An Energy-Reduced Mediterranean Diet, Physical Activity, and Body Composition: An Interim Subgroup Analysis of the PREDIMED-Plus Randomized Clinical 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
| Outcome | Estimate | |
|---|---|---|
| Body composition · 1 yearInterventionvs Control | between group difference, % total fat −0.94 % (95% CI −1.19 to −0.69) | |
| Body composition · 1 yearInterventionvs Control | between group difference, % total lean mass 0.88 % (95% CI 0.63%–1.12%) | |
| −1.5−1−0.500.511.5Difference, % (linear scale) |
| Outcome | Between group difference, visceral fat (g) (95% CI) | |
|---|---|---|
| Body composition · 1 yearInterventionvs Control | −126 (−179 to −73.3) | |
| −200−1000100Difference, g (linear scale) |
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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