Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutrition education, Supplement, Placebo.
- Who it may be relevant to
- Registry conditions: Down Syndrome (DS), Supplementation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Lean mass [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
Secondary outcome measures (12)
- Handgrip strength [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Bone mineral density [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Reduced glutathione (GSH). [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- C-reactive protein (CRP) [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Superoxide dismutase (SOD) activity. [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Blood levels of interleukins (IL-1, IL-6, IL-7). [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Tumor necrosis factor-alpha (TNF-α). [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Fat-free mass [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Lower limb strength [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Balance [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Cognitive function [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Isometric lower body strength [Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- Universidad de Burgos — Burgos
Identifiers
NCT: NCT07213063 · CreatineSDown.