Down Syndrome (DS)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
A study testing Nutrition education and Supplement in people with Down Syndrome (DS) and Supplementation, run by Universidad de Burgos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Down Syndrome (DS), Supplementation
- What is being tested?
- Nutrition education and Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Down Syndrome (DS), Supplementation
- Being tested
- Nutrition education, Supplement, Placebo
- Keywords
- creatine, down syndrome, bone mineral health
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educationOther
Participants and their families will also take part in nutrition education sessions to promote healthy eating and lifestyle habits.
SupplementDietary supplement
Supplementation with 3 g/day of creatine monohydrate abd 3 g/day of beta-hydroxy-beta-methylbutyrate for 8 weeks
PlaceboDietary supplement
Supplementation with 6 g/day of inulin orally for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Active comparator | Participants will receive placebo supplementation Receives: Other: Nutrition education; Dietary Supplement: Placebo |
| Supplementation | Experimental | Participants will receive creatine monohydrate and beta-hydroxy-beta-methylbutyrate supplementation Receives: Other: Nutrition education; Dietary Supplement: Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Secondary outcomes (13)
Handgrip strength
Handgrip strength (kg) will be assessed using a handgrip dynamometer.
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Bone mineral density
Total bone mineral density (g/cm2) will be evaluated using dual-energy X-ray absorptiometry (DXA): GE Lunar Prodigy DXA device (GE Healthcare, Madison, WI, USA; Encore software version).
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Reduced glutathione (GSH).
Blood samples will be collected to assess levels of reduced glutathione (GSH).
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
C-reactive protein (CRP)
Blood samples will be collected to assess levels of inflammation including C-reactive protein (CRP).
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Superoxide dismutase (SOD) activity.
Blood samples will be collected to assess levels of superoxide dismutase (SOD) activity.
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Blood levels of interleukins (IL-1, IL-6, IL-7).
Blood samples will be collected to assess levels of interleukins (IL-1, IL-6, IL-7).
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Tumor necrosis factor-alpha (TNF-α).
Blood samples will be collected to assess levels of tumor necrosis factor-alpha (TNF-α).
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Fat-free mass
Fat free mass (kg) will be analysed using bioimpedance: InBody S10.
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Lower limb strength
Lower limb strength will be assessed using the Five Times Sit-to-Stand Test (5xSTS), which involved recording the time taken to rise from a 45 cm highchair five times as quickly as possible without using the arms for support.
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Balance
Balance will be using the 4-Stage Balance Test. It involves holding four progressively difficult positions for at least 10 seconds each:
Feet together: 1 point if the position is held for 10 seconds or more. Partial semi-tandem: 1 point if the position is held for 10 seconds or more.
Semi-tandem:
- 2 points: If the position is held for more than 10 seconds.
- 1 point: If the position is held for between 3 and 9.99 seconds.
- 0 points: If the position is held for less than 3 seconds. The score ranges from 0 to 4 (best balance).
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Cognitive function
Cognitive function will be assessed with Timed Up and Go Dual Task (TUGdt) test.
The participant first performs the Timed Up and Go (TUG) test alone, standing up from a chair, walking a short distance (3 meters) turning, and sitting back down, while simultaneously naming animals within a 10-second period, which assesses verbal fluency.
The time taken to complete these distances will be recorded, and the fluency in naming the animals will be assessed.
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Isometric lower body strength
The K-Pull test will be used to evaluate isometric lower body strength
Participants will perform a seated knee extension test, pushing their leg against the dynamometer with maximal effort. Participants will exert their maximum force against the unyielding device for 3-5 seconds. The peak force achieved (in Newtons) over a minimum of two trials will be recorded
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Isometric upper body strength
The K-Pull test will be used to evaluate isometric upper body strength
Participants will stand with their back against a wall to stabilize the torso. The participant will be instructed to exert a maximal force by pushing their arm outward against the device for 3-5 seconds.The peak force achieved (in Newtons or kilograms-force) over a minimum of two trials will be recorded.
Measured: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start15 Sep 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down Syndrome (DS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Collaborators
- European University Miguel de Cervantes
- Responsible party
- Principal investigator, MARIA MARTINEZ, Universidad de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213063
- Sponsor's protocol ID
- CreatineSDown.
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07213063
- Acronym / sponsor ID
- CreatineSDown.
- Conditions
- Down Syndrome (DS), Supplementation
- Keywords
- creatine, down syndrome, bone mineral health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Collaborators
- European University Miguel de Cervantes
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Other: Nutrition education, Dietary Supplement: PlaceboParticipants will receive placebo supplementation |
| Supplementation | Experimental | Other: Nutrition education, Dietary Supplement: SupplementParticipants will receive creatine monohydrate and beta-hydroxy-beta-methylbutyrate supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition educationParticipants and their families will also take part in nutrition education sessions to promote healthy eating and lifestyle habits. | Other | Placebo, Supplementation |
| SupplementSupplementation with 3 g/day of creatine monohydrate abd 3 g/day of beta-hydroxy-beta-methylbutyrate for 8 weeks | Dietary supplement | Supplementation |
| PlaceboSupplementation with 6 g/day of inulin orally for 8 weeks | Dietary supplement | Placebo |
Primary outcome
Lean mass
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
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).
13 secondary outcomes
Handgrip strength
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Bone mineral density
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Reduced glutathione (GSH).
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
C-reactive protein (CRP)
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Superoxide dismutase (SOD) activity.
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Blood levels of interleukins (IL-1, IL-6, IL-7).
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Tumor necrosis factor-alpha (TNF-α).
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Fat-free mass
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Lower limb strength
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Balance
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Cognitive function
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Isometric lower body strength
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Isometric upper body strength
Time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education and Supplement in people with Down Syndrome (DS) and Supplementation, run by Universidad de Burgos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean mass (time frame: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.