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

Completed

• Conditions: Healthy

• Registration Number: NCT04420611
• Lead Sponsor: Youssef Daali

Brief Summary

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®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Study Start: 2020-10-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy men and women
• Understanding of French language and ability to give a written informed consent

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation LC-MS/MS analytical method	1 month	Validation of the LC-MS/MS analytical method for simultaneous quantification of endogenous melatonin and 6-hydroxymelatonin in urine samples

Secondary Outcome Measures

Name	Time	Method
Correlation melatonin and caffeine	4 days (day 1, day 4, day 15 and day 30)	Assess correlation between the endogenous UMR 6-hydroxymelatonin/melatonin and the paraxanthine/caffeine ratio in dried blood spot (DBS)
Intra- and inter-variability	3 days (day 1, day 4 and day 30)	Assess intra- and inter-variability of the urinary metabolic ratio (UMR) 6-hydroxymelatonin/melatonin at three different time (day 1, day 4 and day 30)
Urine correlation	4 days (day 1, day 4, day 15 and day 30)	Assess correlation between 12 hours overnight urine and first morning voids samples
Impact caffeine intake	1 day (day 15)	Assess impact of caffeine intake on the UMR 6-hydroxymelatonin/melatonin (day 15) before and after caffeine abstinence (fold-change measurements)

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland