NCT07902206Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 20 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Universidad de Burgos
- Diseases
- Huntington's disease
- NCT number
- NCT07902206
What you commit to
- Study type: Interventional
- Planned participants: 88
- From 1 Nov 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of protein supplements in the month before inclusion.
Other illness
- 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.
Other
- Severe dysphagia preventing safe intake of thickened liquids (unless a clinically acceptable alternative exists).
- Pregnancy or lactation.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.