NCT04783207已完成不适用
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance in Athletes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amazentis SA
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in race performance time during a 3000 m track race in elite runners
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study enrolling 36 (16 Elite and 20 Sub-Elite trained endurance runners (18 placebo and 18 Mitopure intervention) who are 18-40 years of age. Mitopure or Placebo supplement, will be given as a daily oral dose for 4-weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18-40 years
- •Participants will be running >100 km/week
- •Elite participants will be required to have a 3,000 m running personal best time below 9:00 (mm:ss), and/or a VO2max result greater than 65 ml·kg-1·min-1
- •The sub-elite cohort will have a 3,000 m running personal best faster than 10:00 min and/or a VO2max >60 ml·kg-1·min-1
- •Agree to participate in one of two ~4 week training camps been held between March-October
- •Signed informed consent
排除标准
- •Subjects with diagnosed medical conditions involving thyroid function or other chronic disturbances of metabolic rate
- •Subjects who are unable to complete the training or testing protocols
结局指标
主要结局
Change in race performance time during a 3000 m track race in elite runners
时间窗: 4-weeks
Change in plasma levels over time of creatine kinase (CK)
时间窗: 4 weeks
Muscle damage and recovery biomarker
次要结局
- Change from baseline in maximal muscle strength during 1-repetition maximum leg press(4-weeks)
- Change from baseline in running economy via indirect calorimetry(4-weeks)
- change in iron absorption and hemoglobin mass via determination of carboxyhaemoglobin (percent HbCO)(4-weeks)
- Change from baseline in lean body mass via Dual-energy X-ray Absorptiometry (DXA)(4-weeks)
- change in plasma levels of inflammatory marker CRP(4-weeks)
- change in mitochondrial function via respirometry in muscle biopsies (sub-elite runners only)(4-weeks)
- change in mitochondrial gene expression via RNA-seq in muscle biopsies (sub-elite runners only)(4-weeks)
- change in plasma levels of Urolithin A(4-weeks)
- Change from baseline in Resting Metabolic Rate (RMR)(4-weeks)
- Change in acylcarnitines levels via metabolomics in plasma(4-weeks)
- Change from baseline in aerobic capacity (VO2max)(4-weeks)
- Change from baseline in body fat mass via Dual-energy X-ray Absorptiometry (DXA)(4-weeks)
研究者
研究点 (1)
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