Effects of β-hydroxy-β-methylbutyrate (HMB) supplementation in addition to multicomponent exercise in adults older than 70 years living in nursing homes, a cluster randomized placebo-controlled trial: the HEAL study protocol

BMC Geriatr. 2019 Jul 5;19(1):188. doi: 10.1186/s12877-019-1200-5.


Background: Evidence supports the fact that multicomponent exercise and HMB supplementation are, separately, effective in improving older adult's health and palliate functional metabolic diseases in older people. However, the true effect of HMB supplementation combined with a tailored exercise program in frail older adults is still unknown. Thus, the aim of the HEAL (HMB + Exercise = Adults Living longer) study is to assess the effects of the combination of a daily multicomponent exercise and resistance training (VIVIFRAIL program) intervention in addition to HMB supplementation on older adults' health.

Methods/design: A 24-week cluster randomized, double-blind, placebo-controlled study will be conducted on 104 adults ≥70 years. Nursing homes will be randomized to either of four groups: Ex-HMB (exercise intervention with HMB), Ex-Plac (exercise intervention with placebo), NoEx-HMB (no exercise intervention with HMB), and Controls (No exercise and no HMB). Intervention groups which include exercise will complete the individualized multicomponent (strength, balance and cardiovascular exercises) training program VIVIFRAIL. Intervention groups which include HMB supplementation will receive a 3 g/daily dose of free acid HMB in powder form. The primary outcome measure is the functional capacity. Secondary outcome measures are muscle strength and power, frailty and fall risk, body composition, biochemical analyses and cardiometabolic risk factor, disability and comorbidity, cognitive function and depression.

Discussion: The findings of the HEAL study will help professionals from public health systems to identify cost-effective and innovative actions to improve older people's health and quality of life, and endorse exercise practice in older adults and people living in nursing homes.

Trial registration: NCT03827499 ; Date of registration: 01/02/2019.

Keywords: Dynapenia; Falls; Healthy ageing; Physical activity; Physical fitness.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cluster Analysis
  • Combined Modality Therapy
  • Dietary Supplements*
  • Double-Blind Method
  • Exercise / physiology*
  • Exercise / psychology*
  • Exercise Therapy / methods
  • Female
  • Frail Elderly / psychology
  • Homes for the Aged / trends*
  • Humans
  • Male
  • Muscle Strength / physiology
  • Nursing Homes / trends*
  • Quality of Life / psychology
  • Resistance Training / methods
  • Resistance Training / trends
  • Treatment Outcome
  • Valerates / administration & dosage*


  • Valerates
  • beta-hydroxyisovaleric acid

Associated data

  • ClinicalTrials.gov/NCT03827499