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

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• dc.contributor.author Martínez-González, Miguel Ángel, 1957-
• dc.contributor.author Hernáez, Álvaro
• dc.contributor.author Castañer, Olga
• dc.contributor.author Salas Salvadó, Jordi
• dc.date.accessioned 2024-05-02T05:49:42Z
• dc.date.available 2024-05-02T05:49:42Z
• dc.date.issued 2023
• dc.description.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.
• dc.description.sponsorship Primary Funding Source Instituto de Salud Carlos III. The PREDIMED trial was supported by Instituto de Salud Carlos III (ISCIII), the official funding agency for biomedical research of the Spanish government, through grants provided to research networks specifically developed for the trial (RTIC G03/140, to Ramón Estruch during 2003–2005; RTIC RD 06/0045, to Miguel A. Martínez-González during 2006–2013 and through Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición [CIBEROBN]), 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, P11/02505, PI13/00462, and JR17/00022), Ministerio de Ciencia e Innovación (AGL-2009–13906-C02, AGL2010- 22319-C03, AGL2011-23430, and SAF2016–80532-R), Fundación Mapfre 2010 (no role in the design, implementation, analysis or interpretation of the data), 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 (PROMETEO 17/2017, and PROMETEO 21/2021), Fundació La Marató-TV3 (grants 294/C/2015 and 538/U/2016 (no role in the design, implementation, analysis or interpretation of the data)), 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 metabolomic study was supported by research grant NIDDK-R01DK 102896 from the National Institutes of Health. Donations of olive oil, walnuts, almonds, and hazelnuts were made respectively by the Fundación Patrimonio Comunal Olivarero and Hojiblanca (Malaga, Spain), California Walnut Commission (Sacramento, California), Borges (Reus, Spain), and Morella Nuts (Reus, Spain). Prof. Jordi Salas-Salvadó is partially supported by ICREA, under the ICREA Academia programme.
• dc.format.mimetype application/pdf
• dc.identifier.citation Martínez-González MA, Montero P, Ruiz-Canela M, Toledo E, Estruch R, Gómez-Gracia E, et al. Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial. Cardiovasc Diabetol. 2023 Sep 29;22(1):262. DOI: 10.1186/s12933-023-01994-2
• dc.identifier.doi http://dx.doi.org/10.1186/s12933-023-01994-2
• dc.identifier.issn 1475-2840
• dc.identifier.uri http://hdl.handle.net/10230/59962
• dc.language.iso eng
• dc.publisher BioMed Central
• dc.relation.ispartof Cardiovasc Diabetol. 2023 Sep 29;22(1):262
• dc.relation.projectID info:eu-repo/grantAgreement/ES/3PN/AGL2009–13906-C02
• dc.relation.projectID info:eu-repo/grantAgreement/ES/3PN/AGL2010-22319-C03
• dc.relation.projectID info:eu-repo/grantAgreement/ES/3PN/AGL2011-23430
• dc.relation.projectID info:eu-repo/grantAgreement/ES/1PE/SAF2016–80532-R
• dc.rights © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Diabetes
• dc.subject.keyword Dietary assessment tools
• dc.subject.keyword Feeding trial
• dc.subject.keyword Monounsaturated fats
• dc.subject.keyword Nutritional epidemiology
• dc.subject.keyword Olive oil
• dc.title Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion