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

ConditionsDown Syndrome (DS)Supplementation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversidad de Burgos

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: PlaceboActive comparator 2 interventions

Group B: SupplementationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Lean mass

Lean mass (kg) will be evaluated using dual-energy X-ray absorptiometry (DXA): GE Lunar Prodigy DXA device (GE Healthcare, Madison, WI, USA; Encore software version).

Time frame