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

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

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

Conditions
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Melatonin Bioavailability

Intervention / Treatment
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* Dietary Supplement: dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: melatonin and zinc bioavailability<br>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<br>* dietary supplement is dosed at 1.9 mg of melatonin, 10 mg of zinc and 200 mg of lemon balm for one tablet<br>|

What is the study measuring?
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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 |