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Recruiting Not 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

NCT07213063 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2025-09-15
Last updated
2026-01-14

Condition(s) studied

Down Syndrome (DS)Supplementation

Investigational drug(s) / intervention(s)

Nutrition educationSupplementPlacebo

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

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)

FacilityCityRegionStatus
Universidad de Burgos Burgos Burgos Recruiting
Official registry record

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