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Cited by 92Nutritional Studies and DietCardiovascular Health and Risk FactorsLipoproteins and Cardiovascular Health

Low-fat dietary pattern and cardiovascular disease: results from the Women’s Health Initiative randomized controlled trial

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Prentice, Ross L, Aragaki, Aaron K, Van Horn, Linda, Thomson, Cynthia A, Beresford, Shirley AA, Robinson, Jennifer, Snetselaar, Linda, Anderson, Garnet L +4 more·2017·The American Journal of Clinical Nutrition
DOI 10.3945/ajcn.117.153270PMC PMC5486201
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Abstract

Background: The influence of a low-fat dietary pattern on the cardiovascular health of postmenopausal women continues to be of public health interest.Objective: This report evaluates low-fat dietary pattern influences on cardiovascular disease (CVD) incidence and mortality during the intervention and postintervention phases of the Women's Health Initiative Dietary Modification Trial.Design: Participants comprised 48,835 postmenopausal women aged 50-79 y; 40% were randomly assigned to a low-fat dietary pattern intervention (target of 20% of energy from fat), and 60% were randomly assigned to a usual diet comparison group. The 8.3-y intervention period ended in March 2005, after which >80% of surviving participants consented to additional active follow-up through September 2010; all participants were followed for mortality through 2013. Breast and colorectal cancer were the primary trial outcomes, and coronary heart disease (CHD) and overall CVD were additional designated outcomes.Results: Incidence rates for CHD and total CVD did not differ between the intervention and comparison groups in either the intervention or postintervention period. However, CHD HRs comparing these groups varied strongly with baseline CVD and hypertension status. Participants without prior CVD had an intervention period CHD HR of 0.70 (95% CI: 0.56, 0.87) or 1.04 (95% CI: 0.90, 1.19) if they were normotensive or hypertensive, respectively (P-interaction = 0.003). The CHD benefit among healthy normotensive women was partially offset by an increase in ischemic stroke risk. Corresponding HRs in the postintervention period were close to null. Participants with CVD at baseline (3.4%) had CHD HRs of 1.47 (95% CI: 1.12, 1.93) and 1.61 (95% CI: 1.02, 2.55) in the intervention and postintervention periods, respectively. However, various lines of evidence suggest that results in women with CVD or hypertension at baseline are confounded by postrandomization use of cholesterol-lowering medications.Conclusions: CVD risk in postmenopausal women appears to be sensitive to a change to a low-fat dietary pattern and, among healthy women, includes both CHD benefit and stroke risk. This trial was registered at clinicaltrials.gov as NCT00000611.

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  • 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 [39]

    The Introduction and Results (pages unavailable) report elevated coronary heart disease risk among women with prior CVD, supporting the cardiovascular-outcomes portion of the citation. They do not report a deterioration in all-cause mortality in that subgroup. The Introduction describes a modest LDL-cholesterol reduction overall, but the Discussion says LDL change in the prior-CVD intervention subgroup was comparatively unfavorable; it does not support an approximately 4 mg/dL reduction in that subgroup. (LLM, conf=0.87)

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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 [39]

    The Results and Abstract report elevated CHD incidence among women with CVD before enrollment. But the Discussion says LDL cholesterol did not fall as expected in the intervention group within that subgroup, and attributes its comparatively unfavorable change partly to differences in cholesterol-lowering medication use. The paper therefore does not support pairing the subgroup’s worse cardiovascular outcomes with an approximately 4 mg/dL LDL-C reduction; it also calls the subgroup’s CHD results uninterpretable because of confounding. Page numbers were not available in our copy. (LLM, conf=0.88)

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Authors
Prentice, R. L., Aragaki, A. K., Van Horn, L., Thomson, C. A., Beresford, S. A., Robinson, J., Snetselaar, L., Anderson, G. L., Manson, J. E., Allison, M. A., Rossouw, J. E., & Howard, B. V.
Affiliations
  • Fred Hutch Cancer Center (US)
  • University of Arizona (US)
  • University of Washington (US)
  • University of Iowa (US)
  • Brigham and Women's Hospital (US)
  • University of California San Diego (US)
  • National Heart, Lung, and Blood Institute (US)
  • Georgetown-Howard Universities Center for Clinical and Translational Science (US)
Corresponding author
Prentice, Ross L
ORCID
Venue
The American Journal of Clinical Nutrition
Publisher
Elsevier BV
Published
2017-07
Volume
106
Issue
1
Pages
35-43
ISSN
0002-9165 (ISSN-L)
DOI
10.3945/ajcn.117.153270
PMC
PMC5486201
OpenAlex
W2614884431
Cited by
91
References
19
Citations by year
2026: 2 · 2025: 7 · 2024: 10 · 2023: 10 · 2022: 7 · 2021: 14 · 2020: 19 · 2019: 8 · 2018: 12 · 2017: 1 · 2016: 1
FWCI
10.27
Type
journal article
Language
en
Open access
Licence
Locations
  • American Journal of Clinical Nutrition (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • U.S. Department of Health and Human Services (HHSN268201100002C, HHSN2682011 00003C, HHSN 268201100001C, HHSN268201100046C, HHSN268201100004C, HHSN-271-2011-00004C)
  • Brigham and Women's Hospital
  • MedStar Health Research Institute
  • National Institutes of Health (UL1TR001409, HHSN268201100004C, HHSN268201100046C, HHSN271201100004C, HHSN268201100001C, HHSN268201100002C, HHSN268201100003C)
  • National Heart, Lung, and Blood Institute (HHSN268201100004C, HHSN271201100004C, HHSN26820-1100002C, HHSN268201100046C, HHSN268201100001C, HHSN268201100003C)
  • National Cancer Institute (R01CA210921, P01CA053996, T32CA009686)
  • National Center for Advancing Translational Sciences
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, dietary fat reduction, cardiovascular disease, coronary artery disease, ischemic stroke, postmenopausal women, Women's Health Initiative Dietary Modification Trial, hypertension, breast cancer, colorectal cancer, cardiovascular mortality, dietary intervention, cardiovascular risk stratification, hormone replacement therapy
MeSH terms
Aged, Breast Neoplasms, Cardiovascular Diseases, Coronary Disease, Dietary Fats, Feeding Behavior, Female, Follow-Up Studies, Humans, Hypertension, Middle Aged, Risk Factors, Colorectal Neoplasms, Incidence, Women's Health, Postmenopause, Diet, Fat-Restricted, Stroke

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