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

Trial details

Who runs it

Universidad de Burgos

Trial code

NCT07902206

Record updated

2026. október 28.

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Age 18 years or older with genetically confirmed Huntington's disease (HD) (cytosine-adenine-guanine [CAG] repeat expansion in the huntingtin [HTT] gene); Symptomatic HD, defined by a Unified Huntington's Disease Rating Scale (UHDRS) total motor score > 4, in early-intermediate stages according to Total Functional Capacity (TFC); Physical frailty and/or sarcopenia, defined as Short Physical Performance Battery (SPPB) score <= 10 and/or gait speed < 1.0 m/s and/or European Working Group on Sarcopenia in Older People 2 (EWGSOP2) sarcopenia criteria (low strength and low muscle quantity/quality assessed by validated bioelectrical impedance analysis (BIA)-derived indices); VIVIFRAIL category B (frail) or C1/C2 (pre-frail); Stable pharmacological treatment for at least 4 weeks before baseline; Clinical judgement of the neurologist and occupational therapist that the participant can safely perform a prescribed home-based exercise program with weekly remote monitoring; Written informed consent from the participant or legally authorized representative (with participant assent whenever possible).

Exclusion: Use of protein supplements in the month before inclusion; Unstable cardiovascular, renal, hepatic or musculoskeletal disease contraindicating exercise or supplementation; Severe chorea or postural instability preventing safe training; uncontrolled psychiatric symptoms or active substance abuse; Allergy or intolerance to any supplement component; Severe dysphagia preventing safe intake of thickened liquids (unless a clinically acceptable alternative exists); Pregnancy or lactation.

ClinicalTrials.gov NCT07902206