller JE, Egstrup K. Effect of dietary intervention and lipid‐lowering treatment on brachial vasoreactivity in patients with ischemic heart disease and hypercholesterolemia. American Heart Journal 2003;145(5):E19. - PubMed
STARS 1992 {published and unpublished data}
    1. Blann AD, Jackson P, Bath PM, Watts GF. von Willebrand factor, a possible indicator of endothelial cell damage, decreases during long‐term compliance with a lipid‐lowering diet. Journal of Internal Medicine 1995;237:557‐61. - PubMed
    1. Watts GF. Nutritional, metabolic, and genetic determinants of the progression of coronary heart disease. STARS Group. Journal of Cardiovascular Pharmacology 1995;25(Suppl 4):S11‐9. - PubMed
    1. Watts GF, Brunt JNH, Coltart DJ, Lewis B. The St. Thomas Atherosclerosis Regression Study (STARS). Atherosclerosis 1992;97:231.
    1. Watts GF, Jackson P, Burke V, Lewis B. Dietary fatty acids and progression of coronary artery disease in men. American Journal of Clinical Nutrition 1996;64:202‐9. - PubMed
    1. Watts GF, Jackson P, Mandalia S, Brunt JN, Lewis ES, Coltart DJ, et al. Nutrient intake and progression of coronary artery disease. American Journal of Cardiology 1994;73(5):328‐32. - PubMed
Strychar 2009 {published and unpublished data}
    1. Strychar I, Cohn JS, Renier G, Rivard M, ris‐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
Sydney Diet‐Heart 1978 {published and unpublished data}
    1. Blacket RB, Leelarthaepin B, McGilchrist C, Palmer AJ, Woodhill JM. The synergistic effect of weight loss and changes in dietary lipids on the serum cholesterol of obese men with hypercholesterolaemia: implications for prevention of coronary heart disease. Australian and New Zealand Journal of Medicine 1979;9:521‐9. - PubMed
    1. Woodhill JM, Palmer AJ, Leelarthaepin B, McGilchrist C, Blacket RB. Low fat, low cholesterol diet in secondary prevention of coronary heart disease. Advances in Experimental Medicine and Biology 1978;109:317‐30. - PubMed
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
Veterans Admin 1969 {published data only}
    1. Dayton S, Hashimoto S, Dixon W, Pearce ML. Composition of lipids in human serum and adipose tissue during prolonged feeding of a diet high in unsaturated fat. Journal of Lipid Research 1966;7:103‐11. - PubMed
    1. Dayton S, Hashimoto S, Pearce ML. Adipose tissue linoleic acid as a criterion of adherence to a modified diet. Journal of Lipid Research 1967;8:508‐10. - PubMed
    1. Dayton S, Hashimoto S, Pearce ML. Influence of a diet high in unsaturated fat upon composition of arterial tissue and atheromata in man. Circulation 1965;32:911‐24. - PubMed
    1. Dayton S, Hashimoto S, Rosenblum D, Pearce M. Vitamin E status of humans during prolonged feeding of unsaturated fats. Journal of Laboratory and Clinical Medicine 1965;65(5):739‐47. - PubMed
    1. Dayton S, Pearce ML. Diet and atherosclerosis. Lancet 1970;1(644):473‐4. - PubMed
WHEL 2007 {published data only}
    1. Bardwell WA, Profant J, Casden DR, Dimsdale JE, ncoli‐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. Caan BJ, Flatt SW, Rock CL, Ritenbaugh C, Newman V, Pierce JP, et al. Low‐energy reporting in women at risk for breast cancer recurrence. Women's Healthy Eating and Living Group. 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
    1. Hernandez‐Valero MA, Thomson CA, Hernandez M, Tran T, Detry MA, Theriault RL, et al. Comparison of baseline dietary intake of Hispanic and matched non‐Hispanic white breast cancer survivors enrolled in the Women's Healthy Eating and Living study. Journal of the American Dietetic Association 2008;108(8):1323‐9. - PMC - PubMed
WHI with CVD 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. Howard BV, Horn L, Hsia J, Manson JE, Stefanick ML, Wassertheil‐Smoller S, et al. Low‐fat dietary pattern and risk of cardiovascular disease: the Women's Health Initiative Randomized Controlled Dietary Modification Trial. JAMA 2006;295(6):655‐66. - PubMed
    1. Rossouw JE, Finnegan LP, Harlan WR, Pinn VW, Clifford C, McGowan JA. The evolution of the Women's Health Initiative: perspectives from the NIH. Journal of the American Medical Women's Association 1995;50(2):50‐5. - PubMed
WHI without CVD 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. 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
    1. Curb JD, McTiernan A, Heckbert SR, Kooperberg C, Stanford J, Nevitt M, et al. Outcomes ascertainment and adjudication methods in the Women's Health Initiative. Annals of Epidemiology 2003;13(9 Suppl):S122‐8. - PubMed
WINS 2006 {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. JNCI Journal of the National Cancer Institute 2006;98(24):1767‐76. - PubMed
    1. Chlebowski RT, Rose DP, Buzzard IM, Blackburn GL, York M, Insull W, et al. Dietary fat reduction in adjuvant breast cancer therapy: current rationale and feasibility issues. Adjuvant. The Cancer Journal 1990;6:357‐63.
