Status:
RECRUITING
Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome
Lead Sponsor:
Universidad de Burgos
Collaborating Sponsors:
European University Miguel de Cervantes
Conditions:
Down Syndrome (DS)
Supplementation
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
This study is an 8-week randomized, placebo-controlled, crossover trial designed to evaluate the effects of daily supplementation with creatine monohydrate (3 g) and beta-hydroxy-beta-methylbutyrate (...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07213063
Start Date
September 15 2025
End Date
April 1 2026
Last Update
October 8 2025
Active Locations (1)
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1
Universidad de Burgos
Burgos, Burgos, Spain, 09003