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Title: Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trial
Author: Toledo, Estefanía
Salas Salvadó, Jordi
Donat Vargas, Carolina
Buil-Cosiales, Pilar
Estruch Riba, Ramon
Ros Rahola, Emilio
Corella Piquer, Dolores
Fitó Colomer, Montserrat
Hu, Frank B.
Arós, Fernando
Gómez Gracia, Enrique
Romaguera, Dora
Ortega Calvo, Manuel
Serra Majem, Lluís
Pintó Sala, Xavier
Schröder, Helmut
Basora-Gallisá, Josep
Sorlí, José V.
Bulló, Mònica
Serra-Mir, Mercè
Martínez-González, Miguel Ángel, 1957-
Keywords: Assaigs clínics
Cuina mediterrània
Medicina preventiva
Càncer de mama
Clinical trials
Mediterranean cooking
Preventive medicine
Breast cancer
Issue Date: Nov-2015
Publisher: American Medical Association
Abstract: IMPORTANCE: Breast 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. OBJECTIVE: To 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 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: Participants 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 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.
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It is part of: JAMA Internal Medicine, 2015, vol. 175, num. 11, p. 1752-1760
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ISSN: 2168-6106
Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
Articles publicats en revistes (Medicina)

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