An energy-reduced mediterranean diet, physical activity, and body composition: An interim subgroup analysis of the PREDIMED-Plus randomized clinical trial

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  • dc.contributor.author Konieczna, Jadwiga
  • dc.contributor.author Fitó Colomer, Montserrat
  • dc.contributor.author Salas Salvadó, Jordi
  • dc.date.accessioned 2024-05-21T06:24:12Z
  • dc.date.available 2024-05-21T06:24:12Z
  • dc.date.issued 2023
  • dc.description.abstract Importance: Strategies targeting body composition may help prevent chronic diseases in persons with excess weight, but randomized clinical trials evaluating lifestyle interventions have rarely reported effects on directly quantified body composition. Objective: To evaluate the effects of a lifestyle weight-loss intervention on changes in overall and regional body composition. Design, setting, and participants: The ongoing Prevención con Dieta Mediterránea-Plus (PREDIMED-Plus) randomized clinical trial is designed to test the effect of the intervention on cardiovascular disease prevention after 8 years of follow-up. The trial is being conducted in 23 Spanish research centers and includes men and women (age 55-75 years) with body mass index between 27 and 40 and metabolic syndrome. The trial reported herein is an interim subgroup analysis of the intermediate outcome body composition after 3-year follow-up, and data analysis was conducted from February 1 to November 30, 2022. Of 6874 total PREDIMED-Plus participants, a subsample of 1521 individuals, coming from centers with access to a dual energy x-ray absorptiometry device, underwent body composition measurements at 3 time points. Intervention: Participants were randomly allocated to a multifactorial intervention based on an energy-reduced Mediterranean diet (MedDiet) and increased physical activity (PA) or to a control group based on usual care, with advice to follow an ad libitum MedDiet, but no physical activity promotion. Main outcomes and measures: The outcomes (continuous) were 3-year changes in total fat and lean mass (expressed as percentages of body mass) and visceral fat (in grams), tested using multivariable linear mixed-effects models. Clinical relevance of changes in body components (dichotomous) was assessed based on 5% or more improvements in baseline values, using logistic regression. Main analyses were performed in the evaluable population (completers only) and in sensitivity analyses, multiple imputation was performed to include data of participants lost to follow-up (intention-to-treat analyses). Results: A total of 1521 individuals were included (mean [SD] age, 65.3 [5.0] years; 52.1% men). In comparison with the control group (n=761), participants in the intervention arm (n=760) showed greater reductions in the percentage of total fat (between group differences after 1-year, -0.94% [95% CI, -1.19 to -0.69]; 3 years, -0.38% [95% CI, -0.64 to -0.12] and visceral fat storage after 1 year, -126 g [95% CI, -179 to -73.3 g]; 3 years, -70.4 g [95% CI, -126 to -15.2 g] and greater increases in the percentage of total lean mass at 1 year, 0.88% [95% CI, 0.63%-1.12%]; 3-years 0.34% [95% CI, 0.09%-0.60%]). The intervention group was more likely to show improvements of 5% or more in baseline body components (absolute risk reduction after 1 year, 13% for total fat mass, 11% for total lean mass, and 14% for visceral fat mass; after 3-years: 6% for total fat mass, 6% for total lean mass, and 8% for visceral fat mass). The number of participants needed to treat was between 12 and 17 to attain at least 1 individual with possibly clinically meaningful improvements in body composition. Conclusions and relevance: The findings of this trial suggest a weight-loss lifestyle intervention based on an energy-reduced MedDiet and physical activity significantly reduced total and visceral fat and attenuated age-related losses of lean mass in older adults with overweight or obesity and metabolic syndrome. Continued follow-up is warranted to confirm the long-term consequences of these changes on cardiovascular clinical end points. Trial registration: isrctn.org Identifier: ISRCTN89898870.
  • dc.description.sponsorship This work was supported by NIH grant 1R01DK127601to (M.R.C., F.B.H., and J.S.S), the European Research Council advanced research grant 2014-2019; agreement 340918 (M.AM.G.), and the official Spanish Institutions for funding scientific biomedical research, CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN) and Instituto de Salud Carlos III (ISCIII), through the Fondo de Investigación para la Salud (FIS), which is cofunded by the European Regional Development Fund (6 coordinated FIS projects led by J.V. and J.S.S., including the following projects: PI13/00673, PI13/00492, PI13/00272, PI13/01123, PI13/00462, PI13/00233, PI13/02184, PI13/00728, PI13/01090, PI13/01056, PI14/01722, PI14/00636, PI14/00618, PI14/00696, PI14/01206, PI14/01919, PI14/00853, PI14/01374, PI14/00972, PI14/00728, PI14/01471, PI16/00473, PI16/00662, PI16/01873, PI16/01094, PI16/00501, PI16/00533, PI16/00381, PI16/00366, PI16/01522, PI16/01120, PI17/00764, PI17/01183, PI17/00855, PI17/01347, PI17/00525, PI17/01827, PI17/00532, PI17/00215, PI17/01441, PI17/00508, PI17/01732, PI17/00926, PI19/00957, PI19/00386, PI19/00309, PI19/01032, PI19/00576, PI19/00017, PI19/01226, PI19/00781, PI19/01560, PI19/01332, PI20/01802, PI20/00138, PI20/01532, PI20/00456, PI20/00339, PI20/00557, PI20/00886, PI20/01158); the Especial Action Project entitled: Implementación y evaluación de una intervención intensiva sobre la actividad física Cohorte PREDIMED-Plus grant (J.S.S.); the Recercaixa grant (2013ACUP00194) (J.S.S.); grants from the Consejería de Salud de la Junta de Andalucía (PI0458/2013, PS0358/2016, PI0137/2018); the PROMETEO/2017/017 grant from the Generalitat Valenciana; the SEMERGEN grant; INSA-Ma María de Maeztu Unit of Excellence (grant CEX2021-001234-M funded by MICIN/AEI/FEDER, UE); Juan de la Cierva Research Grant (IJC2019-042420-I / AEI / 10.13039/501100011033) from Agencia Estatal de Investigación to J.K., and a contract financed by the Government of the Balearic Islands Funds to A.M.G.P. This work was also partially supported by ICREA under the ICREA Academia program.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Konieczna J, Ruiz-Canela M, Galmes-Panades AM, Abete I, Babio N, Fiol M, et al. An energy-reduced mediterranean diet, physical activity, and body composition: An interim subgroup analysis of the PREDIMED-Plus randomized clinical trial. JAMA Netw Open. 2023 Oct 2;6(10):e2337994. DOI: 10.1001/jamanetworkopen.2023.37994
  • dc.identifier.doi http://dx.doi.org/10.1001/jamanetworkopen.2023.37994
  • dc.identifier.issn 2574-3805
  • dc.identifier.uri http://hdl.handle.net/10230/60194
  • dc.language.iso eng
  • dc.publisher American Medical Association
  • dc.relation.ispartof JAMA Netw Open. 2023 Oct 2;6(10):e2337994
  • dc.relation.projectID info:eu-repo/grantAgreement/EC/FP7/340918
  • dc.rights © 2023 Konieczna J et al. JAMA Network Open. This is an open access article distributed under the terms of the CC-BY License (http://creativecommons.org/licenses/by/4.0/).
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by/4.0/
  • dc.subject.other Malalties cròniques--Tractament
  • dc.subject.other Dieta mediterrània
  • dc.title An energy-reduced mediterranean diet, physical activity, and body composition: An interim subgroup analysis of the PREDIMED-Plus randomized clinical trial
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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