Kinetic of Melatonin Subsequent to the Consumption of Melatonin-rich Food Supplements
- Conditions
- Melatonin Bioavailability
- Interventions
- Dietary Supplement: a prolonged release tablet and a spray containing melatonin
- Registration Number
- NCT04574141
- Lead Sponsor
- PiLeJe
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description tablet before spray a prolonged release tablet and a spray containing melatonin - spray before tablet a prolonged release tablet and a spray containing melatonin -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method adverse events during study participation, maximum 45 days adverse events
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
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
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
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 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
salivary melatonin Cmax over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray. Peak concentration of salivary melatonin
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
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
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 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
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
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 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 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
Trial Locations
- Locations (1)
CIC CEN EXPERIMENTAL / CEN Nutriment
š«š·Dijon, France