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

NCT04420611 | Completed

• 1 other identifier: 2020-00125
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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®.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• Correlation melatonin and caffeine

  4 days (day 1, day 4, day 15 and day 30)

• Impact caffeine intake

  1 day (day 15)

Interventions

Session 1 (day 1) OTHER

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) OTHER

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) OTHER

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) OTHER

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®.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy men and women

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Youssef Daali: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* 12-hour urine collection during the night (21h-9h) with the first urine in the morning collected separately * capillary blood samples (10 μL)

Study Officials

• Youssef Daali, Prof

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Youssef Daali

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 9, 2020
• Study Start: October 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

CH (1)