Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial
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 classifi...
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| Format: | Article |
| Language: | English |
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BMC
2023-09-01
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| Series: | Cardiovascular Diabetology |
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| Online Access: | https://doi.org/10.1186/s12933-023-01994-2 |
| _version_ | 1797454004528087040 |
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| author | Miguel A. Martínez-González Pedro Montero Miguel Ruiz-Canela Estefanía Toledo Ramón Estruch Enrique Gómez-Gracia Jun Li Emilio Ros Fernando Arós Alvaro Hernáez Dolores Corella Miquel Fiol José Lapetra Lluis Serra-Majem Xavier Pintó Montse Cofán José V. Sorlí Nancy Babio Yolanda F. Márquez-Sandoval Olga Castañer Jordi Salas-Salvadó |
| author_facet | Miguel A. Martínez-González Pedro Montero Miguel Ruiz-Canela Estefanía Toledo Ramón Estruch Enrique Gómez-Gracia Jun Li Emilio Ros Fernando Arós Alvaro Hernáez Dolores Corella Miquel Fiol José Lapetra Lluis Serra-Majem Xavier Pintó Montse Cofán José V. Sorlí Nancy Babio Yolanda F. Márquez-Sandoval Olga Castañer Jordi Salas-Salvadó |
| author_sort | Miguel A. Martínez-González |
| collection | DOAJ |
| 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 |
| first_indexed | 2024-03-09T15:30:59Z |
| format | Article |
| id | doaj.art-3324fd4a2fc44ede9e3a5934fb279422 |
| institution | Directory Open Access Journal |
| issn | 1475-2840 |
| language | English |
| last_indexed | 2024-03-09T15:30:59Z |
| publishDate | 2023-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Cardiovascular Diabetology |
| spelling | doaj.art-3324fd4a2fc44ede9e3a5934fb2794222023-11-26T12:15:53ZengBMCCardiovascular Diabetology1475-28402023-09-0122111110.1186/s12933-023-01994-2Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trialMiguel A. Martínez-González0Pedro Montero1Miguel Ruiz-Canela2Estefanía Toledo3Ramón Estruch4Enrique Gómez-Gracia5Jun Li6Emilio Ros7Fernando Arós8Alvaro Hernáez9Dolores Corella10Miquel Fiol11José Lapetra12Lluis Serra-Majem13Xavier Pintó14Montse Cofán15José V. Sorlí16Nancy Babio17Yolanda F. Márquez-Sandoval18Olga Castañer19Jordi Salas-Salvadó20Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Department of Preventive Medicine and Public Health, University of NavarraInstituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Department of Preventive Medicine, University of Malaga, Instituto de Investigación Biomédica de Málaga (IBIMA)Department of Nutrition, Harvard T.H. Chan School of Public HealthInstituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Lipid Clinic, Department of Endocrinology and Nutrition, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clinic,, University of BarcelonaInstituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)Cuerpo Académico UDG-CA-454 Alimentación y Nutrición en el Proceso de Salud-enfermedad, Centro Universitario de Ciencias de la Salud, Universidad de GuadalajaraUnit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar d’Investigacions Mèdiques (IMIM)Instituto de Salud Carlos III, Centro de Investigacion Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERObn)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 ISRCTN35739639https://doi.org/10.1186/s12933-023-01994-2DiabetesFeeding trialNutritional epidemiologyOlive oilMonounsaturated fatsDietary assessment tools |
| spellingShingle | Miguel A. Martínez-González Pedro Montero Miguel Ruiz-Canela Estefanía Toledo Ramón Estruch Enrique Gómez-Gracia Jun Li Emilio Ros Fernando Arós Alvaro Hernáez Dolores Corella Miquel Fiol José Lapetra Lluis Serra-Majem Xavier Pintó Montse Cofán José V. Sorlí Nancy Babio Yolanda F. Márquez-Sandoval Olga Castañer Jordi Salas-Salvadó Yearly attained adherence to Mediterranean diet and incidence of diabetes in a large randomized trial Cardiovascular Diabetology Diabetes Feeding trial Nutritional epidemiology Olive oil Monounsaturated fats Dietary assessment tools |
| title | 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_short | 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 |
| topic | Diabetes Feeding trial Nutritional epidemiology Olive oil Monounsaturated fats Dietary assessment tools |
| url | https://doi.org/10.1186/s12933-023-01994-2 |
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