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Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial.

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain. mamartinez@unav.es. IdiSNA (Instituto de Investigación Sanitaria de Navarra), Pamplona, Spain. mamartinez@unav.es. Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain. mamartinez@unav.es. Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA. mamartinez@unav.es. Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain. Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain. IdiSNA (Instituto de Investigación Sanitaria de Navarra), Pamplona, Spain. Department of Internal Medicine, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain. Department of Preventive Medicine, University of Malaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain. Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Division of Preventive Medicine, Deparment of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Lipid Clinic, Department of Endocrinology and Nutrition, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clinic,, University of Barcelona, Barcelona, Spain. Osakidetza Basque Health Service, Bioaraba Health Research Institute, Araba University Hospital, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Spain. Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain. Centre for Fertility and Health, Norwegian Institute of Public Health, Oslo, Norway. Blanquerna School of Health Sciences, Universitat Ramon Llull, Barcelona, Spain. Department of Preventive Medicine, University of Valencia, Valencia, Spain. Platform for Clinical Trials, Instituto de Investigación Sanitaria Illes Balears (IdISBa), Hospital Universitario Son Espases, Palma de Mallorca, Spain. Research Unit, Department of Family Medicine, Distrito Sanitario Atención Primaria Sevilla, Sevilla, Spain. Nutrition Research Group, Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain. Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain. Universitat Rovira i Virgili, Departament de Bioquimica i Biotecnologia, Unitat de Nutrició Humana (Grup ANUT-DSM). Institut d'Investigació Sanitària Pere Virgili, Reus, Spain. Departament de Bioquímica i Biotecnologia, Unitat de Nutrició Humana, Universitat Rovira i Virgili, Reus, Spain. Cuerpo Académico UDG-CA-454 Alimentación y Nutrición en el Proceso de Salud-enfermedad, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Mexico. Centro de Investigacion Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.

Cardiovascular diabetology. 2023;(1):262
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Abstract

BACKGROUND Several large observational prospective studies have reported a protection by the traditional Mediterranean diet against type 2 diabetes, but none of them used yearly repeated measures of dietary intake. Repeated measurements of dietary intake are able to improve subject classification and to increase the quality of the assessed relationships in nutritional epidemiology. Beyond observational studies, randomized trials provide stronger causal evidence. In the context of a randomized trial of primary cardiovascular prevention, we assessed type 2 diabetes incidence according to yearly repeated measures of compliance with a nutritional intervention based on the traditional Mediterranean diet. METHODS PREDIMED (''PREvención con DIeta MEDiterránea'') was a Spanish trial including 7447 men and women at high cardiovascular risk. We assessed 3541 participants initially free of diabetes and originally randomized to 1 of 3 diets: low-fat diet (n = 1147, control group), Mediterranean diet supplemented with extra virgin olive (n = 1154) or Mediterranean diet supplemented with mixed nuts (n = 1240). As exposure we used actual adherence to Mediterranean diet (cumulative average), yearly assessed with the Mediterranean Diet Adherence Screener (scoring 0 to 14 points), and repeated up to 8 times (baseline and 7 consecutive follow-up years). This score was categorized into four groups: < 8, 8-< 10, 10- < 12, and 12-14 points. The outcome was new-onset type 2 diabetes. RESULTS Multivariable-adjusted hazard ratios from time-varying Cox models were 0.80 (95% confidence interval, 0.70-0.92) per + 2 points in Mediterranean Diet Adherence Screener (linear trend p = .001), and 0.46 (0.25-0.83) for the highest (12-14 points) versus the lowest (< 8) adherence. This inverse association was maintained after additionally adjusting for the randomized arm. Age- and sex-adjusted analysis of a validated plasma metabolomic signature of the Mediterranean Diet Adherence Screener (constituted of 67 metabolites) in a subset of 889 participants also supported these results. CONCLUSIONS Dietary intervention trials should quantify actual dietary adherence throughout the trial period to enhance the benefits and to assist results interpretation. A rapid dietary assessment tool, yearly repeated as a screener, was able to capture a strong inverse linear relationship between Mediterranean diet and type 2 diabetes. Trial registration ISRCTN35739639.

Methodological quality

Publication Type : Randomized Controlled Trial

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