Kinetic of Compounds of a Melatonin-based Formulation in Healthy Subjects

Kinetic of Plasmatic Compounds and Metabolites of a Melatonin-based Formulation in Healthy Subjects

This study is conducted to clinically document the melatonin and zinc bioavailability of a dietary supplement containing delayed release melatonin, zinc and lemon balm

Study Overview

• Status: Recruiting
• Conditions: Melatonin Bioavailability
• Intervention / Treatment: Dietary supplement: dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Cen Experimental
    • Contact: Carole PERRIN; Phone Number: 03 80 68 05 05

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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,
• 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 zinc or a product containing it 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, rifampicin, analgesics, Liver abnormality known or detected at the screening visit and judged to be clinically significant by the investigator, Known autoimmune disease,
• Any condition that could involve zinc deficiency or hyperzincemia: Medication intake: penicillamine or diuretics, Poisoning by exposure to zinc (zinc mines, zinc metallurgy, galvanizing operations, manufacture of alloys, use of zinc-based pigments and salts, etc.), Pick's disease, malabsorption (pancreatic insufficiency, biliary obstruction, gastrectomy, jejuno-ileostomy, intestinal diverticulum, tropical sprue, celiac disease, cystic fibrosis), intestinal inflammation (enteropathy with protein leakage, inflammatory colitis), liver disorders (cirrhosis, hepatitis) , kidney disorders (chronic renal failure, nephrotic syndrome), neuropsychiatric disorders (anorexia nervosa, endogenous depression, alcoholism), genetic diseases (acrodermatitis enteropathica, thalassemia, sickle cell disease, diabetes, trisomy 21, phenylketonuria), parasitic diseases (ankylostomiasis, schistosomiasis, malaria , giardiasis)
• Subject assessed as "rather" or "definitely" among evening people,
• Epileptic subject,
• Asthmatic subject,
• Known hypertension (>140/90),
• Diagnosis of migraine by a health professional according to the International Headache Society (IHS) criteria revised in 2004,
• With 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: melatonin and zinc bioavailability; dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm	Dietary supplement: dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm; dietary supplement is dosed at 1.9 mg of melatonin, 10 mg of zinc and 200 mg of lemon balm for one tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the plasma melatonin concentration	The change in plasma melatonin concentration	Up to 720 minutes after taking the tablet

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma melatonin AUC	Area Under the Curve of plasma melatonin	Up to 720 minutes after taking the tablet
Plasma melatonin Cmax	Peak concentration of plasma melatonin	Up to 720 minutes after taking the tablet
Plasma melatonin Tmax	Time take to reach Cmax of plasma melatonin	Up to 720 minutes after taking the tablet
Plasma melatonin half life	Time required for the concentration of plasma melatonin to decrease to half of its starting dose	Up to 720 minutes after taking the tablet
Evolution of the plasma concentration of 6-sulfatoxymelatonin	The change in plasma 6-sulfatoxymelatonin concentration	Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin AUC	Area Under the Curve of plasma 6-sulfatoxymelatonin	Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin Cmax	Peak concentration of plasma 6-sulfatoxymelatonin	Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin Tmax	Time take to reach Cmax of plasma 6-sulfatoxymelatonin	Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin half life	Time required for the concentration of plasma 6-sulfatoxymelatonin to decrease to half of its starting dose	Up to 720 minutes after taking the tablet
Evolution of the plasma zinc concentration	The change in plasma zinc concentration	Up to 720 minutes after taking the tablet
Plasma zinc AUC	Area Under the Curve of plasma zinc	Up to 720 minutes after taking the tablet
Plasma zinc Cmax	Peak concentration of plasma zinc	Up to 720 minutes after taking the tablet
Plasma zinc Tmax	Time take to reach Cmax of plasma zinc	Up to 720 minutes after taking the tablet
Plasma zinc half life	Time required for the concentration of plasma zinc to decrease to half of its starting dose	Up to 720 minutes after taking the tablet
Evolution of state of drowsiness	The change in (Visual Analog Scale)VAS score, minimum = 0 and maximum = 10 higher score means a worse outcome	Up to 720 minutes after taking the tablet
Adverse events	Number and type of adverse events	During study participation, maximum 45 days

Collaborators and Investigators

• Sponsor: Larena SAS

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: C1711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No