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

NCT04574141 | Completed

• 1 other identifier: Pil-Clin-Melat-020
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Melatonin Bioavailability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• evolution of the plasma concentration of 6-sulfatoxymelatonin

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

• evolution of the urinary concentration of 6-sulfatoxymelatonin

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

• evolution of the salivary concentration of melatonin

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

• adverse events

  during study participation, maximum 45 days

• plasma melatonin AUC

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

Study Arms (2)

spray before tablet

EXPERIMENTAL

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

tablet before spray

EXPERIMENTAL

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

Interventions

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.

spray before tablet; tablet before spray

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male between the ages of 18 and 45,
• 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.

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• PiLeJe: lead

Study Sites (1)

CIC CEN EXPERIMENTAL / CEN Nutriment

Dijon, 21000, France

Location

Related Publications (1)

• Ait Abdellah S, Raverot V, Gal C, Guinobert I, Bardot V, Blondeau C, Claustrat B. Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers. Drugs R D. 2023 Sep;23(3):257-265. doi: 10.1007/s40268-023-00431-9. Epub 2023 Jul 12.

  PMID: 37438493 DERIVED

Study Officials

• Bruno Claustrat

  PiLeJe

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: October 5, 2020
• Study Start: July 13, 2020
• Primary Completion: October 5, 2020
• Study Completion: October 5, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)