Melatonin Bioavailability
Conditions
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.
Interventions
DIETARY_SUPPLEMENTa prolonged release tablet and a spray containing melatonin
prolonged release tablet is dosed at 1.9mg and spray is dosed at 1mg for 2 oral sprays.
Sponsors
PiLeJe
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evolution of the plasma melatonin concentration | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | the change in plasma melatonin concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evolution of the plasma concentration of 6-sulfatoxymelatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | the change in plasma 6-sulfatoxymelatonin concentration |
| evolution of the salivary concentration of melatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | the change in salivary melatonin concentration |
| evolution of the urinary concentration of 6-sulfatoxymelatonin | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | the change in urinary 6-sulfatoxymelatonin concentration |
| plasma melatonin AUC | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Area Under the Curve of plasma melatonin |
| plasma 6-sulfatoxymelatonin AUC | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Area Under the Curve of plasma 6-sulfatoxymelatonin |
| urinary 6-sulfatoxymelatonin AUC | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Area Under the Curve of urinary 6-sulfatoxymelatonin |
| salivary melatonin AUC | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Area Under the Curve of salivary melatonin |
| plasma melatonin Cmax | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Peak concentration of plasma melatonin |
| plasma 6-sulfatoxymelatonin Cmax | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Peak concentration of plasma 6-sulfatoxymelatonin |
| adverse events | during study participation, maximum 45 days | adverse events |
| salivary melatonin Cmax | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Peak concentration of salivary melatonin |
| plasma melatonin Tmax | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Time take to reach Cmax of plasma melatonin |
| plasma 6-sulfatoxymelatonin Tmax | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Time take to reach Cmax of plasma 6-sulfatoxymelatonin |
| urinary 6-sulfatoxymelatonin Tmax | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Time take to reach Cmax of urinary 6-sulfatoxymelatonin |
| salivary melatonin Tmax | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Time take to reach Cmax of salivary melatonin |
| plasma melatonin half life | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | time required for the concentration of plasma melatonin to decrease to half of its starting dose |
| plasma 6-sulfatoxymelatonin half life | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | time required for the concentration of plasma 6-sulfatoxymelatonin to decrease to half of its starting dose |
| urinary 6-sulfatoxymelatonin half life | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | time required for the concentration of urinary 6-sulfatoxymelatonin to decrease to half of its starting dose |
| salivary melatonin half life | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | time required for the concentration of salivary melatonin to decrease to half of its starting dose |
| urinary 6-sulfatoxymelatonin Cmax | over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. | Peak concentration of urinary 6-sulfatoxymelatonin |
Countries
France
Outcome results
None listed