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CMAJ. 2014 Nov 18;186(17):E649-57. doi: 10.1503/cmaj.140764. Epub 2014 Oct 14.

Mediterranean diets and metabolic syndrome status in the PREDIMED randomized trial.

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Human Nutrition Unit (Babio, Bulló, Basora, Salas-Salvadó), Faculty of Medicine and Health Sciences, Biochemistry Biotechnology Department, Universitat Rovira i Virgili, and Hospital Universitari de Sant Joan de Reus, IISPV, Reus, Spain; Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERobn) (Babio, Toledo, Estruch, Martínez-González, Castañer, Bulló, Corella, Arós, Gómez-Gracia, Ruiz-Gutiérrez, Fiol, Lapetra, Lamuela-Raventos, Serra-Majem, Pintó, Basora, Sorlí, Salas-Salvadó), Institute of Health Carlos III, Madrid, Spain; Department of Preventive Medicine and Public Health (Toledo, Martínez-González), University of Navarra, Pamplona, Spain; Department of Internal Medicine (Estruch), Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic, University of Barcelona, Barcelona, Spain; Lipid Clinic (Ros), Endocrinology and Nutrition Service, IDIBAPS, Hospital Clinic, University of Barcelona, Barcelona, Spain; Cardiovascular Risk and Nutrition Research Group (Castañer), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona Biomedical Research Park, Barcelona, Spain; Department of Preventive Medicine (Corella, Sorlí), University of Valencia, València, Spain; Department of Cardiology (Arós), University Hospital Txagorritxu, Vitoria, Spain; Department of Preventive Medicine (Gómez-Gracia), University of Malaga, Malaga, Spain; Instituto de la Grasa (Ruiz-Gutiérrez), Consejo Superior de Investigaciones Cientificas, Seville; Instituto de Investigación Sanitaria de Palma (Fiol), Hospital Universitario Son Espases, Mallorca; Department of Family Medicine (Lapetra), Primary Care Division of Seville, San Pablo Health Center, Seville; Department of Nutrition and Food Science (Lamuela-Raventos), School of Pharmacy, Xarxa de Referència en Tecnologia dels Aliments, Instituto de Investigación en Nutrición y Seguridad Alimentaria, University of Barcelona, Barcelona, Spain; De



Little evidence exists on the effect of an energy-unrestricted healthy diet on metabolic syndrome. We evaluated the long-term effect of Mediterranean diets ad libitum on the incidence or reversion of metabolic syndrome.


We performed a secondary analysis of the PREDIMED trial--a multicentre, randomized trial done between October 2003 and December 2010 that involved men and women (age 55-80 yr) at high risk for cardiovascular disease. Participants were randomly assigned to 1 of 3 dietary interventions: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with nuts or advice on following a low-fat diet (the control group). The interventions did not include increased physical activity or weight loss as a goal. We analyzed available data from 5801 participants. We determined the effect of diet on incidence and reversion of metabolic syndrome using Cox regression analysis to calculate hazard ratios (HRs) and 95% confidence intervals (CIs).


Over 4.8 years of follow-up, metabolic syndrome developed in 960 (50.0%) of the 1919 participants who did not have the condition at baseline. The risk of developing metabolic syndrome did not differ between participants assigned to the control diet and those assigned to either of the Mediterranean diets (control v. olive oil HR 1.10, 95% CI 0.94-1.30, p = 0.231; control v. nuts HR 1.08, 95% CI 0.92-1.27, p = 0.3). Reversion occurred in 958 (28.2%) of the 3392 participants who had metabolic syndrome at baseline. Compared with the control group, participants on either Mediterranean diet were more likely to undergo reversion (control v. olive oil HR 1.35, 95% CI 1.15-1.58, p < 0.001; control v. nuts HR 1.28, 95% CI 1.08-1.51, p < 0.001). Participants in the group receiving olive oil supplementation showed significant decreases in both central obesity and high fasting glucose (p = 0.02); participants in the group supplemented with nuts showed a significant decrease in central obesity.


A Mediterranean diet supplemented with either extra virgin olive oil or nuts is not associated with the onset of metabolic syndrome, but such diets are more likely to cause reversion of the condition. An energy-unrestricted Mediterranean diet may be useful in reducing the risks of central obesity and hyperglycemia in people at high risk of cardiovascular disease.


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