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

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.

NCT Number	NCT07213063
Lead Sponsor	Universidad de Burgos Collaborators: European University Miguel de Cervantes
Conditions	Down Syndrome (DS), Supplementation
Enrollment	50 participants
Start Date	2025-09-15
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-14