NCT07213063 Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome
| NCT ID | NCT07213063 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de Burgos |
| Condition | Down Syndrome (DS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-09-15 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Purpose: This study will test whether 8 weeks of creatine and HMB supplementation can improve muscle strength, body composition, balance, and overall health in people with Down syndrome. Participants will also receive nutrition tips during the study. Who can participate: People with Down syndrome who can perform basic physical tasks. Must provide consent from the participant and legal guardian. What participants will do: Take creatine (3 g/day) and HMB (3 g/day) or placebo for 8 weeks. Complete tests for muscle strength, balance, and cognitive function. Undergo body composition scans and give blood samples for health markers. Timing: All tests and blood samples are taken before and after each 8-week period. Importance: Results will help determine if creatine and HMB can safely improve strength, balance, and overall health in people with Down syndrome.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07213063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Down Syndrome (DS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07213063 currently recruiting?
Yes, NCT07213063 is actively recruiting participants. Contact the research team at aheras@uemc.es for enrollment information.
Where is the NCT07213063 trial being conducted?
This trial is being conducted at Burgos, Spain.
Who is sponsoring the NCT07213063 clinical trial?
NCT07213063 is sponsored by Universidad de Burgos. The trial plans to enroll 50 participants.