Jordi Salas-Salvadó1,2, Andrés Díaz-López3,2, Miguel Ruiz-Canela2,4, Josep Basora3,2,5, Montse Fitó2,6, Dolores Corella2,7, Luís Serra-Majem2,8, Julia Wärnberg2,9, Dora Romaguera2,10, Ramon Estruch2,11, Josep Vidal12,13,14, J Alfredo Martínez2,15,16, Fernando Arós2,17, Clotilde Vázquez2,18, Emilio Ros2,19, Jesús Vioque20,21, José López-Miranda2,22, Aurora Bueno-Cavanillas21,23, Josep A Tur2,24, Francisco J Tinahones2,25, Vicente Martín21,26,27, José Lapetra2,28, Xavier Pintó2,29, Lidia Daimiel30, Miguel Delgado-Rodríguez21,31, Pilar Matía32, Enrique Gómez-Gracia2,33, Javier Díez-Espino2,4,34, Nancy Babio3,2, Olga Castañer2,6, José V Sorlí2,7, Miquel Fiol2,10, María Ángeles Zulet2,15, Mònica Bulló3,2, Albert Goday2,6,35, Miguel Á Martínez-González36,4,37. 1. Department 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 jordi.salas@urv.cat mamartinez@unav.es. 2. Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain. 3. Department 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. 4. Department of Preventive Medicine and Public Health, University of Navarra, Navarra Institute for Health Research (IdiSNA), Pamplona, Spain. 5. Primary Care Division, Catalan Institute of Health, Institut d'Investigació i Recerca en Atenció Primària (IDIAP)-Jordi Gol, Barcelona, Spain. 6. Cardiovascular Risk and Nutrition Research Group, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain. 7. Department of Preventive Medicine, University of Valencia, Valencia, Spain. 8. Research Institute of Biomedical and Health Sciences, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain. 9. Department of Nursing, School of Health Sciences, University of Malaga-Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain. 10. Instituto de Investigación Sanitaria Illes Balears (IdISBa), University Hospital of Son Espases, Palma de Mallorca, Spain. 11. Department of Internal Medicine, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain. 12. Endocrinology and Nutrition Department, Hospital Clinic Universitari, Barcelona, Spain. 13. Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Barcelona, Spain. 14. Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain. 15. Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, Pamplona, Spain. 16. Madrid Institute for Advanced Studies (IMDEA) Food Institute, Madrid, Spain. 17. Department of Cardiology, University Hospital Araba, Vitoria, Spain. 18. Department of Endocrinology and Nutrition, University Hospital Fundación Jiménez Díaz, Madrid, Spain. 19. Lipid Clinic, Endocrinology and Nutrition Service, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic, University of Barcelona, Barcelona, Spain. 20. Nutritional Epidemiology Unit, University of Miguel Hernández, Isabial-Fisabio, Alicante, Spain. 21. Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain. 22. Lipids and Atherosclerosis Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain. 23. Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain. 24. Research Group on Community Nutrition and Oxidative Stress, University of the Balearic Islands, Palma de Mallorca, Spain. 25. Department of Endocrinology and Nutrition, Virgen de la Victoria Hospital, University of Malaga-Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain. 26. Research Group on Gene-Environment Interactions and Health, University of León, León, Spain. 27. Biomedicine Institute (IBIOMED), University of León, León, Spain. 28. Department of Family Medicine, Research Unit, Distrito Sanitario Atención Primaria Sevilla, Sevilla, Spain. 29. Lipid Unit, Department of Internal Medicine, Bellvitge Biomedical Research Institute (IDIBELL)-Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain. 30. Nutritional Genomics and Epigenomics Group, Madrid Institute for Advanced Studies (IMDEA) Food Institute, Campus of International Excellence UAM+CSIC, Madrid, Spain. 31. Department of Health Sciences, University of Jaén, Jaén, Spain. 32. Endocrinology 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. 33. Department of Preventive Medicine and Public Health, University of Malaga, Malaga, Spain. 34. Atención Primaria, Servicio Navarro de Salud-Osasunbidea, Pamplona, Spain. 35. Department of Medicine, University of Barcelona, Barcelona, Spain. 36. Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain jordi.salas@urv.cat mamartinez@unav.es. 37. Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
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.
RCT Entities:
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.
Authors: Carmen Sayón-Orea; Cristina Razquin; Mónica Bulló; Dolores Corella; Montserrat Fitó; Dora Romaguera; Jesús Vioque; Ángel M Alonso-Gómez; Julia Wärnberg; J Alfredo Martínez; Luís Serra-Majem; Ramón Estruch; Francisco J Tinahones; José Lapetra; Xavier Pintó; Josep A Tur; José López-Miranda; Aurora Bueno-Cavanillas; Miguel Delgado-Rodríguez; Pilar Matía-Martín; Lidia Daimiel; Vicente Martín Sánchez; Josep Vidal; Clotilde Vázquez; Emilio Ros; Miguel Ruiz-Canela; José V Sorlí; Olga Castañer; Miquel Fiol; Eva M Navarrete-Muñoz; Fernando Arós; Enrique Gómez-Gracia; M Angeles Zulet; Almudena Sánchez-Villegas; Rosa Casas; Rosa Bernal-López; José M Santos-Lozano; Emili Corbella; Cristina Bouzas; Ana García-Arellano; Josep Basora; Eva M Asensio; Helmut Schröder; Manuel Moñino; Manoli García de la Hera; Lucas Tojal-Sierra; Estefanía Toledo; Andrés Díaz-López; Albert Goday; Jordi Salas-Salvadó; Miguel A Martínez-González Journal: JAMA Date: 2019-10-15 Impact factor: 56.272
Authors: Andrés Díaz-López; Indira Paz-Graniel; Verónica Ruiz; Estefanía Toledo; Nerea Becerra-Tomás; Dolores Corella; Olga Castañer; J Alfredo Martínez; Ángel M Alonso-Gómez; Julia Wärnberg; Jesús Vioque; Dora Romaguera; José López-Miranda; Ramon Estruch; Francisco J Tinahones; José Lapetra; Luís Serra-Majem; Aurora Bueno-Cavanillas; Josep A Tur; Vicente Martín Sánchez; Xavier Pintó; Miguel Delgado-Rodríguez; Pilar Matía-Martín; Josep Vidal; Clotilde Vázquez; Lidia Daimiel; Tania Fernandez Villa; Emilio Ros; Sonia Eguaras; Nancy Babio; Jose V Sorlí; Albert Goday; Itziar Abete; Lucas Tojal Sierra; Francisco Javier Barón-López; Laura Torres-Collado; Marga Morey; Antonio Garcia-Rios; Rosa Casas; María Rosa Bernal-López; José Manuel Santos-Lozano; Adela Navarro; Jose I Gonzalez; María Dolores Zomeño; Maria Angeles Zulet; Jessica Vaquero Luna; Raul Ramallal; Montse Fitó; Jordi Salas-Salvadó Journal: Sci Rep Date: 2021-04-22 Impact factor: 4.379
Authors: Eva-Maria Navarrete-Muñoz; Jesus Vioque; Estefanía Toledo; Alejando Oncina-Canovas; Miguel Ángel Martínez-González; Jordi Salas-Salvadó; Dolores Corella; Montserrat Fitó; Dora Romaguera; Ángel M Alonso-Gómez; Julia Wärnberg; J Alfredo Martínez; Luís Serra-Majem; Ramon Estruch; Francisco J Tinahones; José Lapetra; Xavier Pintó; Josep A Tur; José López-Miranda; Aurora Bueno-Cavanillas; Pilar Matía-Martín; Lidia Daimiel; Vicente Martín Sánchez; Josep Vidal; Ana Isabel de Cos Blanco; Emili Ros; Javier Diez-Espino; Nancy Babio; Rebeca Fernandez-Carrion; Olga Castañer; Antoni Colom; Laura Compañ-Gabucio; Itziar Salaverria Lete; Edelys Crespo-Oliva; Itziar Abete; Laura Tomaino; Rosa Casas; José Carlos Fernandez-Garcia; José Manuel Santos-Lozano; Iziar Sarasa; José M Gámez; José M Antonio Garcia-Rios; Sandra Martín-Pelaez; Miguel Ruiz-Canela; Andrés Díaz-López; Raul Martinez-Lacruz; Maria Dolors Zomeño; Elena Rayó; Cristina Gisbert Sellés; Silvia Canudas; Albert Goday; Manoli García-de-la-Hera Journal: Eur J Nutr Date: 2020-08-24 Impact factor: 5.614
Authors: Nerea Becerra-Tomás; Guillermo Mena-Sánchez; Andrés Díaz-López; Miguel Ángel Martínez-González; Nancy Babio; Dolores Corella; Gala Freixer; Dora Romaguera; Jesús Vioque; Ángel M Alonso-Gómez; Julia Wärnberg; J Alfredo Martínez; Lluís Serra-Majem; Ramon Estruch; José Carlos Fernández-García; José Lapetra; Xavier Pintó; Josep A Tur; José López-Miranda; Aurora Bueno-Cavanillas; José Juan Gaforio; Pilar Matía-Martín; Lidia Daimiel; Vicente Martín-Sánchez; Josep Vidal; Clotilde Vázquez; Emili Ros; Cristina Razquin; Iván Abellán Cano; Jose V Sorli; Laura Torres; Marga Morey; Eva Mª Navarrete-Muñoz; Lucas Tojal Sierra; Edelys Crespo-Oliva; M Ángeles Zulet; Almudena Sanchez-Villegas; Rosa Casas; M Rosa Bernal-Lopez; José Manuel Santos-Lozano; Emili Corbella; Maria Del Mar Bibiloni; Miguel Ruiz-Canela; Rebeca Fernández-Carrión; Mireia Quifer; Rafel M Prieto; Noelia Fernandez-Brufal; Itziar Salaverria Lete; Juan Carlos Cenoz; Regina Llimona; Jordi Salas-Salvadó Journal: Eur J Nutr Date: 2019-08-05 Impact factor: 5.614