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


Journal

Cardiovascular diabetology
ISSN: 1475-2840
Titre abrégé: Cardiovasc Diabetol
Pays: England
ID NLM: 101147637

Informations de publication

Date de publication:
29 09 2023
Historique:
received: 24 07 2023
accepted: 15 09 2023
medline: 2 10 2023
pubmed: 30 9 2023
entrez: 29 9 2023
Statut: epublish

Résumé

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. 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. 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. 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.

Sections du résumé

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.

Identifiants

pubmed: 37775736
doi: 10.1186/s12933-023-01994-2
pii: 10.1186/s12933-023-01994-2
pmc: PMC10542699
doi:

Substances chimiques

Olive Oil 0

Banques de données

ISRCTN
['ISRCTN35739639']

Types de publication

Randomized Controlled Trial Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

262

Subventions

Organisme : NIDDK NIH HHS
ID : R01 DK102896
Pays : United States

Informations de copyright

© 2023. BioMed Central Ltd., part of Springer Nature.

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Auteurs

Miguel A Martínez-González (MA)

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.

Pedro Montero (P)

Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.

Miguel Ruiz-Canela (M)

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 Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.

Estefanía Toledo (E)

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 Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.

Ramón Estruch (R)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain.
Department of Internal Medicine, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain.

Enrique Gómez-Gracia (E)

Department of Preventive Medicine, University of Malaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.

Jun Li (J)

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.

Emilio Ros (E)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain.
Lipid Clinic, Department of Endocrinology and Nutrition, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clinic,, University of Barcelona, Barcelona, Spain.

Fernando Arós (F)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain.
Osakidetza Basque Health Service, Bioaraba Health Research Institute, Araba University Hospital, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Spain.

Alvaro Hernáez (A)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, 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.

Dolores Corella (D)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain.
Department of Preventive Medicine, University of Valencia, Valencia, Spain.

Miquel Fiol (M)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain.
Platform for Clinical Trials, Instituto de Investigación Sanitaria Illes Balears (IdISBa), Hospital Universitario Son Espases, Palma de Mallorca, Spain.

José Lapetra (J)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain.
Research Unit, Department of Family Medicine, Distrito Sanitario Atención Primaria Sevilla, Sevilla, Spain.

Lluis Serra-Majem (L)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, 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.

Xavier Pintó (X)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain.
Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain.

Montse Cofán (M)

Lipid Clinic, Department of Endocrinology and Nutrition, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clinic,, University of Barcelona, Barcelona, Spain.

José V Sorlí (JV)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain.
Department of Preventive Medicine, University of Valencia, Valencia, Spain.

Nancy Babio (N)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, 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.

Yolanda F Márquez-Sandoval (YF)

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.

Olga Castañer (O)

Unit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.
Centro de Investigacion Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.

Jordi Salas-Salvadó (J)

Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn), Madrid, Spain.
Departament de Bioquímica i Biotecnologia, Unitat de Nutrició Humana, Universitat Rovira i Virgili, Reus, Spain.

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