Use of Endogenous Melatonin and 6-hydroxymelatonin as Biomarkers for CYP1A2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Validation LC-MS/MS analytical method
研究概览
简要总结
An observational study comprising 4 sessions will be conducted in 12 healthy volunteers. During each study session (sessions 1 to 4), a 12-hour urine collection during the night (21h-9h) will be carried out by each participant. The first urine in the morning will be collected separately to be analysed independently of the 12-hour collection. 24 hours before the start of the night urine collection, volunteers will be asked to refrain from consuming alcohol and caffeinated drinks/foods, with the exception of session 3. Conversely, in session 3, subjects will be asked to drink or eat caffeinated food/drinks 24 hours prior to night-time urine collection (at least one cup of coffee or a can of Coca-Cola®).
After each 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •Understanding of French language and ability to give a written informed consent
排除标准
- •Inability to refrain from alcohol or methylxanthine-containing beverages and foods for 24 hours
- •Sensitivity to coffee or CocaCola®
- •Irregular (i.e. non-daily or inconstant dosages) intake of medication or food of a CYP1A2 modulator (including tobacco)
结局指标
主要结局
Validation LC-MS/MS analytical method
时间窗: 1 month
Validation of the LC-MS/MS analytical method for simultaneous quantification of endogenous melatonin and 6-hydroxymelatonin in urine samples
次要结局
- Correlation melatonin and caffeine(4 days (day 1, day 4, day 15 and day 30))
- Intra- and inter-variability(3 days (day 1, day 4 and day 30))
- Urine correlation(4 days (day 1, day 4, day 15 and day 30))
- Impact caffeine intake(1 day (day 15))
研究者
Youssef Daali
Professor Youssef Daali
University Hospital, Geneva
