Huntington DiseaseSARCO-HDNCT07902206
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
A study testing Creatine monohydrate, Beta-hydroxy-beta-methylbutyrate (HMB) and Home-based multicomponent exercise program in people with Huntington Disease and Sarcopenia, run by Universidad de Burgos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease, Sarcopenia, Frailty
- What is being tested?
- Creatine monohydrate, Beta-hydroxy-beta-methylbutyrate (HMB) and Home-based multicomponent exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
- Severe dysphagia preventing safe intake of thickened liquids (unless a clinically acceptable alternative exists).
- Allergy or intolerance to any supplement component.
- Pregnancy or lactation.
- Use of protein supplements in the month before inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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 the detailed description
Design: randomized, double-blind, placebo-controlled, four-arm parallel-group trial conducted at the Neurology Department of Hospital Universitario de Burgos (HUBU; recruitment, clinical assessment, biological sampling) and the University of Burgos (UBU; exercise physiology, functional testing and multi-omic analyses).
Randomization: computer-generated permuted blocks of variable size (REDCap), 1:1:1:1 allocation, stratified by sex, antipsychotic use, participation in structured exercise programs and diabetes. Allocation is performed and concealed by an independent pharmacist (HUBU Pharmacy Service). Participants, intervention staff, outcome assessors and data analysts are blinded; supplements are packed in identical coded sachets.
Interventions: once daily for 12 weeks, dissolved in 100 mL fruit juice with the evening meal: (1) 3 g creatine monohydrate + 3 g microcrystalline cellulose; (2) 3 g beta-hydroxy-beta-methylbutyrate (HMB) + 3 g cellulose; (3) 3 g creatine + 3 g HMB; (4) placebo, 6 g microcrystalline cellulose. All participants follow a Mediterranean-style diet (protein 1.2-1.5 g/kg/day) and an individualized home-based multicomponent exercise program based on VIVIFRAIL, prescribed and supervised by an occupational therapist, with weekly phone calls to monitor adherence, perceived exertion (target Borg rating of perceived exertion [RPE] 12-15) and adverse events. Adherence is monitored by intake logs and sachet counts.
Assessments: baseline (T0), week 12 (T1, end of intervention) and 6-month follow-up (T2). Functional capacity (Unified Huntington's Disease Rating Scale [UHDRS] Total Functional Capacity [TFC], Functional Assessment Scale, Independence Scale, gait speed, Short Physical Performance Battery [SPPB]), body composition (multifrequency bioimpedance), neuromuscular function (rate of force development and peak force during isometric knee extension), cognition (Mini-Mental State Examination [MMSE], Symbol Digit Modalities Test [SDMT], Stroop test, Trail Making Test [TMT], verbal fluency), quality of life (12-Item Short Form Health Survey [SF-12]) and adverse events. Fasting blood samples for small RNA sequencing (RNA-seq) of circulating and extracellular-vesicle microRNAs (with quantitative polymerase chain reaction [qPCR] validation), plasma proteomics (Olink Reveal, 1,034 proteins) and pharmacogenetics (15 single nucleotide polymorphisms [SNPs] in SLC6A8, CKM, GATM, MTOR, AKT1, PTEN; genome-wide genotyping in a subset).
Sample size: 64 participants (16 per arm) are needed to detect a small-to-moderate effect (f = 0.20) on change in TFC (alpha 0.05, power 0.80, r = 0.50); allowing for 25-30% dropout, 84-88 participants will be enrolled.
Statistical analysis: intention-to-treat and per-protocol analyses; linear mixed-effects models with Group x Time interaction and pre-specified contrasts of creatine (CRE)+HMB versus each single supplement and placebo; multi-omic integration (mixOmics/DIABLO, MOFA+, elastic net, random forest) with repeated nested cross-validation to identify predictive signatures of response.
