Clinical trial NCT05419466: Kinetic of Compounds of a Melatonin-based Formulation in Healthy Subjects
Official title: Kinetic of Plasmatic Compounds and Metabolites of a Melatonin-based Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melatonin Bioavailability
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
First posted: 2022-06-15
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Evolution of the plasma melatonin concentration
timeFrame: Up to 720 minutes after taking the tablet
Secondary outcomes:
measure: Plasma melatonin AUC
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma melatonin Cmax
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma melatonin Tmax
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma melatonin half life
timeFrame: Up to 720 minutes after taking the tablet
measure: Evolution of the plasma concentration of 6-sulfatoxymelatonin
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma 6-sulfatoxymelatonin AUC
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma 6-sulfatoxymelatonin Cmax
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma 6-sulfatoxymelatonin Tmax
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma 6-sulfatoxymelatonin half life
timeFrame: Up to 720 minutes after taking the tablet
measure: Evolution of the plasma zinc concentration
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma zinc AUC
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma zinc Cmax
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma zinc Tmax
timeFrame: Up to 720 minutes after taking the tablet
measure: Plasma zinc half life
timeFrame: Up to 720 minutes after taking the tablet
measure: Evolution of state of drowsiness
timeFrame: Up to 720 minutes after taking the tablet
measure: Adverse events
timeFrame: During study participation, maximum 45 days
Other outcomes:
Locations:
city: Dijon
country: France
facility: Cen Experimental
Study officials:
affiliation: PiLeJe
name: Bruno Claustrat
role: STUDY_DIRECTOR
References: