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

NCT ID: NCT05419466

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2023-05-22

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

Conditions

Melatonin Bioavailability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

melatonin and zinc bioavailability

dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm

Group Type: EXPERIMENTAL

dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm

Intervention Type: DIETARY_SUPPLEMENT

dietary supplement is dosed at 1.9 mg of melatonin, 10 mg of zinc and 200 mg of lemon balm for one tablet

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Larena SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Claustrat

Role: STUDY_DIRECTOR

PiLeJe

Locations

Cen Experimental

Dijon, , France

Countries

France

References

Ait Abdellah S, Gal C, Guinobert I, Bardot V, Raverot V, Vitacca A, Blondeau C, Claustrat B. Melatonin Bioavailability After Oral Administration of a New Delayed-Release Form in Healthy Male Volunteers. Drugs R D. 2024 Sep;24(3):415-423. doi: 10.1007/s40268-024-00482-6. Epub 2024 Aug 22.

Reference Type: DERIVED

PMID: 39174857 (View on PubMed)

Other Identifiers

C1711

Identifier Type: -

Identifier Source: org_study_id