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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Universidad de Burgos
RECRUITING
Burgos
Contact Information
Primary
Alba Abia Heras, Nutrition and Dietetics
aheras@uemc.es
615 18 16 15
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 50
Treatments
Active_comparator: Placebo
Placebo supplementation with 6 g/Day of inuline
Experimental: Supplementation
3 g/day of creatine monohydrate and 3 g/day of beta hydroxymethylbutyrate
Related Therapeutic Areas
Sponsors
Collaborators: European University Miguel de Cervantes
Leads: Universidad de Burgos

This content was sourced from clinicaltrials.gov