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

NCT07213063 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

  • Down Syndrome (DS)
  • Supplementation

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

Sponsors & Collaborators

  • European University Miguel de Cervantes

    collaborator OTHER

  • Universidad de Burgos

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-04-30
Completion
2026-05-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07213063 on ClinicalTrials.gov