    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
    1. Rose DP, Chlebowski RT, Connolly JM, Jones LA, Wynder EL. Effects of tamoxifen adjuvant therapy and a low‐fat diet on serum binding proteins and estradiol bioavailability in postmenopausal breast cancer patients. Cancer Research 1992;52:5386‐90. - PubMed

References to studies excluded from this review

Agewall 2001 {published data only}
    1. Agewall S. Multiple risk intervention trial in high risk hypertensive men: comparison of ultrasound intima‐media thickness and clinical outcome during 6 years of follow‐up. Journal of Internal Medicine 2001;249(4):305‐14. - PubMed
Ammerman 2003 {published data only}
    1. Ammerman AS, Keyserling TC, Atwood JR, Hosking JD, Zayed H, Krasny C. A randomized controlled trial of a public health nurse directed treatment program for rural patients with high blood cholesterol. Preventive Medicine 2003;36(3):340‐51. - PubMed
Anti‐Coronary C 1966 {published data only}
    1. Christakis G, Rinzler SH, Archer M, Maslansky E. Summary of the research activities of the Anti‐Coronary Club. Public Health Report (Washington) 1966;81:64‐70. - PMC - PubMed
    1. Christakis G, Rinzler SH, Archer M, et al. Effect of the Anti‐Coronary Club Program on coronary heart disease risk factor status. JAMA 1969;198:129‐36. - PubMed
    1. Jolliffe N, Baumgarter L, Rinzler SH, Archer M, Stephenson JH, Christakis GJ. The Anti‐Coronary Club: The first four years. New York State Journal of Medicine 1963;63:69‐79. - PubMed
    1. Singman HS, Berman SN, Cowell C, Maslansky E, Archer M. The Anti‐Coronary Club: 1957‐1972. American Journal of Clinical Nutrition 1980;33(6):1183‐91. - PubMed
Aquilani 2000 {published data only}
    1. Aquilani R, Tramarin R, Pedretti RFE, Bertolotti G, Sommaruga M, Mariani P, et al. Can a very‐low‐fat diet achieve cholesterol goals in CAD?. Cardiology Review 2000;17(10):36‐40.
Arntzenius 1985 {published data only}
    1. Arntzenius AC, Kromhout D, Bartn JE, Reiber JHC, Bruschke AVG, Buis Van Gent CM. Diet, lipoprotiens and progression of coronary atherosclerosis: The leiden intervention trial. New England Journal of Medicine 1985;312:805‐8. - PubMed
Aro 1990 {published data only}
    1. Aro A, Ahola I, Jauhiainen M, et al. Effects of plasma phospholipid fatty acids of rapeseed oil and sunflower oil diets [Abstract]. Arteriosclerosis 1990;10:877a.
ASSIST 2001 {published data only}
    1. Moher M, Yudkin P, Wright L, Turner R, Fuller A, Schofield T, et al. Cluster randomised controlled trial to compare three methods of promoting secondary prevention of coronary heart disease in primary care. BMJ 2001;322(7298):1338. - PMC - PubMed
Australian Polyp Prev 95 {published and unpublished data}
    1. MacLennan R. Effect of fat, fibre and beta‐carotene on colorectal adenomas after 24 months. Gastroenterology 1991;100:A382.
    1. MacLennan R, Macrae F, Bain C, Battistutta D, Chapuis P, Gratten H, et al. Randomized trial of intake of fat, fiber, and beta carotene to prevent colorectal adenomas. The Australian Polyp Prevention Project. Journal of the National Cancer Institute 1995;87(23):1760‐6. - PubMed
    1. Macrae FA, Hughes NR, Bhathal PS, Tay D, Selbie L, MacLennan R. Dietary suppression of rectal epthelial cell proliferation. Gastroenterology 1991;100:A383.
