Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Str… (NCT07213063) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome
Spain50 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
18 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:
* 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).
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
Lean mass
Timeframe: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)