Reversibility of Propylene Glycol/Glycerol Intake Effects on Cardiorespiratory Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in cardiorespiratory function
研究概览
简要总结
Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown.
详细描述
Background. Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown. Weaning of propylene glycol/glycerol could allows a quick clearance of propylene glycol/glycerol from the body, with subsequent recovery of cardiorespiratory function.
Specific aim of the research. This research proposal tests the following hypothesis regarding the reversibility of propylene glycol/glycerol and nicotine intake:
- Propylene glycol/glycerol cessation restores cardiorespiratory function.
- Chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine proteomics profile, which are partially reversed after cessation.
- Chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine metabolomics profile, which are partially reversed after cessation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject must be regular propylene glycol/glycerol/nicotine intake users since at least 1 year
- •Subject must be former smokers
排除标准
- •Chronic or acute illness
- •Substance abuse
- •Chronic medication intake
研究组 & 干预措施
Nicotine free intake
The participant will wean off nicotine during five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.
干预措施: Nicotine free intake (Other)
Nicotine intake
The participant will pursuit his regular nicotinic propylene/glycerol intake five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol/nicotine (mix 50:50) intake.
干预措施: Nicotine intake (Other)
Cessation intake
The participant will completely stop his regular nicotinic propylene/glycerol intake during five days before the session. At the start of the experimental session, participants will mimick intake with the device turns off.
干预措施: Cessation intake (Other)
结局指标
主要结局
Change in cardiorespiratory function
时间窗: 4 hours
Continuous monitoring of cardiorespiratory function
次要结局
- Change in serum and urine proteomics profiles(1 hour)
研究者
Martin Chaumont
Principal investigator
Université Libre de Bruxelles