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CIBERobn is an initiative of ISCIII, Spain. Supported by the official funding agency for biomedical research of the Spanish government, Instituto de Salud Carlos III (ISCIII), through grants provided to research networks specifically developed for the trial (RTIC G03/140, to Ramon Estruch; RTIC RD 06/0045, to Miguel Martinez-Gonzalez and through Centro de Investigacion Biomedica en Red de Fisiopatologia de la Obesidad y Nutricion [CIBERobn]), and by grants from Centro Nacional de Investigaciones Cardiovasculares (CNIC 06/2007), Fondo de Investigacion Sanitaria-Fondo Europeo de Desarrollo Regional (PI04-2239, PI 05/2584, CP06/00100, PI07/0240, PI07/1138, PI07/0954, PI 07/0473, PI10/01407, PI10/02658, PI11/01647, and P11/02505; PI13/00462), Ministerio de Ciencia e Innovacion (AGL-2009-13906-C02 and AGL2010-22319-C03), Fundacion Mapfre 2010, Consejeria de Salud de la Junta de Andalucia (PI0105/2007), Public Health Division of the Department of Health of the Autonomous Government of Catalonia, Generalitat Valenciana (ACOMP06109, GVA-COMP2010-181, GVACOMP2011-151, CS2010-AP-111, and CS2011-AP-042), and Regional Government of Navarra (P27/2011). None of the funding sources played a role in the design, collection, analysis or interpretation of the data or in the decision to submit the manuscript for publication.

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Mediterranean diets and metabolic syndrome status in the PREDIMED randomized trial

Publicated to:Canadian Medical Association Journal. 186 (17): E649-E657 - 2014-11-18 186(17), DOI: 10.1503/cmaj.140764

Authors: Babio, Nancy; Toledo, Estefania; Estruch, Ramon; Ros, Emilio; Martinez-Gonzalez, Miguel A.; Castaner, Olga; Bullo, Monica; Corella, Dolores; Aros, Fernando; Gomez-Gracia, Enrique; Ruiz-Gutierrez, Valentina; Fiol, Miquel; Lapetra, Jose; Lamuela-Raventos, Rosa M.; Serra-Majem, Lluis; Pinto, Xavier; Basora, Josep; Sorli, Jose V.; Salas-Salvado, Jordi;PREDIMED Study Investigators

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Abstract

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.ClinicalTrials.gov, no. ISRCTN35739639.© 2014 Canadian Medical Association or its licensors.

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