Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial.
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Salas-Salvadó Jordi, Díaz-López Andrés, Ruiz-Canela Miguel, Basora Josep, Fitó Montse, Corella Dolores, Serra-Majem Luís, Wärnberg Julia, Romaguera Dora, Estruch Ramon, Vidal Josep, Martínez J Alfredo, Arós Fernando, Vázquez Clotilde, Ros Emilio, Vioque Jesús, López-Miranda José, Bueno-Cavanillas Aurora, Tur Josep A, Tinahones Francisco J, Martín Vicente, Lapetra José, Pintó Xavier, Daimiel Lidia, Delgado-Rodríguez Miguel, Matía Pilar, Gómez-Gracia Enrique, Díez-Espino Javier, Babio Nancy, Castañer Olga, Sorlí José V, Fiol Miquel, Zulet María Ángeles, Bulló Mònica, Goday Albert, Martínez-González Miguel Á, PREDIMED-Plus investigators
Аннотация
RESEARCH DESIGN AND METHODS: Overweight/obese adults with metabolic syndrome aged 55-75 years (n = 626) were randomized to an intensive weight loss lifestyle intervention based on an energy-restricted Mediterranean diet, physical activity promotion, and behavioral support (IG) or a control group (CG). The primary and secondary outcomes were changes in weight and cardiovascular risk markers, respectively.
RESULTS: Diet and physical activity changes were in the expected direction, with significant improvements in IG versus CG. After 12 months, IG participants lost an average of 3.2 kg vs. 0.7 kg in the CG (P < 0.001), a mean difference of -2.5 kg (95% CI -3.1 to -1.9). Weight loss ≥5% occurred in 33.7% of IG participants compared with 11.9% in the CG (P < 0.001). Compared with the CG, cardiovascular risk factors, including waist circumference, fasting glucose, triglycerides, and HDL cholesterol, significantly improved in IG participants (P < 0.002). Reductions in insulin resistance, HbA1c, and circulating levels of leptin, interleukin-18, and MCP-1 were greater in IG than CG participants (P < 0.05). IG participants with prediabetes/diabetes significantly improved glycemic control and insulin sensitivity, along with triglycerides and HDL cholesterol levels compared with their CG counterparts.
CONCLUSIONS: PREDIMED-Plus intensive lifestyle intervention for 12 months was effective in decreasing adiposity and improving cardiovascular risk factors in overweight/obese older adults with metabolic syndrome, as well as in individuals with or at risk for diabetes.