Abstract
BACKGROUND: Although nutritional supplementation and exercise have shown independent efficacy in managing sarcopenia, data supporting their combined implementation in real-world clinical settings remain limited. METHODS: This 12-week multicenter randomized controlled trial enrolled 110 older adults (≥ 65 years) with sarcopenia or possible sarcopenia. Participants were randomly allocated (1:1) to either the intervention group (n = 55) or control group (n = 55). In addition to their habitual diets, the intervention group received daily muscle-targeted oral nutritional supplementation (MT-ONS, 2 × 10 g sachets/day: containing 8.4 g protein, 0.5 g calcium β-hydroxy-β-methylbutyrate, 200 IU D3 per sachet) alongside a structured exercise programs featuring twice-weekly resistance training (20 min/session), alternate-day chair-based exercises (10 min/session), and home-based activity recommendations. Control group participants maintained their habitual dietary and physical activity patterns without intervention. All outcome measures were assessed at baseline and post-intervention. RESULTS: The intervention group showed modest increases in BIA-derived appendicular lean tissue (mean change + 0.60 kg, 95% CI 0.33 to 0.88), skeletal muscle index (+ 0.20 kg/m², 95% CI 0.11 to 0.29), and handgrip strength (+ 2.22 kg, 95% CI 1.35 to 3.09) compared with the control group. Improvements were also observed in walking speed, chair-stand performance, Short Physical Performance Battery scores, serum vitamin D, and EQ-5D measures of quality of life. CONCLUSION: A 12-week combined intervention of multi-ingredient nutritional supplementation and exercise led to modest improvements in proxy measures of muscle mass, strength, function, and quality of life in older adults. As muscle mass was not directly measured and the study did not employ a factorial design, the relative contributions of exercise and supplementation cannot be determined. These findings suggest that combined interventions may help attenuate, rather than reverse, sarcopenia-related decline. TRIAL REGISTRATION: This clinical trial was registered on Chinese Clinical Trial Registry (ChiCTR2300077187) on 1 November 2023.