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

Healthy Clinical Trial

— MelaCYP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420611
• Other study ID #: 2020-00125
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Session 1 (day 1)
12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods. After the 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®.
• Session 2 (day 3)
12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods. After the 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®.
• Session 3 (day 15)
12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers 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 the 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®.
• Session 4 (day 30)
12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods. After the 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®.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Youssef Daali

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)