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Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease (SARCO-HD)

Multi-Omic Biomarkers of Response to an Integrated Intervention (Home-Based Multicomponent Exercise Plus Creatine and/or Beta-Hydroxy-Beta-Methylbutyrate [HMB] Supplementation) to Reduce Sarcopenia and Preserve Muscle and Functional Capacity in Huntington's Disease: A Randomized, Double-Blind, Placebo-Controlled, Four-Arm Trial

Sponsor
Universidad de Burgos (Academic or other)
Enrollment
88 planned
Conditions
Huntington Disease; Sarcopenia; Frailty
Interventions
Creatine monohydrate; Beta-hydroxy-beta-methylbutyrate (HMB); Placebo (microcrystalline cellulose); Home-based multicomponent exercise program
Ages
adults, older adults
Registry
NCT07902206

Full record on ClinicalTrials.gov

From the registry

Huntington's disease (HD) is a rare neurodegenerative disorder in which accelerated loss of muscle mass, strength and autonomy (physical frailty and sarcopenia) contributes to functional decline. This randomized, double-blind, placebo-controlled, four-arm parallel trial will include adults with HD and physical frailty/sarcopenia. All participants will follow a 12-week individualized, home-based multicomponent exercise program (VIVIFRAIL-based, with weekly remote monitoring) and will be randomized 1:1:1:1 to placebo, creatine (CRE), beta-hydroxy-beta-methylbutyrate (HMB) or combined CRE+HMB. The study will test whether combined CRE+HMB produces synergistic improvements in functional capacity, neuromuscular performance, body composition, cognition and quality of life, and will use multi-omic profiling (circulating and extracellular-vesicle microRNAs, plasma proteomics and genetics) to identify mechanisms and predictive signatures of response. Durability of effects will be assessed 6 months after the end of the intervention.

Primary outcomes

  • Change in Total Functional Capacity (TFC)

History

  1. Primary completion expected

  2. Expected to start

  3. Registered