HealthyMelaCYPNCT04420611
Use of Endogenous Melatonin and 6-hydroxymelatonin as Biomarkers for CYP1A2
An observational study of Healthy, run by Youssef Daali at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Session 1 (day 1), Session 2 (day 3) and Session 3 (day 15)
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy men and women
Who may be able to join
- Healthy men and women
- Understanding of French language and ability to give a written informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Session 1 (day 1), Session 2 (day 3), Session 3 (day 15), Session 4 (day 30)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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®.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (4)
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)
Measured: 3 days (day 1, day 4 and day 30)
Urine correlation
Assess correlation between 12 hours overnight urine and first morning voids samples
Measured: 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)
Measured: 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)
Measured: 1 day (day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Oct 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Youssef Daali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Youssef Daali, University Hospital, Geneva
- Investigators
- Youssef Daali, Prof, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420611
- Sponsor's protocol ID
- 2020-00125
- Acronym
- MelaCYP
- Status last verified
- May 2023
- First submitted
- 19 May 2020
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Endogenous Melatonin and 6-hydroxymelatonin as Biomarkers for CYP1A2
- ClinicalTrials.gov ID
- NCT04420611
- Acronym / sponsor ID
- MelaCYP / 2020-00125
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Youssef DaaliUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy men and women
Key inclusion criteria (2 listed)
- Healthy men and women
- Understanding of French language and ability to give a written informed consent
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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®. | Other | – |
| 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®. | Other | – |
| 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®. | Other | – |
| 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®. | Other | – |
Primary outcome
Validation LC-MS/MS analytical method
Time frame: 1 month
Validation of the LC-MS/MS analytical method for simultaneous quantification of endogenous melatonin and 6-hydroxymelatonin in urine samples
4 secondary outcomes
Intra- and inter-variability
Time frame: 3 days (day 1, day 4 and day 30)
Urine correlation
Time frame: 4 days (day 1, day 4, day 15 and day 30)
Correlation melatonin and caffeine
Time frame: 4 days (day 1, day 4, day 15 and day 30)
Impact caffeine intake
Time frame: 1 day (day 15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youssef Daali, Prof principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Youssef Daali at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation LC-MS/MS analytical method (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.