Low-Fat Dietary Pattern and Risk of Cardiovascular Disease: The Women's Health Initiative Randomized Controlled Dietary Modification Trial
Abstract
CONTEXT: Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed. OBJECTIVE: To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of 48,835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19,541 [40%]) or comparison group (29,294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years. INTERVENTION: Intensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials. MAIN OUTCOME MEASURES: Fatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke). RESULTS: By year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits. CONCLUSIONS: Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.
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Deterioration in cardiovascular outcomes was reported in secondary prevention subpopulations of the Women's Health Initiative despite an approximately 4 mg/dL reduction in LDL-C levels.
“However, deterioration in cardiovascular outcomes and all-cause mortality was reported in secondary prevention subpopulations despite an approximately 4 mg/dL reduction in LDL-C levels (38), (39).”
From Saturated Fat Restriction for Cardiovascular Disease Prevention: A Systematic Review and Meta-analysis of Randomized Controlled Trials (2025) · cites this paper as [38]
Deterioration in all-cause mortality was reported in secondary prevention subpopulations of the Women's Health Initiative despite an approximately 4 mg/dL reduction in LDL-C levels.
“However, deterioration in cardiovascular outcomes and all-cause mortality was reported in secondary prevention subpopulations despite an approximately 4 mg/dL reduction in LDL-C levels (38), (39).”
From Saturated Fat Restriction for Cardiovascular Disease Prevention: A Systematic Review and Meta-analysis of Randomized Controlled Trials (2025) · cites this paper as [38]
In the Women's Health Initiative, the largest RCT on total fat reduction, no difference in cardiovascular outcomes was observed among the whole study participants.
“In this largest RCT on total fat reduction, no difference in cardiovascular outcomes was observed among the whole study participants.”
From Saturated Fat Restriction for Cardiovascular Disease Prevention: A Systematic Review and Meta-analysis of Randomized Controlled Trials (2025) · cites this paper as [38]
The intervention of the Women's Health Initiative focused on a reduction in total fat but not in SFA.
“Finally, the intervention of the Women’s Health Initiative focused on a reduction in total fat but not in SFA (38).”
From Saturated Fat Restriction for Cardiovascular Disease Prevention: A Systematic Review and Meta-analysis of Randomized Controlled Trials (2025) · cites this paper as [38]
Observational studies indicate there might be no benefits if saturated fat reduction is associated with an increase in carbohydrates, supported by the absence of benefits from a low fat diet in the Women's Health Initiative.
“However, observational studies indicate that there might be no benefits if saturated fat reduction is associated with an increase in carbohydrates,91 which is also supported by the absence of benefits from a low fat diet in the Women’s Health Initiative.192”
The type of fats consumed appears far more relevant for cardiometabolic health than the proportion of calories consumed from total fat.
“However, the type of fats consumed appears to be far more relevant for cardiometabolic health than the proportion of calories consumed from total fat.61,133–135”
From Components of a Cardioprotective Diet: New Insights (2011) · cites this paper as [133]
Observational cohorts and randomized trials confirm that diets focused on isolated nutrient targets, such as low-fat, low-saturated fat diets, produce no significant benefits on cardiovascular disease, diabetes, or insulin resistance.
“In comparison, both observational cohorts and randomized trials confirm little clinical benefit of diets focused on isolated nutrient targets, such as low-fat, low-saturated fat diets, which produce no significant benefits on cardiovascular disease, diabetes, or insulin resistance.36-39”
From Dietary and Policy Priorities for Cardiovascular Disease, Diabetes, and Obesity: A Comprehensive Review (2016) · cites this paper as [37]
Observational cohorts and randomized trials confirm that diets focused on isolated nutrient targets, such as low-fat, low-saturated fat diets, produce no significant benefits on cardiovascular disease, diabetes, or insulin resistance.
“In comparison, both observational cohorts and randomized trials confirm little clinical benefit of diets focused on isolated nutrient targets, such as low-fat, low-saturated fat diets, which produce no significant benefits on cardiovascular disease, diabetes, or insulin resistance.36-39”
From Dietary and Policy Priorities for Cardiovascular Disease, Diabetes, and Obesity: A Comprehensive Review (2016) · cites this paper as [36]
The large WHI randomized trial substantially lowered total dietary fat among nearly 50,000 US women followed for nearly a decade, and did not show benefits for any major endpoint including heart disease, stroke, cancers, diabetes, or insulin resistance.
“The large WHI randomized trial substantially lowered total dietary fat among nearly 50,000 US women followed for nearly a decade, and did not show benefits for any major endpoint including heart disease (Figure 2, top panel), stroke, cancers, diabetes, or insulin resistance.36-39”
From Dietary and Policy Priorities for Cardiovascular Disease, Diabetes, and Obesity: A Comprehensive Review (2016) · cites this paper as [36]
The large WHI randomized trial substantially lowered total dietary fat among nearly 50,000 US women followed for nearly a decade, and did not show benefits for any major endpoint including heart disease, stroke, cancers, diabetes, or insulin resistance.
“The large WHI randomized trial substantially lowered total dietary fat among nearly 50,000 US women followed for nearly a decade, and did not show benefits for any major endpoint including heart disease (Figure 2, top panel), stroke, cancers, diabetes, or insulin resistance.36-39”
From Dietary and Policy Priorities for Cardiovascular Disease, Diabetes, and Obesity: A Comprehensive Review (2016) · cites this paper as [37]
Low-fat diets have not been particularly effective for long-term CVD risk reduction, partly due to difficulty sustaining such a diet long-term.
“It bears mention that low-fat diets have not been particularly effective for long-term CVD risk reduction, partly due to the difficulty sustaining such a diet long-term (284,285).”
From Food Consumption and its Impact on Cardiovascular Disease: Importance of Solutions Focused on the Globalized Food System (2015) · cites this paper as [284]
In the Framingham Heart Study Offspring Cohort (n=2730), subjects in the highest quintile for Mediterranean-style dietary pattern score had the lowest triglyceride levels (103 versus 114 mg/dL, P<0.001) over a 7-year follow-up.
“In the Framingham Heart Study Offspring Cohort (nϭ2730), subjects in the highest quintile for Mediterranean-style dietary pattern score had the lowest triglyceride levels (103 versus 114 mg/dL, PϽ0.001) over a 7-year follow-up.398”
From Triglycerides and Cardiovascular Disease: A Scientific Statement From the American Heart Association (2011) · cites this paper as [398]
Mediterranean-style dietary pattern is associated with decreased triglyceride levels.
“Epidemiological and clinical trial evidence suggests that the Mediterranean-style dietary pattern 398,399 is associated with decreased triglyceride levels.”
From Triglycerides and Cardiovascular Disease: A Scientific Statement From the American Heart Association (2011) · cites this paper as [398]
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- Authors
- Howard, B. V., Van Horn, L., Hsia, J., Manson, J. E., Stefanick, M. L., Wassertheil-Smoller, S., Kuller, L. H., LaCroix, A. Z., Langer, R. D., Lasser, N. L., Lewis, C. E., Limacher, M. C., Margolis, K. L., Mysiw, W. J., Ockene, J. K., Parker, L. M., Perri, M. G., Phillips, L., Prentice, R. L., Robbins, J., Rossouw, J. E., Sarto, G. E., Schatz, I. J., Snetselaar, L. G., Stevens, V. J., Tinker, L. F., Trevisan, M., Vitolins, M. Z., Anderson, G. L., Assaf, A. R., Bassford, T., Beresford, S. A. A., Black, H. R., Brunner, R. L., Brzyski, R. G., Caan, B., Chlebowski, R. T., Gass, M., Granek, I., Greenland, P., Hays, J., Heber, D., Heiss, G., Hendrix, S. L., Hubbell, F. A., Johnson, K. C., & Kotchen, J. M.
- Affiliations
- Howard University (US)
- George Washington University (US)
- Harvard University (US)
- Stanford University (US)
- Yeshiva University (US)
- University of Pittsburgh (US)
- Fred Hutch Cancer Center (US)
- University of California San Diego (US)
- Rutgers, The State University of New Jersey (US)
- University of Alabama at Birmingham (US)
- University of Florida (US)
- University of Minnesota (US)
- The Ohio State University (US)
- University of Massachusetts Chan Medical School (US)
- University of Miami (US)
- Emory University (US)
- University of California, Davis (US)
- National Institutes of Health (US)
- University of Wisconsin–Madison (US)
- University of Hawaiʻi at Mānoa (US)
- University of Iowa (US)
- Kaiser Permanente (US)
- University at Buffalo, State University of New York (US)
- Wake Forest University (US)
- Pfizer (United States) (US)
- University of Arizona (US)
- Rush University (US)
- University of Nevada, Reno (US)
- The University of Texas at San Antonio (US)
- University of California, Los Angeles (US)
- University of Cincinnati (US)
- Stony Brook University (US)
- Northwestern University (US)
- University of North Carolina at Chapel Hill (US)
- Wayne State University (US)
- University of California, Irvine (US)
- University of Tennessee Health Science Center (US)
- Medical College of Wisconsin (US)
- ORCID
- Howard, Barbara V.
- Hsia, Judith
- Manson, JoAnn E.
- Stefanick, Marcia L.
- Wassertheil-Smoller, Sylvia
- Kuller, Lewis H.
- LaCroix, Andrea Z.
- Lewis, Cora E.
- Limacher, Marian C.
- Margolis, Karen L.
- Ockene, Judith K.
- Perri, Michael G.
- Phillips, Lawrence
- Prentice, Ross L.
- Robbins, John
- Rossouw, Jacques E.
- Snetselaar, Linda G.
- Tinker, Lesley F.
- Trevisan, Maurizio
- Vitolins, Mara Z.
- Anderson, Garnet L.
- Assaf, Annlouise R.
- Bassford, Tamsen
- Beresford, Shirley A. A.
- Brunner, Robert L.
- Caan, Bette
- Chlebowski, Rowan T.
- Greenland, Philip
- Heiss, Gerardo
- Johnson, Karen C.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2006-02-08
- Volume
- 295
- Issue
- 6
- Pages
- 655
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2112728975
- Cited by
- 1,091
- References
- 50
- Citations by year
- 2026: 11 · 2025: 16 · 2024: 18 · 2023: 29 · 2022: 32 · 2021: 44 · 2020: 49 · 2019: 38 · 2018: 54 · 2017: 45 · 2016: 45 · 2015: 63 · 2014: 54 · 2013: 80 · 2012: 64
- FWCI
- 103.20
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- eScholarship@UMassChan (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Risk Factors
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Keywords
- low-fat diet, cardiovascular disease prevention, coronary artery disease, stroke, postmenopausal women, dietary intervention, behavior modification, fat intake reduction, fruit and vegetable intake, grain consumption, LDL cholesterol, blood pressure, Women's Health Initiative Dietary Modification Trial, cardiovascular risk factors
- MeSH terms
- Aged, Energy Intake, Cardiovascular Diseases, Coronary Disease, Fatty Acids, Female, Follow-Up Studies, Humans, Middle Aged, Primary Prevention, Risk, Risk Factors, Incidence, Proportional Hazards Models, Outcome Assessment, Health Care, Postmenopause, Diet, Fat-Restricted, Stroke
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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