Clinical trial NCT04574141: Kinetic of Melatonin Subsequent to the Consumption of Melatonin-rich Food Supplements
Official title: Randomized, Open-label Bioavailability Study of the Kinetics of Plasma, Urinary and Salivary Concentrations of Melatonin and 6-sulfatoxymelatonin Subsequent to the Consumption of Melatonin-rich Food Supplements With Different Galenic Forms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melatonin Bioavailability
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays.


Eligibility criteria: Inclusion Criteria:

* Male between the ages of 18 and 45,
* In good general health, i.e., free of chronic conditions and not taking medication at the time of inclusion and/or long-term,
* Over 70 kg and with a body mass index between 18.5 and 24.9,
* Able and willing to participate in the research by complying with the procedures of the protocol, in particular concerning the taking of the product under study and the performance of sequential blood tests,
* Having freely signed the consent form after adequate information on the proposed study, in accordance with Good Clinical Practice and after submission of the information leaflet,
* Affiliated to a social security scheme or similar.

Exclusion Criteria:

* Smoker,
* Drug addict,
* Subject with an alcohol consumption of more than 2 glasses per day,
* Taking a drug treatment or melatonin or a product containing melatonin within 48 hours prior to a kinetics visit,
* Known organic or functional abnormality of the urinary tree,
* Any medical condition that would involve a change in melatonin metabolism:

Drug intake: Fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, carbamazepine and rifampicin, analgesics, Liver abnormality known or detected at the screening visit and judged to be clinically significant by the investigator, Known autoimmune disease,

* Subject assessed as "moderately" or "definitely" evening type,
* Known hypertension (\>140/90),
* Diagnosis of migraine by a health professional according to the International Headache Society (IHS) criteria revised in 2004,
* Wuth a sleep disorder,
* Thyroid dysfunction, hyperglycemia or anemia judged to be clinically significant by the investigator,
* Blood donation within one month prior to inclusion,
* A known organic or psychological abnormality (including a history of severe depression) that may bias the results of the study as judged by the investigator,
* Workers with atypical working hours (night work, staggered working hours),
* Known allergy or intolerance to any of the components of the product,
* Psychological or linguistic inability to understand and sign informed consent,
* Participant in another interventional clinical trial or during a period of exclusion from a previous clinical trial,
* Under legal protection (guardianship, curatorship) or deprived of his rights as a result of the administrative or judicial decision,
* Subject who has reached the maximum threshold for compensation for research provided for in the regulations.

Primary outcomes:
measure: evolution of the plasma melatonin concentration
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary outcomes:
measure: evolution of the plasma concentration of 6-sulfatoxymelatonin
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: evolution of the urinary concentration of 6-sulfatoxymelatonin
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: evolution of the salivary concentration of melatonin
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: adverse events
timeFrame: during study participation, maximum 45 days
measure: plasma melatonin AUC
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: plasma 6-sulfatoxymelatonin AUC
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: urinary 6-sulfatoxymelatonin AUC
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: salivary melatonin AUC
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: plasma melatonin Cmax
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: plasma 6-sulfatoxymelatonin Cmax
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: urinary 6-sulfatoxymelatonin Cmax
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: salivary melatonin Cmax
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: plasma melatonin Tmax
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: plasma 6-sulfatoxymelatonin Tmax
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: urinary 6-sulfatoxymelatonin Tmax
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: salivary melatonin Tmax
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: plasma melatonin half life
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: plasma 6-sulfatoxymelatonin half life
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: urinary 6-sulfatoxymelatonin half life
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
measure: salivary melatonin half life
timeFrame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Other outcomes:
Locations:
city: Dijon
country: France
facility: CIC CEN EXPERIMENTAL / CEN Nutriment
Study officials:
affiliation: PiLeJe
name: Bruno Claustrat
role: STUDY_DIRECTOR
References: