Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome
Condition(s) studied
Investigational drug(s) / intervention(s)
Nutrition education: Participants and their families will also take part in nutrition education sessions to promote healthy eating and lifestyle habits.
Supplement: Supplementation with 3 g/day of creatine monohydrate abd 3 g/day of beta-hydroxy-beta-methylbutyrate for 8 weeks
Placebo: Supplementation with 6 g/day of inulin orally for 8 weeks
Study 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
Primary outcome measure(s)
- Lean mass — Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Lean mass (kg) will be evaluated using dual-energy X-ray absorptiometry (DXA): GE Lunar Prodigy DXA device (GE Healthcare, Madison, WI, USA; Encore software version).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Universidad de Burgos | Burgos | Burgos | Recruiting |
More Universidad de Burgos trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07213063 on ClinicalTrials.gov ↗ ← All trials in Spain