Baer 1993 {published data only}
    1. Baer JT. Improved plasma cholesterol levels in men after a nutrition education program at the worksite. Journal of the American Dietetic Association 1993;93(6):658‐63. - PubMed
Bakx 1997 {published data only}
    1. Bakx JC, Stafleu A, van SW, van‐den HH, van WC. Long‐term effect of nutritional counseling: a study in family medicine. American Journal of Clinical Nutrition 1997;65(6 Suppl):1946S‐50S. - PubMed
Barnard 2009 {published data only}
    1. Barnard ND, Cohen J, Jenkins DJ, Turner‐McGrievy G, Gloede L, Green A, et al. A low‐fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74‐wk clinical trial. American Journal of Clinical Nutrition 2009;89(5):1588S‐96S. - PMC - PubMed
Barndt 1977 {published data only}
    1. Barndt R, Blankenhorn CH, Crawford DW, et al. Regression and progression of early femoral atherosclerosis in treated hyperlipidaemic patients. Annals of Internal Medicine 1977;86:139‐46. - PubMed
Baron 1990 {published data only}
    1. Baron JA, Gleason R, Crowe B, Mann JI. Preliminary trial of the effect of general practice based nutritional advice. British Journal of General Practice 1990;40(333):137‐41. - PMC - PubMed
Barr 1990 {published data only}
    1. Barr SL, Ramakrishnan R, Holleran S. A 30% fat diet high in polyunsaturates and a 30% fat diet high in monounsaturates both lower total and low density lipoprotein cholesterol levels in normal males [Abstract]. Arteriosclerosis 1990;10:872a.
Baumann 1982 {published data only}
    1. Baumann J, Martschick R. Therapy of hyperlipidemia with xanthinol nicotinate as opposed to low fat diet [Therapie der Hyperlipidämie mit Xantinolnicotinat gegenüber fettarmer Diät]. Die Medizinische Welt 1982;33(4):139‐41. - PubMed
Beckmann 1988 {published data only}
    1. Beckmann SL, Os I, Kjeldsen SE, Mogensen B, Norum KR, Hjermann I. Non‐pharmacological treatment of mild to moderate hypertension. A randomized, controlled study‐‐results 1 1/2 years later. Tidsskrift For Den Norske Laegeforening 1988;108:1593‐7. - PubMed
Beckmann 1995 {published data only}
    1. Beckmann SL, Os I, Kjeldsen SE, Eide IK, Westheim AS, Hjermann I. Effect of dietary counselling on blood pressure and arterial plasma catecholamines in primary hypertension. American Journal of Hypertension 1995;8(7):704‐11. - PubMed
Beresford 1992 {published data only}
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Bloemberg 1991 {published and unpublished data}
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Bloomgarden 1987 {published data only}
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Bonnema 1995 {published data only}
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Bosaeus 1992 {published data only}
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Boyar 1988 {published data only}
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Bruno 1983 {published data only}
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Caggiula 1996 {published data only}
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Cerin 1993 {published data only}
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Chicago CPEP 1977 {published data only}
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Chiostri 1988 {published data only}
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Choudhury 1984 {published data only}
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Clifton 1992 {published data only}
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Cobb 1991 {published data only}
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Cohen 1991 {published data only}
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Colquhoun 1990 {published data only}
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Croft 1986 {published data only}
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Da Qing IGT 1997 {published data only}
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DAS 2000 {published data only}
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DASH 1997 {published data only}
    1. Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, et al. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. New England Journal of Medicine 1997;336(16):1117‐24. - PubMed
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Davey Smith 2005 {published data only}
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de Boer 1983 {published data only}
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de Bont 1981 {published and unpublished data}
    1. Bont AJ, Baker IA, St, Sweetnam PM, Wragg KG, Stephens SM, Hayes TM. A randomised controlled trial of the effect of low fat diet advice on dietary response in insulin independent diabetic women. Diabetologia 1981;21(6):529‐33. - PubMed
DeBusk 1994 {published data only}
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Delahanty 2001 {published data only}
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Demark 1990 {published data only}
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Dengel 1995 {published data only}
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Diabetes CCT 1995 {published data only}
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DIET 1998 {published data only}
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Duffield 1982 {published data only}
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Eating Patterns 1997 {published and unpublished data}
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Ehnholm 1982 {published data only}
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Ehnholm 1984 {published data only}
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Eisenberg 1990 {published data only}
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Elder 2000 {published data only}
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Ellegard 1991 {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 Diabet Prev 2000 {published data only}
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Finnish Mental Hosp 1972 {published data only}
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Fisher 1981 {published data only}
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Fleming 2002 {published data only}
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Ginsberg 1988 {published data only}
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Gjone 1972 {published data only}
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Hellenius Diet & Ex 95 {published and unpublished data}
    1. Hellenius ML, Brismar KE, Berglund BH, Faire U. 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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Hellenius Diet 1995 {published and unpublished data}
    1. Hellenius ML, Brismar KE, Berglund BH, Faire U. 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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    1. Hellenius ML, Faire U, Berglund B, Hamsten A, Krakau I. Diet and exercise are equally effective in reducing risk for cardiovascular disease. Results of a randomized controlled study in men with slightly to moderately raised cardiovascular risk factors. Atherosclerosis 1993;103(1):81‐91. - PubMed
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