Effect of vitamin D, omega-3 supplementation, or a home exercise program on muscle mass and sarcopenia: DO-HEALTH trial

Background: We aimed to investigate the effect of daily supplemental vitamin D, omega-3s, and a thrice-weekly home exercise program, alone or in combination, on change of appendicular lean muscle mass index (ALMI) and incident sarcopenia in older adults. Methods: This is a secondary endpoint analysis of a 3-year randomized, double-blind, placebo-controlled trial with a 2 × 2 × 2 factorial design among 2157 community-dwelling, healthy adults aged 70 + years, from 2012 to 2018 (DO-HEALTH). Participants were randomized to 2000 IU/d vitamin D and/or 1 g/d marine omega-3s and/or exercise. Change in ALMI over 3 years was calculated in all participants who underwent dual energy X-ray absorptiometry (DXA) (n = 1495) using mixed effect models. Incident sarcopenia was analyzed based on the Sarcopenia Definitions and Outcomes Consortium in all non-sarcopenic participants (n = 1940). Results: Among 1495 participants (mean age 74.9 (sd 4.4); 63.3% were women; 80.5% were at least moderately physically active at baseline) mean gait speed at baseline was 1.2 m/s (sd 0.3), mean ALMI at baseline was 6.65 (SD 0.95) in women, and 8.01 (SD 0.88) kg/m in men. At year 3, average change of ALMI was -0.09 (sd 0.34) kg/m (-1.35%) in women and - 0.17 (sd 0.33) kg/m (-2.0%) in men. None of the treatments individually or in combination had a benefit on ALMI change compared to control over 3 years, with omega-3s showing a small protective effect on ALMI at year 1 only (-0.021 vs. no-omega-3s -0.066 kg/m, p = 0.001). Of 1940 non-sarcopenic participants at baseline, 88 (4.5%) developed incident sarcopenia over 3 years. None of the treatments individually or in combination reduced the odds of incident sarcopenia compared with placebo. Conclusion: Among healthy, physically active older adults, ALMI and incidence of sarcopenia were not improved by treatment of daily 2000 IU vitamin D, daily 1 g omega-3s, or a simple home exercise program compared with control over 3 years.