Low-Fat Dietary Pattern and Risk of Invasive Breast Cancer: The Women's Health Initiative Randomized Controlled Dietary Modification Trial
Abstract
CONTEXT: The hypothesis that a low-fat dietary pattern can reduce breast cancer risk has existed for decades but has never been tested in a controlled intervention trial. OBJECTIVE: To assess the effects of undertaking a low-fat dietary pattern on breast cancer incidence. DESIGN AND SETTING: A randomized, controlled, primary prevention trial conducted at 40 US clinical centers from 1993 to 2005. PARTICIPANTS: A total of 48,835 postmenopausal women, aged 50 to 79 years, without prior breast cancer, including 18.6% of minority race/ethnicity, were enrolled. INTERVENTIONS: Women were randomly assigned to the dietary modification intervention group (40% [n = 19,541]) or the comparison group (60% [n = 29,294]). The intervention was designed to promote dietary change with the goals of reducing intake of total fat to 20% of energy and increasing consumption of vegetables and fruit to at least 5 servings daily and grains to at least 6 servings daily. Comparison group participants were not asked to make dietary changes. MAIN OUTCOME MEASURE: Invasive breast cancer incidence. RESULTS: Dietary fat intake was significantly lower in the dietary modification intervention group compared with the comparison group. The difference between groups in change from baseline for percentage of energy from fat varied from 10.7% at year 1 to 8.1% at year 6. Vegetable and fruit consumption was higher in the intervention group by at least 1 serving per day and a smaller, more transient difference was found for grain consumption. The number of women who developed invasive breast cancer (annualized incidence rate) over the 8.1-year average follow-up period was 655 (0.42%) in the intervention group and 1072 (0.45%) in the comparison group (hazard ratio, 0.91; 95% confidence interval, 0.83-1.01 for the comparison between the 2 groups). Secondary analyses suggest a lower hazard ratio among adherent women, provide greater evidence of risk reduction among women having a high-fat diet at baseline, and suggest a dietary effect that varies by hormone receptor characteristics of the tumor. CONCLUSIONS: Among postmenopausal women, a low-fat dietary pattern did not result in a statistically significant reduction in invasive breast cancer risk over an 8.1-year average follow-up period. However, the nonsignificant trends observed suggesting reduced risk associated with a low-fat dietary pattern indicate that longer, planned, nonintervention follow-up may yield a more definitive comparison. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.
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Low-carbohydrate patterns generally refer to patterns with total carbohydrate targets between 20% and 40% of kilocalories.
“Low-carbohydrate patterns generally refer to patterns with total carbohydrate targets between 20% and 40% of kilocalaroies.20,[29][30][31][32][33][34][35][36]”
From Popular dietary patterns: alignment with American Heart Association 2021 dietary guidance: a scientific statement from the American Heart Association. (2023) · cites this paper as [33]
Low-fat patterns generally target total fat intake between 20% and 30% of kilocalories alongside other healthy dietary guidelines.
“Low-fat patterns generally target total fat intake between 20% and 30% of kilocalories alongside other healthy dietary guidelines.20,[29][30][31][32][33][34][35][36]”
From Popular dietary patterns: alignment with American Heart Association 2021 dietary guidance: a scientific statement from the American Heart Association. (2023) · cites this paper as [33]
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- Authors
- Prentice, R. L., Caan, B., Chlebowski, R. T., Patterson, R., Kuller, L. H., Ockene, J. K., Margolis, K. L., Limacher, M. C., Manson, J. E., Parker, L. M., Paskett, E., Phillips, L., Robbins, J., Rossouw, J. E., Sarto, G. E., Shikany, J. M., Stefanick, M. L., Thomson, C. A., Van Horn, L., Vitolins, M. Z., Wactawski-Wende, J., Wallace, R. B., Wassertheil-Smoller, S., Whitlock, E., Yano, K., Adams-Campbell, L., Anderson, G. L., Assaf, A. R., Beresford, S. A. A., Black, H. R., Brunner, R. L., Brzyski, R. G., Ford, L., Gass, M., Hays, J., Heber, D., Heiss, G., Hendrix, S. L., Hsia, J., Hubbell, F. A., Jackson, R. D., Johnson, K. C., Kotchen, J. M., LaCroix, A. Z., Lane, D. S., Langer, R. D., Lasser, N. L., & Henderson, M. M.
- Affiliations
- Fred Hutch Cancer Center (US)
- Corresponding author
- Prentice, Ross L.
- ORCID
- Prentice, Ross L.
- Caan, Bette
- Chlebowski, Rowan T.
- Patterson, Ruth
- Kuller, Lewis H.
- Ockene, Judith K.
- Margolis, Karen L.
- Limacher, Marian C.
- Manson, JoAnn E.
- Paskett, Electra
- Phillips, Lawrence
- Rossouw, Jacques E.
- Shikany, James M.
- Stefanick, Marcia L.
- Thomson, Cynthia A.
- Vitolins, Mara Z.
- Wallace, Robert B.
- Wassertheil-Smoller, Sylvia
- Whitlock, Evelyn
- Adams-Campbell, Lucile
- Anderson, Garnet L.
- Assaf, Annlouise R.
- Beresford, Shirley A. A.
- Brunner, Robert L.
- Heiss, Gerardo
- Hsia, Judith
- Jackson, Rebecca D.
- Johnson, Karen C.
- LaCroix, Andrea Z.
- Lane, Dorothy S.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2006-02-08
- Volume
- 295
- Issue
- 6
- Pages
- 629
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2735620790
- Cited by
- 828
- References
- 55
- Citations by year
- 2026: 9 · 2025: 9 · 2024: 20 · 2023: 15 · 2022: 28 · 2021: 28 · 2020: 27 · 2019: 22 · 2018: 32 · 2017: 41 · 2016: 24 · 2015: 34 · 2014: 41 · 2013: 40 · 2012: 56
- FWCI
- 91.89
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- The Journal of the American Medical Association (JAMA) Network (American Medical Association) (submittedVersion)
- Funders
- U.S. Department of Health and Human Services
- Bristol-Myers Squibb
- Pfizer
- AstraZeneca
- Sanofi
- Women's Health Initiative
- Brigham and Women's Hospital
- Wake Forest University
- University of Minnesota
- University of Washington
- Mylan
- National Institutes of Health
- National Heart, Lung, and Blood Institute
- NIH Clinical Center
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Health Sciences › Medicine › Oncology › Cancer Risks and Factors
- Health Sciences › Medicine › Oncology › Global Cancer Incidence and Screening
- Keywords
- low-fat diet, invasive breast cancer, breast cancer prevention, dietary fat intake, postmenopausal women, dietary intervention, fruit and vegetable intake, grain consumption, hormone receptor status, primary prevention, dietary adherence, minority women, cancer risk reduction, Women's Health Initiative
- MeSH terms
- Aged, Body Weight, Breast Neoplasms, Female, Follow-Up Studies, Humans, Cholesterol, LDL, Middle Aged, Primary Prevention, Risk, Sex Hormone-Binding Globulin, Gonadal Steroid Hormones, Biomarkers, Diet Records, Incidence, Proportional Hazards Models, Postmenopause, Diet, Fat-Restricted
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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