NCT07213063

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Universidad de Burgos · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 (HMB, 3 g) on body composition, muscle strength, balance, cognitive function, and biomarkers of oxidative stress and inflammation in individuals with Down syndrome. Participants will receive nutritional education throughout the intervention to support a balanced diet. Primary outcomes include lean mass measured by dual-energy X-ray absorptiometry (DXA). Secondary outcomes include fat-free mass (bioimpedance), bone mineral density (DXA), handgrip strength, lower limb strength (Five Times Sit-to-Stand Test), upper and lower body isometric strength (K-Pull test), balance (4-Stage Balance Test), and cognitive function assessed by the Timed Up and Go Dual Task. Blood biomarkers of oxidative stress and inflammation, including reduced glutathione (GSH), superoxide dismutase (SOD), C-reactive protein (CRP), interleukins (IL-1, IL-6, IL-7), and tumor necrosis factor-alpha (TNF-α), will be assessed before and after each supplementation period. All assessments will be performed at baseline and at the end of each 8-week supplementation phase, allowing for evaluation of both physiological and functional responses to creatine and HMB supplementation in this population.

Conditions

• Down Syndrome (DS)
• Supplementation

Interventions

Type	Name	Description
OTHER	Nutrition education	Participants and their families will also take part in nutrition education sessions to promote healthy eating and lifestyle habits.
DIETARY_SUPPLEMENT	Supplement	Supplementation with 3 g/day of creatine monohydrate abd 3 g/day of beta-hydroxy-beta-methylbutyrate for 8 weeks
DIETARY_SUPPLEMENT	Placebo	Supplementation with 6 g/day of inulin orally for 8 weeks

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-04-30
• Completion: 2026-05-30
• First posted: 2025-10-08
• Last updated: 2026-01-14

Locations

1 site across 1 country: Spain