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Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome

RecruitingNAAges 18 Years - anyAllUniversidad de Burgos
NCT07213063 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Nutrition education
  • Supplement
  • Placebo
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Where

1 site
Universidad de Burgos
Burgos, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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