Skip to main content
OpenTrials
Completed

NCT Number: NCT04574141

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CIC CEN EXPERIMENTAL / CEN Nutriment

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a prolonged release tablet and a spray containing melatonin

Dietary Supplement

prolonged release tablet is dosed at 1.9mg and spray is dosed at 1mg for 2 oral sprays.

Primary outcomes

  1. evolution of the plasma melatonin concentration

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    the change in plasma melatonin concentration

Secondary outcomes

  1. evolution of the plasma concentration of 6-sulfatoxymelatonin

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    the change in plasma 6-sulfatoxymelatonin concentration

  2. evolution of the urinary concentration of 6-sulfatoxymelatonin

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    the change in urinary 6-sulfatoxymelatonin concentration

  3. evolution of the salivary concentration of melatonin

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    the change in salivary melatonin concentration

  4. adverse events

    Time frame: during study participation, maximum 45 days

    adverse events

  5. plasma melatonin AUC

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    Area Under the Curve of plasma melatonin

  6. plasma 6-sulfatoxymelatonin AUC

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    Area Under the Curve of plasma 6-sulfatoxymelatonin

  7. urinary 6-sulfatoxymelatonin AUC

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    Area Under the Curve of urinary 6-sulfatoxymelatonin

  8. salivary melatonin AUC

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    Area Under the Curve of salivary melatonin

  9. plasma melatonin Cmax

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    Peak concentration of plasma melatonin

  10. plasma 6-sulfatoxymelatonin Cmax

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    Peak concentration of plasma 6-sulfatoxymelatonin

  11. urinary 6-sulfatoxymelatonin Cmax

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    Peak concentration of urinary 6-sulfatoxymelatonin

  12. salivary melatonin Cmax

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    Peak concentration of salivary melatonin

  13. plasma melatonin Tmax

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    Time take to reach Cmax of plasma melatonin

  14. plasma 6-sulfatoxymelatonin Tmax

    Time frame: 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

  15. urinary 6-sulfatoxymelatonin Tmax

    Time frame: 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

  16. salivary melatonin Tmax

    Time frame: over 540 minutes after taking the sustained-release tablet and 420 minutes after taking the spray.

    Time take to reach Cmax of salivary melatonin

  17. plasma melatonin half life

    Time frame: 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

  18. plasma 6-sulfatoxymelatonin half life

    Time frame: 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

  19. urinary 6-sulfatoxymelatonin half life

    Time frame: 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

  20. salivary melatonin half life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

PiLeJe

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2020
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.