Jordi Salas-Salvadó, MD, PhD *; Mònica Bulló, PhD; Ramón Estruch, MD, PhD; Emilio Ros, MD, PhD; Maria-Isabel Covas, DPharm; Núria Ibarrola-Jurado, RD, PhD; Dolores Corella, DPharm, PhD; Fernando Arós, MD, PhD; Enrique Gómez-Gracia, MD, PhD; Valentina Ruiz-Gutiérrez, PhD; Dora Romaguera, MD, PhD; José Lapetra, MD, PhD; Rosa Maria Lamuela-Raventós, DPharm, PhD; Lluís Serra-Majem, MD, PhD; Xavier Pintó, MD, PhD; Josep Basora, MD, PhD; Miguel Angel Muñoz, MD, PhD; José V. Sorlí, MD, PhD; Miguel A. Martínez-González, MD, PhD *
Grant Support: By the official funding agency for biomedical research of the Spanish government, Instituto de Salud Carlos III, through grants provided to research networks specifically developed for the trial (RTIC G03/140 to Dr. Estruch; RTIC RD 06/0045 to Dr. Martínez-González) and through Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición and by grants from Centro Nacional de Investigaciones Cardiovasculares (CNIC 06/2007), Fondo de Investigación Sanitaria–Fondo Europeo de Desarrollo Regional (PI04-2239, PI 05/2584, CP06/00100, PI07/0240, PI07/1138, PI07/0954, PI 07/0473, PI10/01407, PI10/02658, PI11/01647, and P11/02505), Ministerio de Ciencia e Innovación (AGL-2009-13906-C02, AGL2010-22319-C03, and AGL2011-23430), Fundación Mapfre 2010, Consejería de Salud de la Junta de Andalucía (PI0105/2007), Public Health Division of the Department of Health of the Autonomous Government of Catalonia, Generalitat Valenciana (ACOMP06109, GVACOMP2010-181, GVACOMP2011-151, ACOMP2012-190, ACOMP2013-159, ACOMP2013-165, CS2010-AP-111), Agencia Canaria de Investigación, Innovación y Sociedad de la Información-EU FEDER (PI 2007/050 and CS2011-AP-042), and Regional Government of Navarra (P27/2011). The Fundación Patrimonio Comunal Olivarero and Hojiblanca (Malaga, Spain), California Walnut Commission (Sacramento, California), Borges (Reus, Spain), and Morella Nuts (Reus, Spain) donated the olive oil, walnuts, almonds, and hazelnuts, respectively, used in the study.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-1725.
Reproducible Research Statement: Study protocol: Available from Dr. Salas-Salvadó (e-mail, jordi.salas@urv.cat). Statistical code and data set: Not available.
Requests for Single Reprints: Jordi Salas-Salvadó, MD, PhD, Human Nutrition Unit, Faculty of Medicine and Healthy Sciences, Universitat Rovira i Virgili, C/ Sant Llorenç, 21, 43201 Reus, Spain; e-mail, jordi.salas@urv.cat.
Current Author Addresses: Drs. Salas-Salvadó, Bulló, and Ibarrola-Jurado: Human Nutrition Unit, Faculty of Medicine and Healthy Sciences, Universitat Rovira i Virgili, C/ Sant Llorenç, 21, 43201 Reus, Spain.
Dr. Estruch: Department of Internal Medicine, Institut d’Investigacions Biomèdiques August Pi i Sunyer, Hospital Clinic, University of Barcelona, Barcelona, C/ Villarroel, 170, 08036 Barcelona, Spain.
Dr. Ros: Lipid Clinic, Department of Endocrinology and Nutrition, Institut d’Investigacions Biomèdiques August Pi i Sunyer, Hospital Clinic, Barcelona, C/ Villarroel, 170, 08036 Barcelona, Spain.
Dr. Covas: Cardiovascular and Nutrition Research Group, Institut de Recerca Hospital del Mar, Barcelona, C/ Doctor Aiguader, 88, 08003 Barcelona, Spain.
