• 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, and Miguel A Martínez-González.
• Department of Preventive Medicine and Public Health, University of Navarra-School of Medicine, Pamplona, Navarra, Spain2Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición, Instituto de Salud Carlos III, Madrid, Spain.
• JAMA Intern Med. 2015 Nov 1; 175 (11): 1752-60.

ImportanceBreast cancer is the leading cause of female cancer burden, and its incidence has increased by more than 20% worldwide since 2008. Some observational studies have suggested that the Mediterranean diet may reduce the risk of breast cancer.ObjectiveTo evaluate the effect of 2 interventions with Mediterranean diet vs the advice to follow a low-fat diet (control) on breast cancer incidence.Design, Setting, And ParticipantsThe 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.InterventionsParticipants were randomly allocated to a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat).Main Outcomes And MeasuresBreast cancer incidence was a prespecified secondary outcome of the trial for women without a prior history of breast cancer (n = 4152).ResultsAfter 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 RelevanceThis 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 RegistrationISRCTN.org Identifier: ISRCTN35739639.

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