- Conditions
- Huntington Disease, Sarcopenia, Frailty
- Being tested
- Creatine monohydrate, Beta-hydroxy-beta-methylbutyrate (HMB), Placebo (microcrystalline cellulose), Home-based multicomponent exercise program
- Keywords
- Creatine, Beta-hydroxy-beta-methylbutyrate (HMB), Multicomponent exercise, microRNA, Extracellular vesicles, Proteomics, Pharmacogenetics, Neuromuscular function
- Medical subject headings
- Huntington Disease, Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDietary supplement
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)Dietary supplement
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)Dietary supplement
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 programBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Exercise | Placebo comparator | Placebo (6 g/day microcrystalline cellulose) for 12 weeks plus the individualized home-based multicomponent exercise program. Receives: Dietary Supplement: Placebo (microcrystalline cellulose); Behavioral: Home-based multicomponent exercise program |
| Creatine + Exercise | Experimental | 3 g/day creatine monohydrate + 3 g/day microcrystalline cellulose for 12 weeks plus the individualized home-based multicomponent exercise program. Receives: Dietary Supplement: Creatine monohydrate; Behavioral: Home-based multicomponent exercise program |
| Beta-Hydroxy-Beta-Methylbutyrate (HMB) + Exercise | Experimental | 3 g/day beta-hydroxy-beta-methylbutyrate (HMB) + 3 g/day microcrystalline cellulose for 12 weeks plus the individualized home-based multicomponent exercise program. Receives: Dietary Supplement: Beta-hydroxy-beta-methylbutyrate (HMB); Behavioral: Home-based multicomponent exercise program |
| Creatine + HMB + Exercise | Experimental | 3 g/day creatine monohydrate + 3 g/day beta-hydroxy-beta-methylbutyrate (HMB) for 12 weeks plus the individualized home-based multicomponent exercise program. Receives: Dietary Supplement: Creatine monohydrate; Dietary Supplement: Beta-hydroxy-beta-methylbutyrate (HMB); Behavioral: Home-based multicomponent exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Functional Capacity (TFC)
Unified Huntington's Disease Rating Scale (UHDRS) Total Functional Capacity score, range 0-13; higher scores indicate better functional capacity. Change from baseline will be compared across the four arms.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Secondary outcomes (20)
Change in Functional Assessment Scale (FAS)
UHDRS Functional Assessment Scale, 25 yes/no items, range 0-25; higher scores indicate better function.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Independence Scale (IS)
UHDRS Independence Scale, range 10-100 in 5-point steps; higher scores indicate greater independence.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Gait Speed
Usual gait speed (m/s) measured over a standardized walking course.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Rate of Force Development (RFD) 0-200 ms
Rate of force development (RFD) from 0 to 200 ms (N/s) during maximal isometric knee extension measured with a force transducer (best of three 5-s trials).
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Peak Force
Peak force (N) during maximal isometric knee extension measured with a force transducer (best of three 5-s trials).
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Contraction Time
Contraction time (ms) during maximal isometric knee extension measured with a force transducer (best of three 5-s trials).
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Fat-Free Mass (FFM)
Fat-free mass (FFM, kg) assessed by multifrequency bioelectrical impedance analysis (BIA).
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Fat Mass (FM)
Fat mass (FM, kg) assessed by multifrequency bioelectrical impedance analysis (BIA).
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Fat-Free Mass Index (FFMI)
Fat-free mass index (FFMI, kg/m^2) assessed by multifrequency bioelectrical impedance analysis (BIA).
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Fat Mass Index (FMI)
Fat mass index (FMI, kg/m^2) assessed by multifrequency bioelectrical impedance analysis (BIA).
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Mini-Mental State Examination (MMSE) Score
MMSE total score, range 0-30; higher scores indicate better global cognitive function. Part of the Enroll-HD cognitive battery.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Symbol Digit Modalities Test (SDMT), Oral Version
Number of correct responses in 90 seconds on the oral version of the SDMT; higher scores indicate better performance. Part of the Enroll-HD cognitive battery.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Stroop Test Performance
Number of correct responses in 45 seconds on the Stroop test; higher scores indicate better performance. Part of the Enroll-HD cognitive battery.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Trail Making Test Part A (TMT-A) Completion Time
Time to complete Trail Making Test Part A (seconds); lower values indicate better performance. Part of the Enroll-HD cognitive battery.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Trail Making Test Part B (TMT-B) Completion Time
Time to complete Trail Making Test Part B (seconds); lower values indicate better performance. Part of the Enroll-HD cognitive battery.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Semantic Verbal Fluency
Number of words produced in 60 seconds in a semantic (category) verbal fluency task; higher scores indicate better performance. Part of the Enroll-HD cognitive battery.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Phonemic Verbal Fluency
Number of words produced in 60 seconds in a phonemic (letter) verbal fluency task; higher scores indicate better performance. Part of the Enroll-HD cognitive battery.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)
SF-12 Physical Component Summary score, range 0-100; higher scores indicate better physical health-related quality of life.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)
SF-12 Mental Component Summary score, range 0-100; higher scores indicate better mental health-related quality of life.
Measured: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Number of Participants With Adverse Events and Falls
Adverse events and serious adverse events (including falls, emergency visits and hospitalizations) related or unrelated to supplementation, exercise or blood sampling; causality assessed with the Spanish Pharmacovigilance System algorithm.
Measured: From informed consent until 30 days after the end of supplementation (week 16), plus clinically relevant events up to 6 months after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four-arm parallel-group trial (placebo, creatine, beta-hydroxy-beta-methylbutyrate \[HMB\], creatine+HMB); all arms also receive the same individualized home-based multicomponent exercise program. Allocation ratio 1:1:1:1. 12-week intervention followed by a 6-month supplementation-free follow-up.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Burgos, Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Miriam Saiz Rodríguez, PhD, Principal investigator, Universidad de BurgosJuan Francisco Mielgo Ayuso, PhD, Principal investigator, Universidad de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902206
- Sponsor's protocol ID
- SARCO-HD
- Other IDs
- PI26/00439, CEIm 3557
- Acronym
- SARCO-HD
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be shared upon reasonable request to the principal investigators.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07902206
- Acronym / sponsor ID
- SARCO-HD / SARCO-HD
- Conditions
- Huntington Disease, Sarcopenia, Frailty
- Keywords
- Creatine, Beta-hydroxy-beta-methylbutyrate (HMB), Multicomponent exercise, microRNA, Extracellular vesicles, Proteomics, Pharmacogenetics, Neuromuscular function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Collaborators
- Hospital Universitario de Burgos, Instituto de Salud Carlos III
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design: randomized, double-blind, placebo-controlled, four-arm parallel-group trial conducted at the Neurology Department of Hospital Universitario de Burgos (HUBU; recruitment, clinical assessment, biological sampling) and the University of Burgos (UBU; exercise physiology, functional testing and multi-omic analyses).
Randomization: computer-generated permuted blocks of variable size (REDCap), 1:1:1:1 allocation, stratified by sex, antipsychotic use, participation in structured exercise programs and diabetes. Allocation is performed and concealed by an independent pharmacist (HUBU Pharmacy Service). Participants, intervention staff, outcome assessors and data analysts are blinded; supplements are packed in identical coded sachets.
Interventions: once daily for 12 weeks, dissolved in 100 mL fruit juice with the evening meal: (1) 3 g creatine monohydrate + 3 g microcrystalline cellulose; (2) 3 g beta-hydroxy-beta-methylbutyrate (HMB) + 3 g cellulose; (3) 3 g creatine + 3 g HMB; (4) placebo, 6 g microcrystalline cellulose. All participants follow a Mediterranean-style diet (protein 1.2-1.5 g/kg/day) and an individualized home-based multicomponent exercise program based on VIVIFRAIL, prescribed and supervised by an occupational therapist, with weekly phone calls to monitor adherence, perceived exertion (target Borg rating of perceived exertion [RPE] 12-15) and adverse events. Adherence is monitored by intake logs and sachet counts.
Assessments: baseline (T0), week 12 (T1, end of intervention) and 6-month follow-up (T2). Functional capacity (Unified Huntington's Disease Rating Scale [UHDRS] Total Functional Capacity [TFC], Functional Assessment Scale, Independence Scale, gait speed, Short Physical Performance Battery [SPPB]), body composition (multifrequency bioimpedance), neuromuscular function (rate of force development and peak force during isometric knee extension), cognition (Mini-Mental State Examination [MMSE], Symbol Digit Modalities Test [SDMT], Stroop test, Trail Making Test [TMT], verbal fluency), quality of life (12-Item Short Form Health Survey [SF-12]) and adverse events. Fasting blood samples for small RNA sequencing (RNA-seq) of circulating and extracellular-vesicle microRNAs (with quantitative polymerase chain reaction [qPCR] validation), plasma proteomics (Olink Reveal, 1,034 proteins) and pharmacogenetics (15 single nucleotide polymorphisms [SNPs] in SLC6A8, CKM, GATM, MTOR, AKT1, PTEN; genome-wide genotyping in a subset).
Sample size: 64 participants (16 per arm) are needed to detect a small-to-moderate effect (f = 0.20) on change in TFC (alpha 0.05, power 0.80, r = 0.50); allowing for 25-30% dropout, 84-88 participants will be enrolled.
