Kinetic of Melatonin Subsequent to the Consumption of Melatonin-rich Food Supplements

PiLeJe

Status

Completed

Conditions

Melatonin Bioavailability

Treatments

Dietary Supplement: a prolonged release tablet and a spray containing melatonin

Study type

Interventional

Funder types

Industry

Identifiers

NCT04574141

Pil-Clin-Melat-020

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.