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Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Sponsor: Universidad de Burgos
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2026-11
Completion Date
2028-12
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Creatine monohydrate
3 g/day creatine monohydrate (with 3 g microcrystalline cellulose when given alone, or with 3 g beta-hydroxy-beta-methylbutyrate (HMB) in the combined arm), dissolved in 100 mL fruit juice and taken once daily with the evening meal for 12 weeks, in identical coded sachets.
Beta-hydroxy-beta-methylbutyrate (HMB)
3 g/day HMB (with 3 g microcrystalline cellulose when given alone, or with 3 g creatine monohydrate in the combined arm), dissolved in 100 mL fruit juice and taken once daily with the evening meal for 12 weeks, in identical coded sachets.
Placebo (microcrystalline cellulose)
6 g/day microcrystalline cellulose, suspended in 100 mL fruit juice and taken once daily with the evening meal for 12 weeks, in sachets identical in appearance to the active supplements.
Home-based multicomponent exercise program
12-week individualized home-based multicomponent exercise program (strength, balance, gait and endurance) based on VIVIFRAIL, adapted to Huntington's disease (HD)-specific motor and cognitive limitations, prescribed and supervised by an occupational therapist, with weekly training logs and phone calls to monitor adherence, perceived exertion (target Borg rating of perceived exertion \[RPE\] 12-15) and adverse events. All participants also receive Mediterranean-style dietary advice (protein 1.2-1.5 g/kg/day).
Locations (1)
Hospital Universitario de Burgos
Burgos, Castille and León, Spain