Dr. Corella: Genetic and Molecular Epidemiology Unit, School of Medicine, Department of Preventive Medicine, University of Valencia, Avda Blasco Ibañez, 15, 46010 Valencia, Spain.
Dr. Arós: Department of Cardiology, University Hospital of Alava, C/ Jose Atxotegi, S/N 01009 Vitoria-Gasteiz, Spain.
Dr. Gómez-Gracia: Department of Preventive Medicine, Faculty of Medicine, University of Malaga, Bulevard Luis Pastor, 32, 29071 Malaga, Spain.
Dr. Ruiz-Gutiérrez: Profesora de Investigación del Consejo Superior de Investigaciones Cientíificas, Nutrition and Lipids Metabolism, Instituto de la Grasa, Avenida Padre García Tejero, 4, 41012 Sevilla, Spain.
Dr. Romaguera: Research Unit, University Hospital Son Espases, Balearic Islands, Spain and School of Public Health, Carretera de Valldemossa, 79, 07120 Palma de Mallorca, Illes Balears, Spain.
Dr. Lapetra: Department of Family Medicine, Primary Care Division of Seville, San Pablo Health Center, Sevilla, Jerusalem, S/N 41007 Sevilla, Spain.
Dr. Lamuela-Raventos: Department of Nutrition and Food Science, School of Pharmacy, University of Barcelona, Barcelona, Avinguda de Joan XXIII, 31, 08028 Barcelona, Spain.
Dr. Serra-Majem: Department of Clinical Sciences, University of Las Palmas de Gran Canaria, Edificio Ciencias de la Salud, Campus de San Cristóbal, 35016 Las Palmas de Gran Canaria, Spain.
Dr. Pintó: Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Avd. Feixa Llarga, S/N, 08907 L’Hospitalet de Llobregat, Barcelona, Spain.
Dr. Basora: Primary Care Division, Catalan Institute of Health, Institut d’Investigació en Atenció Primària Jordi Gol, Tarragona-Reus, Universitat Rovira i Virgili, C/ Sant Llorenç, 21, 43201 Reus, Spain.
Dr. Muñoz: Primary Care Division, Catalan Institute of Health, Institut d’Investigació en Atenció Primària Jordi Gol, Barcelona, C/ Sardenya 375, Entlo, 08025 Barcelona, Spain.
Dr. Sorlíi: Primary Care Division, Valencia Institute of Health, Valencia, Faculty of Medicine, Av Vicente Blasco Ibáñez, 26, 46010 Valencia, Spain.
Dr. Martíinez-González: Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Navarra, C/ Irunlarrea 1, 31008, Pamplona, Spain.
Author Contributions: Conception and design: J. Salas-Salvadó, E. Ros, R. Estruch, M.I. Covas, D. Corella, V. Ruiz-Gutiérrez, J. Lapetra, R.M. Lamuela-Raventos, L. Serra-Majem, M.A. Martíinez-González.
Analysis and interpretation of the data: J. Salas-Salvadó, M. Bulló, R. Estruch, E. Ros, M.I. Covas, N. Ibarrola-Jurado, F. Arós, R.M. Lamuela-Raventos, L. Serra-Majem, M.A. Muñoz, M.A. Martíinez-González.
Drafting of the article: J. Salas-Salvadó, M.A. Martíinez-González.
Critical revision of the article for important intellectual content: J. Salas-Salvadó, M. Bulló, R. Estruch, E. Ros, N. Ibarrola-Jurado, D. Corella, E. Gómez-Gracia, V. Ruiz-Gutiérrez, D. Romaguera, J. Lapetra, R.M. Lamuela-Raventos, L. Serra-Majem, X. Pintó, J. Basora, M.A. Muñoz, M.A. Martíinez-González.
