Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lean mass
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Placebo
Participants will receive placebo supplementation
干预措施: Nutrition education (Other)
Placebo
Participants will receive placebo supplementation
干预措施: Placebo (Dietary Supplement)
Supplementation
Participants will receive creatine monohydrate and beta-hydroxy-beta-methylbutyrate supplementation
干预措施: Nutrition education (Other)
Supplementation
Participants will receive creatine monohydrate and beta-hydroxy-beta-methylbutyrate supplementation
干预措施: Supplement (Dietary Supplement)
结局指标
主要结局
Lean mass
时间窗: 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).
次要结局
- 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))
- Blood 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).(Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation))
- Fat-free mass(Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation))
- Lower limb strength(Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation))
- Balance(Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation))
- Cognitive function(Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation))
- Isometric lower body strength(Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation))
- Isometric upper body strength(Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation))
研究者
MARIA MARTINEZ
Principal Investigator
Universidad de Burgos