Neuromuscular and Multi-Omics Synergy of Combined Creatine × HMB Supplementation Plus Exercise to… (NCT07275996) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Neuromuscular and Multi-Omics Synergy of Combined Creatine × HMB Supplementation Plus Exercise to Improve Muscle Function in Sarcopenic Frailty
Spain50 participantsStarted 2026-03-10
Plain-language summary
Sarcopenia and physical frailty are highly prevalent among institutionalized older adults and are major contributors to functional decline, reduced mobility, and loss of independence. Combined exercise and targeted nutritional strategies have emerged as promising approaches to mitigate these age-related impairments.
This randomized, double-blind, placebo-controlled, parallel-group clinical trial aims to evaluate the independent and combined effects of creatine monohydrate (CRE) and β-hydroxy-β-methylbutyrate (HMB), administered alongside a supervised multicomponent exercise program, on physical function, body composition, cognitive performance, and quality of life in institutionalized older adults with physical frailty and sarcopenia.
A total of 50 adults aged ≥65 years were enrolled and randomized to one of four intervention groups for 12 weeks: placebo plus exercise, creatine plus exercise, HMB plus exercise, or creatine plus HMB plus exercise. A supplement-free follow-up period will be conducted to evaluate the sustainability of intervention effects.
In addition to clinical and functional outcomes, the study incorporates molecular and biological assessments to explore mechanistic pathways underlying functional adaptation and interindividual variability in response to the interventions.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Institutionalized older adults (≥65 years) residing in the Fuentes Blancas Nursing Home (Diputación de Burgos).
* Clinical diagnosis of frailty or sarcopenia according to validated criteria (e.g., Fried phenotype, SPPB ≤ 9, or low ALMI by DEXA).
* Ability to participate in an exercise program as assessed by the medical staff.
* Written informed consent provided by the participant or, if cognitively impaired, by a legally authorized representative.
Exclusion Criteria:
* Severe renal insufficiency (eGFR \< 30 mL/min/1.73m²) or liver failure.
* Advanced heart failure (NYHA class III-IV) or unstable cardiovascular disease.
* Active cancer or other severe medical conditions that contraindicate participation.
* Severe cognitive impairment (MMSE \< 10) precluding adherence to the program without caregiver support.
* Known allergy or intolerance to creatine, HMB, or inulin.
* Participation in another clinical trial within the past 3 months.
* Any condition that, in the opinion of the medical team, may compromise safety or adherence to the intervention.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Short Physical Performance Battery (SPPB)
Timeframe: Baseline, Week 12 (end of intervention), and 3-month follow-up
2
Timed Up and Go (TUG)
Timeframe: Baseline, Week 12 (end of intervention), and 3-month follow-up
3
Appendicular Lean Mass (ALM, kg) by DEXA
Timeframe: Baseline, Week 12 (end of intervention), and 3-month follow-up