Actively Recruiting
Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome
Led by Universidad de Burgos · Updated on 2026-01-14
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
Universidad de Burgos
Lead Sponsor
E
European University Miguel de Cervantes
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether 8 weeks of daily supplementation with creatine monohydrate and beta-hydroxy-beta-methylbutyrate (HMB) can improve muscle strength, body composition, balance, cognitive function, and overall health in individuals with Down syndrome. This study is a randomized, placebo-controlled crossover trial that also includes nutritional education to support a balanced diet. The study aims to assess the effects of these supplements on oxidative stress and inflammation markers as well. Participants will take either 3 grams per day of creatine combined with 3 grams per day of HMB or a placebo (6 grams per day of inulin) orally for 8 weeks. After the first phase, participants will switch to the other supplementation for another 8 weeks. Nutritional education sessions will be provided throughout the intervention to promote healthy eating and lifestyle habits. Participants will undergo assessments before and after each supplementation period, including body composition scans using dual-energy X-ray absorptiometry (DXA) and bioimpedance, muscle strength tests like handgrip and lower limb strength, balance tests, cognitive function assessments, and blood tests to measure biomarkers of oxidative stress and inflammation. These evaluations will help researchers understand the physiological and functional effects of the supplements in people with Down syndrome. The total duration of participation spans across both 8-week supplementation periods with all tests conducted at baseline and at the end of each phase.
CONDITIONS
Brief Title
Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medical confirmation of Down syndrome (trisomy of chromosome 21)
- Ability to perform basic physical tests such as standing up from a chair or walking without assistance
- Informed consent obtained from both the participant and their legal representative according to current legislation
You will not qualify if you...
- Diagnosis of chronic kidney disease
- Severe motor limitations preventing performance of required physical tests
- Participation in another nutritional or supplementation intervention study within the last 6 months
- Known allergy to creatine or to components of the placebo (inulin)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks per supplementation phase
Participants receive daily supplementation with either creatine monohydrate and beta-hydroxy-beta-methylbutyrate or placebo for 8 weeks, along with nutrition education sessions to support a balanced diet.
Baseline and end-of-supplementation visits for each 8-week phase
Duration - 8 weeks per supplementation phase
Participants cross over to the alternate supplementation (creatine and HMB or placebo) for another 8 weeks, continuing nutrition education.
Baseline and end-of-supplementation visits for each 8-week phase
Trial Site Locations
Total: 1 location
1
Universidad de Burgos
Burgos, Burgos, Spain, 09003
Actively Recruiting
Research Team
A
Alba Abia Heras, Nutrition and Dietetics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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