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临床试验/NCT04420611
NCT04420611已完成不适用

Use of Endogenous Melatonin and 6-hydroxymelatonin as Biomarkers for CYP1A2

Youssef Daali1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年10月1日最近更新:
适应症

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

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

发起方
Youssef Daali
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Youssef Daali

Professor Youssef Daali

University Hospital, Geneva

研究点 (1)

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