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| Name | Class |
|---|---|
| European University Miguel de Cervantes | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Active Comparator | Participants will receive placebo supplementation |
|
| Supplementation | Experimental | Participants will receive creatine monohydrate and beta-hydroxy-beta-methylbutyrate supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition education | Other | Participants and their families will also take part in nutrition education sessions to promote healthy eating and lifestyle habits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Handgrip strength | Handgrip strength (kg) will be assessed using a handgrip dynamometer. | Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation) |
| Bone mineral density |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alba Abia Heras, Nutrition and Dietetics | Contact | 615 18 16 15 | +34 | aheras@uemc.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Burgos | Recruiting | Burgos | Burgos | 09003 | Spain |
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| Supplement | Dietary Supplement | Supplementation with 3 g/day of creatine monohydrate abd 3 g/day of beta-hydroxy-beta-methylbutyrate for 8 weeks |
|
| Placebo | Dietary Supplement | Supplementation with 6 g/day of inulin orally for 8 weeks |
|
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).
| 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). | 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). | 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. | 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). | 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). | 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. | 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. | 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:
| 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. | 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 | 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. | Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation) |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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