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

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®.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Session 1 (day 1); Other: Session 2 (day 3); Other: Session 3 (day 15); Other: Session 4 (day 30)

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Geneva University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy men and women

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation LC-MS/MS analytical method	Validation of the LC-MS/MS analytical method for simultaneous quantification of endogenous melatonin and 6-hydroxymelatonin in urine samples	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Youssef Daali
• Investigators: Principal Investigator: Youssef Daali, Prof, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020-00125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No