Creatine plus HMB to improve strength, balance, and body composition in people with Down syndrome
Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome
This study will test whether taking creatine (3 g/day) and HMB (3 g/day) for 8 weeks can help people with Down syndrome gain strength, improve body composition, balance, and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad de Burgos Academic / other |
| Locations | 1 site (Burgos, Burgos) |
| Trial ID | NCT07213063 on ClinicalTrials.gov |
What this trial studies
This is an 8-week randomized, placebo-controlled, crossover trial in which participants with Down syndrome receive daily creatine monohydrate (3 g) plus HMB (3 g) or placebo, with nutritional education provided throughout. Outcomes are measured at baseline and after each 8-week supplementation period and include DXA-measured lean mass (primary), body composition by bioimpedance, bone mineral density, multiple muscle strength and balance tests, a dual-task cognitive mobility measure, and blood biomarkers of oxidative stress and inflammation. The crossover design allows each participant to serve as their own control, and safety exclusions include chronic kidney disease and known allergies to study supplements or placebo components. All assessments are performed at the Universidad de Burgos site in Burgos, Spain.
Who should consider this trial
Good fit: People with a medical diagnosis of Down syndrome who can perform basic physical tests (for example, stand up from a chair or walk without assistance) and who can provide informed consent together with their legal guardian are eligible.
Not a fit: Individuals with chronic kidney disease, severe motor limitations that prevent required testing, or known allergy/intolerance to creatine or placebo components are unlikely to benefit and may be excluded.
Why it matters
Potential benefit: If effective, this regimen could increase muscle mass and strength, improve balance, and support better daily functioning and health in people with Down syndrome.
How similar studies have performed: Creatine and HMB have shown benefits for muscle mass and strength in older adults and other populations, but evidence specifically in people with Down syndrome is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis: Medical confirmation of Down syndrome (trisomy of chromosome 21). * Physical capacity: Ability to perform basic physical tests (e.g., standing up from a chair or walking without assistance). * Informed consent: Informed consent will be obtained from both the participant and their legal representative, in compliance with current legislation for individuals requiring support measures. Exclusion Criteria: * Chronic kidney disease: Diagnosis of chronic kidney disease. * Severe motor limitations: Inability to perform the required physical tests (e.g., paralysis or mobility impairments preventing the execution of muscle strength assessments). * Participation in other studies: Participation in another nutritional or supplementation intervention study within the last 6 months. * Allergies or intolerances: Known allergy to creatine or to components of the placebo (inulin).
Where this trial is running
Burgos, Burgos
- Universidad de Burgos — Burgos, Burgos, Spain (Recruiting)
Study contacts
- Study coordinator: Alba Abia Heras, Nutrition and Dietetics
- Email: aheras@uemc.es
- Phone: 615 18 16 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.