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Title: Mediterranean diets and metabolic syndrome status in the PREDIMED randomized trial
Authors: Babio, Nancy
Toledo, Estefanía
Estruch, Ramón
Ros, Emilio
Martínez-González, Miguel A.
Castañer, Olga
Bulló, Mònica
Corella, Dolores
Arós, Fernando
Gómez-Gracia, Enrique
Ruiz-Gutiérrez, Valentina
Fiol, Miquel
Lapetra, José
Lamuela-Raventos, Rosa M.
Serra-Majem, Lluís 
Pintó, Xavier
Basora, Josep
Sorlí, José V.
Salas-Salvadó, Jordi
Keywords: Cardiovascular Risk-Factors
Body-Fat Distribution
Monounsaturated Fat
Spanish Men, et al
Issue Date: 2014
Publisher: 0820-3946
Journal: CMAJ 
Abstract: Background: 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.Methods: 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).Results: 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 meta-bolic 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 0.921.27, 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.Interpretation: 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. Trial registration:, no. ISRCTN35739639.
ISSN: 0820-3946
DOI: 10.1503/cmaj.140764
Source: CMAJ[ISSN 0820-3946],v. 186, p. E649-E657
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