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Continuing Evolution of Nutritional Therapy for Diabetes

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

  1. Jordi Salas-Salvadó1,2⇑,
  2. Andrés Díaz-López1,2,
  3. Miguel Ruiz-Canela2,3,
  4. Josep Basora1,2,4,
  5. Montse Fitó2,5,
  6. Dolores Corella2,6,
  7. Luís Serra-Majem2,7,
  8. Julia Wärnberg2,8,
  9. Dora Romaguera2,9,
  10. Ramon Estruch2,10,
  11. Josep Vidal11,12,13,
  12. J. Alfredo Martínez2,14,15,
  13. Fernando Arós2,16,
  14. Clotilde Vázquez2,17,
  15. Emilio Ros2,18,
  16. Jesús Vioque19,20,
  17. José López-Miranda2,21,
  18. Aurora Bueno-Cavanillas20,22,
  19. Josep A. Tur2,23,
  20. Francisco J. Tinahones2,24,
  21. Vicente Martín20,25,26,
  22. José Lapetra2,27,
  23. Xavier Pintó2,28,
  24. Lidia Daimiel29,
  25. Miguel Delgado-Rodríguez20,30,
  26. Pilar Matía31,
  27. Enrique Gómez-Gracia2,32,
  28. Javier Díez-Espino2,3,33,
  29. Nancy Babio1,2,
  30. Olga Castañer2,5,
  31. José V. Sorlí2,6,
  32. Miquel Fiol2,9,
  33. María Ángeles Zulet2,14,
  34. Mònica Bulló1,2,
  35. Albert Goday2,5,34 and
  36. Miguel Á. Martínez-González2,3,35⇑,
  37. for the PREDIMED-Plus investigators*
  1. 1Department of Biochemistry and Biotechnology, Human Nutrition Unit, Pere Virgili Institute for Health Research (IISPV), University Hospital of Sant Joan de Reus, Rovira i Virgili University, Reus, Spain
  2. 2Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain
  3. 3Department of Preventive Medicine and Public Health, University of Navarra, Navarra Institute for Health Research (IdiSNA), Pamplona, Spain
  4. 4Primary Care Division, Catalan Institute of Health, Institut d’Investigació i Recerca en Atenció Primària (IDIAP)-Jordi Gol, Barcelona, Spain
  5. 5Cardiovascular Risk and Nutrition Research Group, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain
  6. 6Department of Preventive Medicine, University of Valencia, Valencia, Spain
  7. 7Research Institute of Biomedical and Health Sciences, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain
  8. 8Department of Nursing, School of Health Sciences, University of Malaga-Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain
  9. 9Instituto de Investigación Sanitaria Illes Balears (IdISBa), University Hospital of Son Espases, Palma de Mallorca, Spain
  10. 10Department of Internal Medicine, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain
  11. 11Endocrinology and Nutrition Department, Hospital Clinic Universitari, Barcelona, Spain
  12. 12Institut d’Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Barcelona, Spain
  13. 13Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain
  14. 14Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, Pamplona, Spain
  15. 15Madrid Institute for Advanced Studies (IMDEA) Food Institute, Madrid, Spain
  16. 16Department of Cardiology, University Hospital Araba, Vitoria, Spain
  17. 17Department of Endocrinology and Nutrition, University Hospital Fundación Jiménez Díaz, Madrid, Spain
  18. 18Lipid Clinic, Endocrinology and Nutrition Service, Institut d’Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic, University of Barcelona, Barcelona, Spain
  19. 19Nutritional Epidemiology Unit, University of Miguel Hernández, Isabial-Fisabio, Alicante, Spain
  20. 20Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain
  21. 21Lipids and Atherosclerosis Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain
  22. 22Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain
  23. 23Research Group on Community Nutrition and Oxidative Stress, University of the Balearic Islands, Palma de Mallorca, Spain
  24. 24Department of Endocrinology and Nutrition, Virgen de la Victoria Hospital, University of Malaga-Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain
  25. 25Research Group on Gene-Environment Interactions and Health, University of León, León, Spain
  26. 26Biomedicine Institute (IBIOMED), University of León, León, Spain
  27. 27Department of Family Medicine, Research Unit, Distrito Sanitario Atención Primaria Sevilla, Sevilla, Spain
  28. 28Lipid Unit, Department of Internal Medicine, Bellvitge Biomedical Research Institute (IDIBELL)-Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain
  29. 29Nutritional Genomics and Epigenomics Group, Madrid Institute for Advanced Studies (IMDEA) Food Institute, Campus of International Excellence UAM+CSIC, Madrid, Spain
  30. 30Department of Health Sciences, University of Jaén, Jaén, Spain
  31. 31Endocrinology and Nutrition Department, Facultad de Medicina, Hospital Clínico San Carlos-Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Universidad Complutense de Madrid, Madrid, Spain
  32. 32Department of Preventive Medicine and Public Health, University of Malaga, Malaga, Spain
  33. 33Atención Primaria, Servicio Navarro de Salud–Osasunbidea, Pamplona, Spain
  34. 34Department of Medicine, University of Barcelona, Barcelona, Spain
  35. 35Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
  1. Corresponding author: Jordi Salas-Salvadó, jordi.salas{at}urv.cat, or Miguel Á. Martínez-González, mamartinez{at}unav.es
    Diabetes Care 2019 May; 42(5): 777-788. 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

    • Clinical trial reg. no. ISRCTN89898870, www.isrctn.org

    • 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 online.

    • This article is part of a special article collection available at http://care.diabetesjournals.org/evolution-nutritional-therapy.

    • This article is featured in a podcast available at http://www.diabetesjournals.org/content/diabetes-core-update-podcasts.

    • 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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    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 Á. Martínez-González
    Diabetes Care May 2019, 42 (5) 777-788; 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 Á. Martínez-González
    Diabetes Care May 2019, 42 (5) 777-788; DOI: 10.2337/dc18-0836
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