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

Melatonin Bioavailability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574141
• Other study ID #: Pil-Clin-Melat-020
• Status: Completed
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: October 5, 2020

Study information

• Verified date: March 2021
• Source: Larena SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melatonin Bioavailability

Intervention

Dietary Supplement:
• a 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.

Locations

Country	Name	City	State
France	CIC CEN EXPERIMENTAL / CEN Nutriment	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
PiLeJe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evolution of the plasma melatonin concentration	the change in plasma melatonin concentration	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	evolution of the plasma concentration of 6-sulfatoxymelatonin	the change in plasma 6-sulfatoxymelatonin concentration	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	evolution of the urinary concentration of 6-sulfatoxymelatonin	the change in urinary 6-sulfatoxymelatonin concentration	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	evolution of the salivary concentration of melatonin	the change in salivary melatonin concentration	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	adverse events	adverse events	during study participation, maximum 45 days
Secondary	plasma melatonin AUC	Area Under the Curve of plasma melatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	plasma 6-sulfatoxymelatonin AUC	Area Under the Curve of plasma 6-sulfatoxymelatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	urinary 6-sulfatoxymelatonin AUC	Area Under the Curve of urinary 6-sulfatoxymelatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	salivary melatonin AUC	Area Under the Curve of salivary melatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	plasma melatonin Cmax	Peak concentration of plasma melatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	plasma 6-sulfatoxymelatonin Cmax	Peak concentration of plasma 6-sulfatoxymelatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	urinary 6-sulfatoxymelatonin Cmax	Peak concentration of urinary 6-sulfatoxymelatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	salivary melatonin Cmax	Peak concentration of salivary melatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	plasma melatonin Tmax	Time take to reach Cmax of plasma melatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	plasma 6-sulfatoxymelatonin Tmax	Time take to reach Cmax of plasma 6-sulfatoxymelatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	urinary 6-sulfatoxymelatonin Tmax	Time take to reach Cmax of urinary 6-sulfatoxymelatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	salivary melatonin Tmax	Time take to reach Cmax of salivary melatonin	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	plasma melatonin half life	time required for the concentration of plasma melatonin to decrease to half of its starting dose	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	plasma 6-sulfatoxymelatonin half life	time required for the concentration of plasma 6-sulfatoxymelatonin to decrease to half of its starting dose	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	urinary 6-sulfatoxymelatonin half life	time required for the concentration of urinary 6-sulfatoxymelatonin to decrease to half of its starting dose	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.
Secondary	salivary melatonin half life	time required for the concentration of salivary melatonin to decrease to half of its starting dose	over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.