Statistical analysis: intention-to-treat and per-protocol analyses; linear mixed-effects models with Group x Time interaction and pre-specified contrasts of creatine (CRE)+HMB versus each single supplement and placebo; multi-omic integration (mixOmics/DIABLO, MOFA+, elastic net, random forest) with repeated nested cross-validation to identify predictive signatures of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Four-arm parallel-group trial (placebo, creatine, beta-hydroxy-beta-methylbutyrate [HMB], creatine+HMB); all arms also receive the same individualized home-based multicomponent exercise program. Allocation ratio 1:1:1:1. 12-week intervention followed by a 6-month supplementation-free follow-up.
| Arm | Type | Receives |
|---|---|---|
| Placebo + Exercise | Placebo comparator | Dietary Supplement: Placebo (microcrystalline cellulose), Behavioral: Home-based multicomponent exercise programPlacebo (6 g/day microcrystalline cellulose) for 12 weeks plus the individualized home-based multicomponent exercise program. |
| Creatine + Exercise | Experimental | Dietary Supplement: Creatine monohydrate, Behavioral: Home-based multicomponent exercise program3 g/day creatine monohydrate + 3 g/day microcrystalline cellulose for 12 weeks plus the individualized home-based multicomponent exercise program. |
| Beta-Hydroxy-Beta-Methylbutyrate (HMB) + Exercise | Experimental | Dietary Supplement: Beta-hydroxy-beta-methylbutyrate (HMB), Behavioral: Home-based multicomponent exercise program3 g/day beta-hydroxy-beta-methylbutyrate (HMB) + 3 g/day microcrystalline cellulose for 12 weeks plus the individualized home-based multicomponent exercise program. |
| Creatine + HMB + Exercise | Experimental | Dietary Supplement: Creatine monohydrate, Dietary Supplement: Beta-hydroxy-beta-methylbutyrate (HMB), Behavioral: Home-based multicomponent exercise program3 g/day creatine monohydrate + 3 g/day beta-hydroxy-beta-methylbutyrate (HMB) for 12 weeks plus the individualized home-based multicomponent exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Severe dysphagia preventing safe intake of thickened liquids (unless a clinically acceptable alternative exists).
- Allergy or intolerance to any supplement component.
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine monohydrate3 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. | Dietary supplement | Creatine + Exercise, Creatine + HMB + Exercise |
| 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. | Dietary supplement | Beta-Hydroxy-Beta-Methylbutyrate (HMB) + Exercise, Creatine + HMB + Exercise |
| 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. | Dietary supplement | Placebo + Exercise |
| Home-based multicomponent exercise program12-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). | Behavioural | Beta-Hydroxy-Beta-Methylbutyrate (HMB) + Exercise, Creatine + Exercise, Creatine + HMB + Exercise, Placebo + Exercise |
Primary outcome
Change in Total Functional Capacity (TFC)
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Unified Huntington's Disease Rating Scale (UHDRS) Total Functional Capacity score, range 0-13; higher scores indicate better functional capacity. Change from baseline will be compared across the four arms.
20 secondary outcomes
Change in Functional Assessment Scale (FAS)
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Independence Scale (IS)
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Gait Speed
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Rate of Force Development (RFD) 0-200 ms
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Peak Force
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Contraction Time
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Fat-Free Mass (FFM)
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Fat Mass (FM)
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Fat-Free Mass Index (FFMI)
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Fat Mass Index (FMI)
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Mini-Mental State Examination (MMSE) Score
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Symbol Digit Modalities Test (SDMT), Oral Version
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Stroop Test Performance
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Trail Making Test Part A (TMT-A) Completion Time
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Trail Making Test Part B (TMT-B) Completion Time
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Semantic Verbal Fluency
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in Phonemic Verbal Fluency
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Change in 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)
Time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention
Number of Participants With Adverse Events and Falls
Time frame: From informed consent until 30 days after the end of supplementation (week 16), plus clinically relevant events up to 6 months after the end of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be shared upon reasonable request to the principal investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miriam Saiz Rodríguez, PhD principal investigator
Universidad de Burgos
Juan Francisco Mielgo Ayuso, PhD principal investigator
Universidad de Burgos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine monohydrate, Beta-hydroxy-beta-methylbutyrate (HMB) and Home-based multicomponent exercise program in people with Huntington Disease and Sarcopenia, run by Universidad de Burgos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Saiz Rodríguez, PhD (+34 947 49 91 21, miriamsr@ubu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Functional Capacity (TFC) (time frame: Baseline, week 12 (end of intervention) and 6 months after the end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.