Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07213063

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

36 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

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

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 the participant and their legal representative
Not Eligible

You will not qualify if you...

  • Diagnosis of chronic kidney disease
  • Severe motor limitations preventing required physical tests
  • Participation in another nutritional or supplementation study within the last 6 months
  • Known allergy to creatine or components of the placebo (inulin)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Universidad de Burgos

Burgos, Burgos, Spain, 09003

Actively Recruiting

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Research Team

A

Alba Abia Heras, Nutrition and Dietetics

CONTACT

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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