NCT02880657Unknown不适用
Evaluation of SODB®, Associated With a Physical Training, in the Physical Condition Improvement in Healthy Subjects: Randomized Double-blind Study Versus Placebo
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Bionov
- 入组人数
- 42
- 主要终点
- Change from baseline physical condition at 10 weeks
研究概览
简要总结
The objective of this study is to evaluate the influence of a 10 weeks SODB® supplementation in physical condition improvements of healthy subjects, in comparison to a placebo.
详细描述
Beneficial experimental results have already been obtained with SODB®. That is why, the investigators expect several effects of SODB® here. Indeed, this clinical study could show that SODB® is able to improve physical conditions, and particularly at muscular and cardiac levels, by inducing a decrease in oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ruffier score between 8 and 12
- •18.5 < Body Mass Index < 27 kg/m2
- •stable weight (variation < 5% over the last 3 months)
- •stable diet over the last 3 months
- •normal biological exam
- •arterial pressure < 140/90 mm Hg
- •normal ECG
- •no contraindication for running
- •subject having given his free, informed and express consent
- •subject affiliated with a social security insurance or beneficiary of such an insurance system
- •time to go to the physical training twice per week
排除标准
- •subject who do not understand the study
- •> 5 cigarets per day
- •slimming diet over the last 3 months
- •contraindication for running or physical test
- •subject who failed the Cooper test
- •anormal ECG
- •anormal biological results
- •dyslipidemia
- •under current statins treatment
- •hypertension
- •diabeta II
- •chronic respiratory disease
- •rheumatic disease
- •orthopedic disease
- •positive serology for hepatitis B, C or HIV
- •under current corticoids treatment
- •under current drugs (medicine or not)
- •any allergy to utilized one of the compounds of the experimental or placebo product
- •alcool > 36g/day
- •consumption of drinks containing caffein, taurine, creatin, guarana, ginseng, ginkgo, biloba, etc
- •consumption of drinks containing xanthic bases (> 0.5L/day)
- •consumption of drinks containing plants (> 2L/day)
- •consumption of grapefruit juice (> 0.5L/day)
- •under current antioxidant treatment (and during last month)
- •adult protected by the law
- •any subject who participated to a clinical assay within the 3 months
结局指标
主要结局
Change from baseline physical condition at 10 weeks
时间窗: Evaluation performed at inclusion day (V2) and after 5 weeks of treatment (V3) and 10 weeks of treatment at the end of the study (V4)
Evaluation performed by Ruffier test measurement
次要结局
- Evaluation of cardiac frequence(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of maximal aerobic vitesse(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of maximal oxygen volume(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of running time(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of running distance(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of quality of fatigue(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of quality of life(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of glucose blood level(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of insulin blood level(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of cholesterol level(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of cortisol level(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of testosterone level(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of transaminases level(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of triglycerides level(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of inflammation(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of ions modifications(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of creatinemia(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
- Evaluation of lactate level(Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4))
研究者
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