IMPROVING REHABILITATION IN SARCOPENIA (IRIS) BY MUSCLE-TARGETED NUTRITIONAL SUPPORT: A DOUBLE-BLIND RCT

Abstract

We evaluated the efficacy of a muscle-targeted nutritional support on the outcome of a physical exercise rehabilitation program in old adults with sarcopenia. A double-blind RCT (NCT03120026) in sarcopenic old adults (65 years) without severe cognitive impairment and admitted to an in-patient rehabilitation facility for a physical rehabilitation program. In addition to a standard hospital diet, patients (n=140) were randomized to receive until discharge (for at least 4 weeks and up to 8 weeks) a whey protein-based nutritional supplement enriched with leucine and vitamin D or an iso-caloric placebo twice daily. The primary efficacy endpoint was the change in 4-meter gait speed per month. Key secondary endpoints were change in physical performance outcome measures: chair-stand test, Timed up and go test, Short Physical Performance Battery. The overall economic benefits (surrogates: length of stay; duration of rehabilitation) were also evaluated. Intention-to-treat analyses were based on patients re-assessed at discharge (n=127). Supplementation with the experimental formula (n=64) resulted in greater increase in gait speed than placebo (n=63): mean difference, 0.063 meters/sec/month [95%CI, 0.043 to 0.082] (P<0.001). A significant effect was also found for all physical performance, functional and cognitive function endpoints (P<0.001 for all) and body composition. Supplementation resulted also in in shorter rehabilitation (P<0.001) and hospital stay (p<0.001). 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, muscle mass and reduced the intensity and costs of care.