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Original Research
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
Jordi Salas-Salvadó, Andrés Díaz-López, Miguel Ruiz-Canela, Josep Basora, Montse Fitó, Dolores Corella, Luís Serra-Majem, Julia Wärnberg, Dora Romaguera, Ramon Estruch, Josep Vidal, J. Alfredo Martínez, Fernando Arós, Clotilde Vázquez, Emilio Ros, Jesús Vioque, José López-Miranda, Aurora Bueno-Cavanillas, Josep A. Tur, Francisco J. Tinahones, Vicente Martín, José Lapetra, Xavier Pintó, Lidia Daimiel, Miguel Delgado-Rodríguez, Pilar Matía, Enrique Gómez-Gracia, Javier Díez-Espino, Nancy Babio, Olga Castañer, José V. Sorlí, Miquel Fiol, María Ángeles Zulet, Mònica Bulló, Albert Goday, Miguel A. Martínez-González, for the PREDIMED-Plus investigators
Diabetes Care 2018 Nov; dc180836. https://doi.org/10.2337/dc18-0836
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Abstract

OBJECTIVE The long-term impact of intentional weight loss on cardiovascular events remains unknown. We describe 12-month changes in body weight and cardiovascular risk factors in PREvención con DIeta MEDiterránea (PREDIMED)-Plus, a trial designed to evaluate the long-term effectiveness of an intensive weight-loss lifestyle intervention on primary cardiovascular prevention.

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.

Footnotes

  • This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc18-0836/-/DC1.

  • ↵* A complete list of the PREDIMED-Plus investigators can be found in the Supplementary Data.

  • Received April 17, 2018.
  • Accepted September 29, 2018.
  • © 2018 by the American Diabetes Association.
http://www.diabetesjournals.org/content/license

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.

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Diabetes Care: 44 (4)

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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
Jordi Salas-Salvadó, Andrés Díaz-López, Miguel Ruiz-Canela, Josep Basora, Montse Fitó, Dolores Corella, Luís Serra-Majem, Julia Wärnberg, Dora Romaguera, Ramon Estruch, Josep Vidal, J. Alfredo Martínez, Fernando Arós, Clotilde Vázquez, Emilio Ros, Jesús Vioque, José López-Miranda, Aurora Bueno-Cavanillas, Josep A. Tur, Francisco J. Tinahones, Vicente Martín, José Lapetra, Xavier Pintó, Lidia Daimiel, Miguel Delgado-Rodríguez, Pilar Matía, Enrique Gómez-Gracia, Javier Díez-Espino, Nancy Babio, Olga Castañer, José V. Sorlí, Miquel Fiol, María Ángeles Zulet, Mònica Bulló, Albert Goday, Miguel A. Martínez-González, for the PREDIMED-Plus investigators
Diabetes Care Nov 2018, dc180836; DOI: 10.2337/dc18-0836

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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
Jordi Salas-Salvadó, Andrés Díaz-López, Miguel Ruiz-Canela, Josep Basora, Montse Fitó, Dolores Corella, Luís Serra-Majem, Julia Wärnberg, Dora Romaguera, Ramon Estruch, Josep Vidal, J. Alfredo Martínez, Fernando Arós, Clotilde Vázquez, Emilio Ros, Jesús Vioque, José López-Miranda, Aurora Bueno-Cavanillas, Josep A. Tur, Francisco J. Tinahones, Vicente Martín, José Lapetra, Xavier Pintó, Lidia Daimiel, Miguel Delgado-Rodríguez, Pilar Matía, Enrique Gómez-Gracia, Javier Díez-Espino, Nancy Babio, Olga Castañer, José V. Sorlí, Miquel Fiol, María Ángeles Zulet, Mònica Bulló, Albert Goday, Miguel A. Martínez-González, for the PREDIMED-Plus investigators
Diabetes Care Nov 2018, dc180836; DOI: 10.2337/dc18-0836
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© 2021 by the American Diabetes Association. Diabetes Care Print ISSN: 0149-5992, Online ISSN: 1935-5548.