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One-Year Results of the PREDIMED Randomized Trial

Jordi Salas-Salvadó, MD, PhD; Joan Fernández-Ballart, MD, PhD; Emilio Ros, MD, PhD; Miguel-Angel Martínez-González, MD, PhD; Montserrat Fitó, MD, PhD; Ramon Estruch, MD, PhD; Dolores Corella, DPharm, PhD; Miquel Fiol, MD, PhD; Enrique Gómez-Gracia, MD, PhD; Fernando Arós, MD, PhD; Gemma Flores, MD; José Lapetra, MD, PhD; Rosa Lamuela-Raventós, DPharm, PhD; Valentina Ruiz-Gutiérrez, DPharm, PhD; Mònica Bulló, PhD; Josep Basora, MD; María-Isabel Covas, DPharm, PhD; for the PREDIMED Study Investigators

Arch Intern Med. 2008;168(22):2449-2458.

Background  Epidemiological studies suggest that the Mediterranean diet (MedDiet) may reduce the risk of developing the metabolic syndrome (MetS). We compared the 1-year effect of 2 behavioral interventions to implement the MedDiet vs advice on a low-fat diet on MetS status.

Methods  A total of 1224 participants were recruited from the PREDIMED (Prevención con Dieta Mediterránea) Study, a multicenter, 3-arm, randomized clinical trial to determine the efficacy of the MedDiet on the primary prevention of cardiovascular disease. Participants were older subjects at high risk for cardiovascular disease. Interventions were quarterly education about the MedDiet plus provision of either 1 L/wk of virgin olive oil (MedDiet + VOO) or 30 g/d of mixed nuts (MedDiet + nuts), and advice on a low-fat diet (control diet). All diets were ad libitum, and there was no increase in physical activity for any of the interventions. Lifestyle variables and MetS features as defined by the National Cholesterol Education Program Adult Treatment Panel III criteria were assessed.

Results  At baseline, 61.4% of participants met criteria for the MetS. One-year prevalence was reduced by 6.7%, 13.7%, and 2.0% in the MedDiet + VOO, MedDiet + nuts, and control diet groups, respectively (MedDiet + nuts vs control groups, P = .01; MedDiet + VOO vs control group, P  = .18). Incident rates of the MetS were not significantly different among groups (22.9%, 17.9%, and 23.4%, respectively). After adjustment for sex, age, baseline obesity status, and weight changes, the odds ratios for reversion of MetS were 1.3 (95% confidence interval, 0.8-2.1) for the MedDiet + VOO group and 1.7 (1.1-2.6) for the MedDiet + nuts group compared with the control diet group.

Conclusion  A traditional MedDiet enriched with nuts could be a useful tool in the management of the MetS.

Trial Registration  clinicaltrials.gov Identifier: ISRCTN35739639

Author Affiliations: Human Nutrition, Preventive Medicine, and Public Health Units, School of Medicine, University of Rovira i Virgili, Reus (Drs Salas-Salvadó, Fernández-Ballart, Bulló, and Basora); Lipid Clinic, Endocrinology and Nutrition Service (Dr Ros), and Department of Internal Medicine (Dr Estruch), Hospital Clinic, Institut Investigacions Biomèdiques August Pi i Sunyer, and Lipids and Cardiovascular Epidemiology Unit, Institut Municipal Investigació Mèdica, Barcelona (Drs Fitó and Covas); Department of Preventive Medicine and Public Health, University Clinic, University of Navarra, Pamplona (Dr Martínez-González); Department of Preventive Medicine and Public Health, School of Medicine, University of València, València (Dr Corella); University Institute for Health Sciences Investigation, Palma de Mallorca (Dr Fiol); Department of Epidemiology, School of Medicine, University of Málaga, Málaga (Dr Gómez-Gracia); Department of Cardiology, Hospital Txagorritxu, Vitoria (Dr Arós); Primary Health Care Division, Catalan Institute of Health, Barcelona (Dr Flores); Department of Family Medicine, Primary Care Division of Sevilla, San Pablo Health Center, Sevilla (Dr Lapetra); Department of Nutrition and Bromatology, School of Pharmacy, University of Barcelona, Barcelona (Dr Lamuela-Raventós); Instituto de la Grasa, Consejo Superior de Investigaciones Científicas, Sevilla (Dr Ruiz-Gutiérrez); and Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y Nutrición, Instituto de Salud Carlos III, Santiago de Compostela (Drs Salas-Salvadó, Fernández-Ballart, Ros, Fitó, Estruch, Corella, Fiol, Lapetra, Bulló, and Covas), Spain.

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