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

doi:10.2337/dc18-0836

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

Jordi Salas-Salvadó¹,² ⇑,
Andrés Díaz-López¹,²,
Miguel Ruiz-Canela²,³,
Josep Basora¹,²,⁴,
Montse Fitó²,⁵,
Dolores Corella²,⁶,
Luís Serra-Majem²,⁷,
Julia Wärnberg²,⁸,
Dora Romaguera²,⁹,
Ramon Estruch²,¹⁰,
Josep Vidal¹¹,¹²,¹³,
J. Alfredo Martínez²,¹⁴,¹⁵,
Fernando Arós²,¹⁶,
Clotilde Vázquez²,¹⁷,
Emilio Ros²,¹⁸,
Jesús Vioque¹⁹,²⁰,
José López-Miranda²,²¹,
Aurora Bueno-Cavanillas²⁰,²²,
Josep A. Tur²,²³,
Francisco J. Tinahones²,²⁴,
Vicente Martín²⁰,²⁵,²⁶,
José Lapetra²,²⁷,
Xavier Pintó²,²⁸,
Lidia Daimiel²⁹,
Miguel Delgado-Rodríguez²⁰,³⁰,
Pilar Matía³¹,
Enrique Gómez-Gracia²,³²,
Javier Díez-Espino²,³,³³,
Nancy Babio¹,²,
Olga Castañer²,⁵,
José V. Sorlí²,⁶,
Miquel Fiol²,⁹,
María Ángeles Zulet²,¹⁴,
Mònica Bulló¹,²,
Albert Goday²,⁵,³⁴ and
Miguel Á. Martínez-González²,³,³⁵ ⇑,
for the PREDIMED-Plus investigators*

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
²Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain
³Department of Preventive Medicine and Public Health, University of Navarra, Navarra Institute for Health Research (IdiSNA), Pamplona, Spain
⁴Primary Care Division, Catalan Institute of Health, Institut d’Investigació i Recerca en Atenció Primària (IDIAP)-Jordi Gol, Barcelona, Spain
⁵Cardiovascular Risk and Nutrition Research Group, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain
⁶Department of Preventive Medicine, University of Valencia, Valencia, Spain
⁷Research Institute of Biomedical and Health Sciences, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain
⁸Department of Nursing, School of Health Sciences, University of Malaga-Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain
⁹Instituto de Investigación Sanitaria Illes Balears (IdISBa), University Hospital of Son Espases, Palma de Mallorca, Spain
¹⁰Department of Internal Medicine, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain
¹¹Endocrinology and Nutrition Department, Hospital Clinic Universitari, Barcelona, Spain
¹²Institut d’Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Barcelona, Spain
¹³Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, Madrid, Spain
¹⁴Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, Pamplona, Spain
¹⁵Madrid Institute for Advanced Studies (IMDEA) Food Institute, Madrid, Spain
¹⁶Department of Cardiology, University Hospital Araba, Vitoria, Spain
¹⁷Department of Endocrinology and Nutrition, University Hospital Fundación Jiménez Díaz, Madrid, Spain
¹⁸Lipid Clinic, Endocrinology and Nutrition Service, Institut d’Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic, University of Barcelona, Barcelona, Spain
¹⁹Nutritional Epidemiology Unit, University of Miguel Hernández, Isabial-Fisabio, Alicante, Spain
²⁰Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain
²¹Lipids and Atherosclerosis Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain
²²Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain
²³Research Group on Community Nutrition and Oxidative Stress, University of the Balearic Islands, Palma de Mallorca, Spain
²⁴Department of Endocrinology and Nutrition, Virgen de la Victoria Hospital, University of Malaga-Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain
²⁵Research Group on Gene-Environment Interactions and Health, University of León, León, Spain
²⁶Biomedicine Institute (IBIOMED), University of León, León, Spain
²⁷Department of Family Medicine, Research Unit, Distrito Sanitario Atención Primaria Sevilla, Sevilla, Spain
²⁸Lipid Unit, Department of Internal Medicine, Bellvitge Biomedical Research Institute (IDIBELL)-Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain
²⁹Nutritional Genomics and Epigenomics Group, Madrid Institute for Advanced Studies (IMDEA) Food Institute, Campus of International Excellence UAM+CSIC, Madrid, Spain
³⁰Department of Health Sciences, University of Jaén, Jaén, Spain
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
³²Department of Preventive Medicine and Public Health, University of Malaga, Malaga, Spain
³³Atención Primaria, Servicio Navarro de Salud–Osasunbidea, Pamplona, Spain
³⁴Department of Medicine, University of Barcelona, Barcelona, Spain
³⁵Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts

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

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, HbA_1c, 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.

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