Effects of resistance training and/or beta-hydroxy-beta-methylbutyrate supplementation on muscle mass, muscle strength and physical performance in older women with reduced muscle mass: protocol for a randomised, double-blind, placebo-controlled trial

INTRODUCTION: Resistance training (RT) and nutritional supplementation seem to have beneficial effects on muscle properties and physical performance in older adults. However, the reported effects of specific RT programmes and supplementation prescriptions vary among studies. The present study aims to examine the acute and residual effects of RT and/or beta-hydroxy-beta-methylbutyrate (HMB) supplementation on muscle mass, muscle strength and physical performance in older women with reduced muscle mass. METHODS AND ANALYSIS: This is a randomised, double-blind, placebo-controlled trial. Older women fitting the eligibility criteria were recruited in February 2018 from a population-based sample identified via screening conducted in October 2017. In March 2018, 156 participants were randomly allocated to undergo one of four interventions (RT + HMB, RT + placebo, education + HMB and education + placebo) for 12 weeks. Supervised RT consisted of body weight, elastic band, ankle weight and machine-based exercises two times per week at the Tokyo Metropolitan Institute of Gerontology (TMIG). Each participant ingested HMB (1200 mg) or placebo supplements once daily. Sessions of education not associated with sarcopenia treatment were conducted every 2 weeks. Post-intervention follow-up will be conducted for 12 weeks, until September 2018. The study includes assessments conducted in March (baseline), June (post-intervention) and September 2018 (follow-up). The primary outcome is the longitudinal change in muscle mass. Secondary outcomes include the longitudinal changes in muscle strength, physical performance, muscle thickness, muscle quality, blood counts, blood biochemistry, calf circumference, skin viscoelasticity, habitual dietary intake, habitual physical activity levels, functional capacity and health-related quality of life. Intention-to-treat analyses will be conducted. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the TMIG, Japan. The study is being conducted according to the principles of the Declaration of Helsinki. The findings will be presented at international academic congresses and published in peer-reviewed international journals. TRIAL REGISTRATION NUMBER: UMIN000028560; Post-results.