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 | Recruiting

• 1 other identifier: CreatineSDown.
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

creatine; down syndrome; bone mineral health

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)

Secondary Outcomes (13)

• Handgrip strength

  Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)

• Bone mineral density

  Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)

• Reduced glutathione (GSH).

  Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)

• C-reactive protein (CRP)

  Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)

• Superoxide dismutase (SOD) activity.

  Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)

Study Arms (2)

Placebo

ACTIVE COMPARATOR

Participants will receive placebo supplementation

Other: Nutrition education; Dietary Supplement: Placebo

Supplementation

EXPERIMENTAL

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

Other: Nutrition education; Dietary Supplement: Supplement

Interventions

Nutrition education OTHER

Participants and their families will also take part in nutrition education sessions to promote healthy eating and lifestyle habits.

Placebo; Supplementation

Supplement DIETARY_SUPPLEMENT

Supplementation with 3 g/day of creatine monohydrate abd 3 g/day of beta-hydroxy-beta-methylbutyrate for 8 weeks

Supplementation

Placebo DIETARY_SUPPLEMENT

Supplementation with 6 g/day of inulin orally for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad de Burgos: lead
• European University Miguel de Cervantes: collaborator

Study Sites (1)

Universidad de Burgos

Burgos, Burgos, 09003, Spain

RECRUITING

MeSH Terms

Conditions

Down Syndrome

Interventions

Nutrition Assessment; Dietary Supplements

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Alba Abia Heras, Nutrition and Dietetics

CONTACT

615 18 16 15; aheras@uemc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: September 15, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)