Effets Aigus d'Une supplémentation en polyphénols (Vinitrox™) Contre Placebo Sur la Fonction endothéliale et la Performance Lors d'un Exercice à intensité modérée en Hypoxie Chez Des Volontaires Sains Physiquement Actifs.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Nexira
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Flow mediated dilation (FMD ; %)
研究概览
简要总结
To evaluate the effect of acute polyphenols supplementation on vasodilation and related markers along with exercise related markers (notably performance, respiratory exchanges, perceived exertion), before, during and after a hypoxic moderate-intensity exercise in healthy recreative volunteers.
详细描述
Exercise session is an ergometer cycling workout performed under hypoxia condition equivalent to 3000 meters of altitude. Exercise session is composed of a warmup period followed by 20 minutes of cycling starting at 60% of individual maximal aerobic power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI < 27
- •Abdominal circumference < 94 cm
- •Stable exercise training program during past 2 months
排除标准
- •Total weekly exercise sessions < 4 hours OR > 8 hours
- •Drug or supplement intake during past one month that could interfere with study parameters
- •Volunteer suffering of respiratory or pulmonary condition
- •Volunteer exposed to an altitude > 2000 meters during at least 3 weeks for the past 6 months.
研究组 & 干预措施
Polyphenols extract
Apple and grape polyphenols extract (Vinitrox™) - 250mg per capsule
干预措施: Oral administration (Dietary Supplement)
Placebo
Maltodextrin
干预措施: Oral administration (Dietary Supplement)
结局指标
主要结局
Flow mediated dilation (FMD ; %)
时间窗: Before the exercise session (at rest under normoxia and hypoxia conditions)
Comparison of brachial artery diameter measured by ultrasound, before and after distal cuff-occlusion
次要结局
- Fraction exhaled nitric oxyde (FeNO ; ppb)(Before the exercise session (at rest under normoxia and hypoxia conditions) / After the exercise session (under normoxia condition).)
- Maximal power and Total work (watt)(During exercise session (5 minutes intervals))
- Heart rate (bpm)(Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition))
- Blood pressure (mmHg)(Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition))
- Lactatemia (mmol/L)(During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition))
- Perceived exertion (1-10 scale)(During exercise session (5 minutes intervals))
- Oximetry (SpO2, %)(Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition))
- Muscular oximetry (SmO2, saturation index)(During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition))
- Respiratory gas exchanges (VO2, VCO2 ; mL/min/kg))(Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition))
- Respiratory exchange ratio (RER)(Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition))