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

NCT05419466 | Completed

• 1 other identifier: C1711
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evolution of the plasma melatonin concentration

  The change in plasma melatonin concentration

  Up to 720 minutes after taking the tablet

Secondary Outcomes (16)

• Plasma melatonin AUC

  Up to 720 minutes after taking the tablet

• Plasma melatonin Cmax

  Up to 720 minutes after taking the tablet

• Plasma melatonin Tmax

  Up to 720 minutes after taking the tablet

• Plasma melatonin half life

  Up to 720 minutes after taking the tablet

• Evolution of the plasma concentration of 6-sulfatoxymelatonin

  Up to 720 minutes after taking the tablet

Study Arms (1)

melatonin and zinc bioavailability

EXPERIMENTAL

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

Interventions

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

melatonin and zinc bioavailability

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,
• 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 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,
• 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,

Sponsors & Collaborators

• Larena SAS: lead

Study Sites (1)

Cen Experimental

Dijon, 21000, France

Location

Related Publications (1)

• 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.

  PMID: 39174857 DERIVED

MeSH Terms

Interventions

Dietary Supplements; Zinc

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Bruno Claustrat

  PiLeJe

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 15, 2022
• Study Start: March 14, 2023
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)