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Randomized Controlled Trial
. 2023 Oct 2;6(10):e2337994.
doi: 10.1001/jamanetworkopen.2023.37994.

An Energy-Reduced Mediterranean Diet, Physical Activity, and Body Composition: An Interim Subgroup Analysis of the PREDIMED-Plus Randomized Clinical Trial

Jadwiga Konieczna  1   2 , Miguel Ruiz-Canela  2   3 , Aina M Galmes-Panades  2   4 , Itziar Abete  2   5 , Nancy Babio  2   6   7 , Miquel Fiol  1   2 , Vicente Martín-Sánchez  8   9 , Ramón Estruch  2   10   11 , Josep Vidal  12   13 , Pilar Buil-Cosiales  2   3   14 , Jesús F García-Gavilán  2   6   7 , Manuel Moñino  1   2 , Alba Marcos-Delgado  9 , Rosa Casas  2   10   11 , Romina Olbeyra  13 , Montserrat Fitó  2   15 , Frank B Hu  16   17 , Miguel Ángel Martínez-Gonzalez  2   3   17 , J Alfredo Martínez  2   5   18 , Dora Romaguera  1   2 , Jordi Salas-Salvadó  2   6   7
Affiliations
Randomized Controlled Trial

An Energy-Reduced Mediterranean Diet, Physical Activity, and Body Composition: An Interim Subgroup Analysis of the PREDIMED-Plus Randomized Clinical Trial

Jadwiga Konieczna et al. JAMA Netw Open. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Estruch reported receiving olive oil for trials from Patrimonio Comunal Olivarero, Spain, and walnuts for trials from the California Walnut Commission during the conduct of the study; nonfinancial support for research from the Fundación Bosch I Gimpera; fees from Brewers of Europe for organizing a European conference; personal fees from the Fundación Cerveza y Salud and the Fundacion Dieta Mediterranea for educational conferences; grants from FIVIN for a trial on wine and health; personal fees from Pernaud Richart for educational conferences; nonfinancial support from Karolinska Institute, Menarini Laboratories for the International Symposium on Cardiovascular Risk, Stockholm for nonfinancial support from Italian Pavilion, for the EXPO DUBAI 2020 Congress on Mediterranean Diet; nonfinancial support for attendance from Cretan Lifestyle: Mediterranean Tradition & Modern Applications Congress in Creta; nonfinancial support from the Empowering Consumers: FoP labeling Reform: Health, Knowledge, Liberties European Parliament; nonfinancial support from the Pontifical Academy of Sciences, the Art & Science of Olive Oil: Nutrition, Medicine and Planetary Health: Securing the Future of a World Cultural Heritage meeting; grants from Grand-Fountain Laboratories for a clinical trial; and personal fees from Dallant Laboratories, Spain Technical Consultations outside the submitted work. Dr Salas-Salvadó reported receiving personal fees from Instituto Danone Spain Member as a member of the advisory board, fees or travel expenses for meeting attendant from Danone Institute International and International Nut and Dried Fruit Foundation; and grants from the International Nut and Dried Fruit Foundation grant to his institution; and is an unpaid member of the advisory board outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Adjusted Means of Body Composition Parameters Through Follow-Up by Study Arm
The primary trial outcomes of fat mass (A), lean mass (B), and visceral mass (C) were calculated in participants who completed the study. Percentages of fat mass and lean mass were calculated in relation to dual energy x-ray absorptiometry–derived total body mass (sum of total bone, fat, and muscle mass). Means were minimally adjusted for center, cluster family, and individualized participant. Error bars indicate 95% CIs.
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