Mediterranean Diet and Invasive Breast Cancer Risk Among Women at High Cardiovascular Risk in the PREDIMED Trial: A Randomized Clinical Trial.
Abstract | IMPORTANCE: OBJECTIVE: DESIGN, SETTING, AND PARTICIPANTS: The PREDIMED study is a 1:1:1 randomized, single-blind, controlled field trial conducted at primary health care centers in Spain. From 2003 to 2009, 4282 women aged 60 to 80 years and at high cardiovascular disease risk were recruited after invitation by their primary care physicians. INTERVENTIONS: MAIN OUTCOMES AND MEASURES:
Breast cancer incidence was a prespecified secondary outcome of the trial for women without a prior history of breast cancer (n = 4152). RESULTS: After a median follow-up of 4.8 years, we identified 35 confirmed incident cases of breast cancer. Observed rates (per 1000 person-years) were 1.1 for the Mediterranean diet with extra-virgin olive oil group, 1.8 for the Mediterranean diet with nuts group, and 2.9 for the control group. The multivariable-adjusted hazard ratios vs the control group were 0.32 (95% CI, 0.13-0.79) for the Mediterranean diet with extra-virgin olive oil group and 0.59 (95% CI, 0.26-1.35) for the Mediterranean diet with nuts group. In analyses with yearly cumulative updated dietary exposures, the hazard ratio for each additional 5% of calories from extra-virgin olive oil was 0.72 (95% CI, 0.57-0.90). CONCLUSIONS AND RELEVANCE: This is the first randomized trial finding an effect of a long-term dietary intervention on breast cancer incidence. Our results suggest a beneficial effect of a Mediterranean diet supplemented with extra-virgin olive oil in the primary prevention of breast cancer. These results come from a secondary analysis of a previous trial and are based on few incident cases and, therefore, need to be confirmed in longer-term and larger studies. TRIAL REGISTRATION: ISRCTN.org Identifier: ISRCTN35739639.
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Authors | Estefanía Toledo, Jordi Salas-Salvadó, Carolina Donat-Vargas, Pilar Buil-Cosiales, Ramón Estruch, Emilio Ros, Dolores Corella, Montserrat Fitó, Frank B Hu, Fernando Arós, Enrique Gómez-Gracia, Dora Romaguera, Manuel Ortega-Calvo, Lluís Serra-Majem, Xavier Pintó, Helmut Schröder, Josep Basora, José Vicente Sorlí, Mònica Bulló, Merce Serra-Mir, Miguel A Martínez-González |
Journal | JAMA internal medicine
(JAMA Intern Med)
Vol. 175
Issue 11
Pg. 1752-1760
(Nov 2015)
ISSN: 2168-6114 [Electronic] United States |
PMID | 26365989
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
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Topics |
- Aged
- Breast Neoplasms
(diet therapy, epidemiology, prevention & control)
- Cardiovascular Diseases
(epidemiology, prevention & control)
- Diet, Mediterranean
(psychology, statistics & numerical data)
- Dietary Fats
- Female
- Follow-Up Studies
- Humans
- Incidence
- Middle Aged
- Nuts
- Olive Oil
- Primary Prevention
(methods, statistics & numerical data)
- Risk Reduction Behavior
- Time
- Treatment Outcome
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