Final approval of the article: J. Salas-Salvadó, M. Bulló, E. Ros, M.I. Covas, N. Ibarrola-Jurado, R. Estruch, D. Corella, F. Arós, E. Gómez-Gracia, V. Ruiz-Gutiérrez, J. Lapetra, R.M. Lamuela-Raventos, L. Serra-Majem, X. Pintó, J. Basora, M.A. Muñoz, M.A. Martíinez-González.
Provision of study materials or patients: J. Salas-Salvadó, R. Estruch, D. Corella, E. Gómez-Gracia, J. Lapetra, L. Serra-Majem, X. Pintó, J. Basora, M.A. Muñoz, J.V. Sorlíi, M.A. Martíinez-González.
Statistical expertise: J. Salas-Salvadó, N. Ibarrola-Jurado, D. Corella, M.A. Martíinez-González.
Obtaining of funding: J. Salas-Salvadó, M. Bulló, R. Estruch, E. Ros, D. Corella, F. Arós, E. Gómez-Gracia, V. Ruiz-Gutiérrez, J. Lapetra, M.A. Martíinez-González.
Administrative, technical, or logistic support: J. Salas-Salvadó, N. Ibarrola-Jurado, R. Estruch, E. Gómez-Gracia, J. Lapetra, L. Serra-Majem, X. Pintó, J. Basora, M.A. Martíinez-González.
Collection and assembly of data: J. Salas-Salvadó, M. Bulló, R. Estruch, N. Ibarrola-Jurado, D. Corella, F. Arós, E. Gómez-Gracia, J. Lapetra, L. Serra-Majem, X. Pintó, J. Basora, M.A. Muñoz, J.V. Sorlíi, M.A. Martíinez-González.
This article has been corrected. The original version (PDF) is appended to this article as a Supplement.
Interventions promoting weight loss can reduce the incidence of type 2 diabetes mellitus. Whether dietary changes without calorie restriction also protect from diabetes has not been evaluated.
To assess the efficacy of Mediterranean diets for the primary prevention of diabetes in the Prevención con Dieta Mediterránea trial, from October 2003 to December 2010 (median follow-up, 4.1 years).
Subgroup analysis of a multicenter, randomized trial. (Current Controlled Trials: ISRCTN35739639)
Primary care centers in Spain.
Men and women without diabetes (3541 patients aged 55 to 80 years) at high cardiovascular risk.
Participants were randomly assigned and stratified by site, sex, and age but not diabetes status to receive 1 of 3 diets: Mediterranean diet supplemented with extra-virgin olive oil (EVOO), Mediterranean diet supplemented with nuts, or a control diet (advice on a low-fat diet). No intervention to increase physical activity or lose weight was included.
Incidence of new-onset type 2 diabetes mellitus (prespecified secondary outcome).
During follow-up, 80, 92, and 101 new-onset cases of diabetes occurred in the Mediterranean diet supplemented with EVOO, Mediterranean diet supplemented with mixed nuts, and control diet groups, respectively, corresponding to rates of 16.0, 18.7, and 23.6 cases per 1000 person-years. Multivariate-adjusted hazard ratios were 0.60 (95% CI, 0.43 to 0.85) for the Mediterranean diet supplemented with EVOO and 0.82 (CI, 0.61 to 1.10) for the Mediterranean diet supplemented with nuts compared with the control diet.
Randomization was not stratified by diabetes status. Withdrawals were greater in the control group.
A Mediterranean diet enriched with EVOO but without energy restrictions reduced diabetes risk among persons with high cardiovascular risk.
Instituto de Salud Carlos III.
Salas-Salvadó J, Bulló M, Estruch R, Ros E, Covas M, Ibarrola-Jurado N, et al. Prevention of Diabetes With Mediterranean Diets: A Subgroup Analysis of a Randomized Trial. Ann Intern Med. 2014;160:1–10. doi: 10.7326/M13-1725
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© 2019
Published: Ann Intern Med. 2014;160(1):1-10.
DOI: 10.7326/M13-1725
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism, Prevention/Screening.