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

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 a...

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Autores: Martínez-González, Miguel A, Montero, Pedro, Ruiz-Canela, Miguel, Toledo, Estefanía, Estruch, Ramón, Gómez-Gracia, Enrique, Li, Jun, Ros, Emilio, Arós, Fernando, Hernáez, Alvaro, Corella, Dolores, Fiol Sala, Miquel, Lapetra, José, Serra-Majem, Lluis, Pintó, Xavier, Cofán, Montse, Sorli, Jose V, Babio, Nancy, Márquez-Sandoval, Yolanda F, Castañer, Olga, Salas-Salvado, Jordi
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/23808
Acceso en línea:https://hdl.handle.net/20.500.12105/23808
Access Level:acceso abierto
Palabra clave:Dieta Mediterránea
Incidencia
Factores de Riesgo
Humanos
Estudios Prospectivos
Diabetes Mellitus Tipo 2
Femenino
Enfermedades Cardiovasculares
Aceite de Oliva
Masculino
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Male
Prospective Studies
Female
Risk Factors
Diet, Mediterranean
Humans
Olive Oil
Incidence
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spelling Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trialMartínez-González, Miguel AMontero, PedroRuiz-Canela, MiguelToledo, EstefaníaEstruch, RamónGómez-Gracia, EnriqueLi, JunRos, EmilioArós, FernandoHernáez, AlvaroCorella, DoloresFiol Sala, MiquelLapetra, JoséSerra-Majem, LluisPintó, XavierCofán, MontseSorli, Jose VBabio, NancyMárquez-Sandoval, Yolanda FCastañer, OlgaSalas-Salvado, JordiDieta MediterráneaIncidenciaFactores de RiesgoHumanosEstudios ProspectivosDiabetes Mellitus Tipo 2FemeninoEnfermedades CardiovascularesAceite de OlivaMasculinoDiabetes Mellitus, Type 2Cardiovascular DiseasesMaleProspective StudiesFemaleRisk FactorsDiet, MediterraneanHumansOlive OilIncidenceBackground: 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.BioMed Central (BMC)20242024-10-0920232023-09-2920232023-09-29research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articlehttps://hdl.handle.net/20.500.12105/23808reponame:Repisaludinstname:Instituto de Salud Carlos III (ISCIII)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Atribución 4.0 Internacionalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repisalud.isciii.es:20.500.12105/238082026-06-12T12:43:37Z
dc.title.none.fl_str_mv Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial
title Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial
spellingShingle Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial
Martínez-González, Miguel A
Dieta Mediterránea
Incidencia
Factores de Riesgo
Humanos
Estudios Prospectivos
Diabetes Mellitus Tipo 2
Femenino
Enfermedades Cardiovasculares
Aceite de Oliva
Masculino
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Male
Prospective Studies
Female
Risk Factors
Diet, Mediterranean
Humans
Olive Oil
Incidence
title_short Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial
title_full Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial
title_fullStr Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial
title_full_unstemmed Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial
title_sort Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial
dc.creator.none.fl_str_mv Martínez-González, Miguel A
Montero, Pedro
Ruiz-Canela, Miguel
Toledo, Estefanía
Estruch, Ramón
Gómez-Gracia, Enrique
Li, Jun
Ros, Emilio
Arós, Fernando
Hernáez, Alvaro
Corella, Dolores
Fiol Sala, Miquel
Lapetra, José
Serra-Majem, Lluis
Pintó, Xavier
Cofán, Montse
Sorli, Jose V
Babio, Nancy
Márquez-Sandoval, Yolanda F
Castañer, Olga
Salas-Salvado, Jordi
author Martínez-González, Miguel A
author_facet Martínez-González, Miguel A
Montero, Pedro
Ruiz-Canela, Miguel
Toledo, Estefanía
Estruch, Ramón
Gómez-Gracia, Enrique
Li, Jun
Ros, Emilio
Arós, Fernando
Hernáez, Alvaro
Corella, Dolores
Fiol Sala, Miquel
Lapetra, José
Serra-Majem, Lluis
Pintó, Xavier
Cofán, Montse
Sorli, Jose V
Babio, Nancy
Márquez-Sandoval, Yolanda F
Castañer, Olga
Salas-Salvado, Jordi
author_role author
author2 Montero, Pedro
Ruiz-Canela, Miguel
Toledo, Estefanía
Estruch, Ramón
Gómez-Gracia, Enrique
Li, Jun
Ros, Emilio
Arós, Fernando
Hernáez, Alvaro
Corella, Dolores
Fiol Sala, Miquel
Lapetra, José
Serra-Majem, Lluis
Pintó, Xavier
Cofán, Montse
Sorli, Jose V
Babio, Nancy
Márquez-Sandoval, Yolanda F
Castañer, Olga
Salas-Salvado, Jordi
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Dieta Mediterránea
Incidencia
Factores de Riesgo
Humanos
Estudios Prospectivos
Diabetes Mellitus Tipo 2
Femenino
Enfermedades Cardiovasculares
Aceite de Oliva
Masculino
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Male
Prospective Studies
Female
Risk Factors
Diet, Mediterranean
Humans
Olive Oil
Incidence
topic Dieta Mediterránea
Incidencia
Factores de Riesgo
Humanos
Estudios Prospectivos
Diabetes Mellitus Tipo 2
Femenino
Enfermedades Cardiovasculares
Aceite de Oliva
Masculino
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Male
Prospective Studies
Female
Risk Factors
Diet, Mediterranean
Humans
Olive Oil
Incidence
description 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.
publishDate 2023
dc.date.none.fl_str_mv 2023
2023-09-29
2023
2023-09-29
2024
2024-10-09
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.12105/23808
url https://hdl.handle.net/20.500.12105/23808
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Atribución 4.0 Internacional
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Atribución 4.0 Internacional
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BioMed Central (BMC)
publisher.none.fl_str_mv BioMed Central (BMC)
dc.source.none.fl_str_mv reponame:Repisalud
instname:Instituto de Salud Carlos III (ISCIII)
instname_str Instituto de Salud Carlos III (ISCIII)
reponame_str Repisalud
collection Repisalud
repository.name.fl_str_mv
repository.mail.fl_str_mv
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