Improving rehabilitation in sarcopenia: a randomized‐controlled trial utilizing a muscle‐targeted food for special medical purposes

Abstract

Background Sarcopenia is a disease associated with aging and a negative prognosis. Consensus-based treatment consists in targeting muscle mass and function through physical exercise, optimization of protein intake, and vitamin D supplementation, but evidence is lacking. We evaluated the safety and efficacy of a muscle-targeted nutritional support on the outcome of a physical exercise rehabilitation programme. Methods In a single-site, double-blind, randomized, controlled trial (NCT03120026; May 2017 to December 2018), old (≥65 years) adults [N = 140 (63% female patients; age, 81 ± 6 years)] without severe cognitive impairment, who were found to have sarcopenia by European Working Group on Sarcopenia in Older People 2010 criteria and hospitalized for physical rehabilitation, were randomized to receive until discharge (for at least 4 weeks and up to 8 weeks) a whey protein-based nutritional formula enriched with leucine and vitamin D or an iso-caloric control formula twice daily in addition to a standard hospital diet. The primary endpoint was the change in 4 m gait speed per month. Key secondary endpoints addressed the change in physical performance: chair-stand test, timed up and go test, and short physical performance battery. Other secondary outcomes were the change in functional status, muscle strength and mass, cognitive status, and quality of life. The proportion of patients who improved their rehabilitation intensity profile and overall economic benefits (using length of stay and duration of rehabilitation as surrogate measures) were also evaluated. Results A total of 161 patients were screened and 140 were randomized to study interventions. Thirteen patients (experimental, n = 6; placebo, n = 7) discontinued the intervention because they disliked the product and intention-to-treat analyses were based on patients reassessed at discharge [n = 127 (66% female patients; age, 81 ± 6 years)]. Supplementation with the experimental formula (n = 64) resulted in greater increase in mean gait speed {0.061 m/s/month [95% confidence interval (CI), 0.043 to 0.080]} than placebo [n = 63; À0.001 m/s/month (95%CI, À0.008 to 0.006)]: mean difference, 0.063 m/s/month (95% CI, 0.043 to 0.082) (P < 0.001). A significant effect was also found for muscle mass (P < 0.03) and all key secondary outcomes, functional and cognitive endpoints (P < 0.001 for all). Supplementation resulted also in higher proportion of patients improving their rehabilitation intensity profile (P = 0.003) and being discharged home (P = 0.002); shorter rehabilitation (P < 0.001); and hospital stay (P < 0.001). Conclusions In old adults with sarcopenia admitted to hospital for rehabilitation the consumption of a whey protein-based nutritional formula enriched with leucine and vitamin D improved physical performance and function, as well as muscle mass, and reduced the intensity and costs of care.

Effects of 12 weeks of Multi-nutrient supplementation on the Immune and Musculoskeletal systems of Older Adults in Aged-Care (The Pomerium Study): Protocol for a Randomised Controlled Trial

“…Various studies indicate that older adults require a daily protein intake of 1.0 to 1.2g / kg body weight to support muscle health and function. 38,81 In well-controlled and powered RCTs of sarcopenic older adults, supplementation using whey protein enhances muscle mass and function 82 83 and prevents mobility impairment. 84 85 Our team recently showed in a 2-year clustered-randomised nutrition intervention involving over 7,000 older adults in aged-care that increased dietary protein (from 0.9 to 1.1g/kg body weight) and calcium intakes were associated with maintenance of appendicular muscle mass.…”

Combating sarcopenia in geriatric rehabilitation patients: study protocol of the EMPOWER-GR observational cohort, sarcopenia awareness survey and randomised controlled feasibility trial

“…The combination of whey protein, leucine and vitamin D in the study product has been shown to stimulate muscle protein synthesis 35–37 and increase muscle mass, as well as lower extremity function in sarcopenic older adults. 31 38 …”

Recovery Focused Nutritional Therapy across the Continuum of Care: Learning from COVID-19

“…By combining an individualised physical rehabilitation programme with a muscle-targeted ONS (20-g whey protein, 2.8-g leucine, 800-IU vitamin D and 500-mg calcium) twice daily for 4–8 weeks, compared to a control group who received an iso-caloric protein-free drink, cost-effective improvements were seen for their physical performance, physical function and muscle mass. In those who received the muscle-targeted supplement, a greater proportion were discharged home instead of to a care facility (+24%), had a reduction in intensity of care at discharge (+22%), needed less rehabilitation (−27% in duration) and had a shorter length of stay (−10 days) [ 61 ].…”