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

Universidad de Burgos

Status: Enrolling

Conditions: Supplementation; Down Syndrome (DS)

Treatments: Other: Nutrition education; Dietary Supplement: Placebo; Dietary Supplement: Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT07213063

CreatineSDown.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Placebo

Active Comparator group

Description:

Participants will receive placebo supplementation

Treatment:

Dietary Supplement: Placebo

Other: Nutrition education

Supplementation

Experimental group

Description:

Participants will receive creatine monohydrate and beta-hydroxy-beta-methylbutyrate supplementation

Treatment:

Dietary Supplement: Supplement

Other: Nutrition education