Obesity

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

JAMA Netw OpenPublished Secondary analysis of the PREDIMED-Plus randomised trial

Authors' conclusion

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.

Study context

Population
Men and women aged 55–75 years with BMI 27–40 and metabolic syndrome, from centers with DXA access; mean age 65.3 years, 52.1% menDXA subsample
Participants
1,521 men
Comparison
Energy-reduced Mediterranean diet (MedDiet) plus increased physical activity (PA) vs usual care
  • Interventionn = 760
  • Controln = 761reference
Primary endpoint
Changes in total fat and lean mass (% of body mass) and visceral fat (g)
Follow-up
3 years
Methodological detailsinterim subgroup analysis, multicentre, 23 Spanish research centers, Data analysis February 1 to November 30, 2022
  • Interim subgroup analysis
  • Multicentre
  • 23 Spanish research centers
  • Data analysis February 1 to November 30, 2022

Primary result

As reported in the abstract

Body composition
Each group vs controlEstimate (95% CI)
Intervention
between group difference, % total fat −0.38 %(−0.64 to −0.12)
Intervention
between group difference, % total lean mass 0.34 %(0.09%–0.60%)
Each group vs controlBetween group difference, visceral fat, g (95% CI)
Intervention
−70.4(−126 to −15.2)

Further findings

OutcomeEstimate
Body composition · 1 yearInterventionvs Controlbetween group difference, % total fat −0.94 % (95% CI −1.19 to −0.69)
Body composition · 1 yearInterventionvs Controlbetween group difference, % total lean mass 0.88 % (95% CI 0.63%–1.12%)
OutcomeBetween group difference, visceral fat (g) (95% CI)
Body composition · 1 yearInterventionvs Control−126 (−179 to −73.3)

Improvement ≥5% in baseline body components

Absolute risk reduction at 1 year: total fat / total lean / visceral fat mass
13% / 11% / 14%
Absolute risk reduction at 3 years: total fat / total lean / visceral fat mass
6% / 6% / 8%
NNT for clinically meaningful improvement in body composition
between 12 and 17
  • Intervention more likely to improve

Original publication

An Energy-Reduced Mediterranean Diet, Physical Activity, and Body Composition: An Interim Subgroup Analysis of the PREDIMED-Plus Randomized Clinical Trial. JAMA Netw Open. Published 2 October 2023. doi:10.1001/jamanetworkopen.2023.37994

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