Melatonin BioavailabilityNCT05419466
Kinetic of Compounds of a Melatonin-based Formulation in Healthy Subjects
A study testing dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm in people with Melatonin Bioavailability, run by Larena SAS at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Melatonin Bioavailability
- What is being tested?
- dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2023to 22 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Melatonin Bioavailability
- Being tested
- dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balmDietary supplement
dietary supplement is dosed at 1.9 mg of melatonin, 10 mg of zinc and 200 mg of lemon balm for one tablet
| Study group | Role | What they receive |
|---|---|---|
| melatonin and zinc bioavailability | Experimental | dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm Receives: Dietary Supplement: dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the plasma melatonin concentration
The change in plasma melatonin concentration
Measured: Up to 720 minutes after taking the tablet
Secondary outcomes (16)
Plasma melatonin AUC
Area Under the Curve of plasma melatonin
Measured: Up to 720 minutes after taking the tablet
Plasma melatonin Cmax
Peak concentration of plasma melatonin
Measured: Up to 720 minutes after taking the tablet
Plasma melatonin Tmax
Time take to reach Cmax of plasma melatonin
Measured: 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
Measured: Up to 720 minutes after taking the tablet
Evolution of the plasma concentration of 6-sulfatoxymelatonin
The change in plasma 6-sulfatoxymelatonin concentration
Measured: Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin AUC
Area Under the Curve of plasma 6-sulfatoxymelatonin
Measured: Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin Cmax
Peak concentration of plasma 6-sulfatoxymelatonin
Measured: Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin Tmax
Time take to reach Cmax of plasma 6-sulfatoxymelatonin
Measured: 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
Measured: Up to 720 minutes after taking the tablet
Evolution of the plasma zinc concentration
The change in plasma zinc concentration
Measured: Up to 720 minutes after taking the tablet
Plasma zinc AUC
Area Under the Curve of plasma zinc
Measured: Up to 720 minutes after taking the tablet
Plasma zinc Cmax
Peak concentration of plasma zinc
Measured: Up to 720 minutes after taking the tablet
Plasma zinc Tmax
Time take to reach Cmax of plasma zinc
Measured: 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
Measured: 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
Measured: Up to 720 minutes after taking the tablet
Adverse events
Number and type of adverse events
Measured: During study participation, maximum 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start14 Mar 2023
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melatonin BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larena SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno Claustrat, Study director, PiLeJe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419466
- Sponsor's protocol ID
- C1711
- Status last verified
- Nov 2023
- First submitted
- 3 Jun 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39174857
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetic of Plasmatic Compounds and Metabolites of a Melatonin-based Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05419466
- Acronym / sponsor ID
- C1711
- Conditions
- Melatonin Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Larena SASIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| melatonin and zinc bioavailability | Experimental | Dietary Supplement: dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balmdietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (22 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balmdietary supplement is dosed at 1.9 mg of melatonin, 10 mg of zinc and 200 mg of lemon balm for one tablet | Dietary supplement | melatonin and zinc bioavailability |
Primary outcome
Evolution of the plasma melatonin concentration
Time frame: Up to 720 minutes after taking the tablet
The change in plasma melatonin concentration
16 secondary outcomes
Plasma melatonin AUC
Time frame: Up to 720 minutes after taking the tablet
Plasma melatonin Cmax
Time frame: Up to 720 minutes after taking the tablet
Plasma melatonin Tmax
Time frame: Up to 720 minutes after taking the tablet
Plasma melatonin half life
Time frame: Up to 720 minutes after taking the tablet
Evolution of the plasma concentration of 6-sulfatoxymelatonin
Time frame: Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin AUC
Time frame: Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin Cmax
Time frame: Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin Tmax
Time frame: Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin half life
Time frame: Up to 720 minutes after taking the tablet
Evolution of the plasma zinc concentration
Time frame: Up to 720 minutes after taking the tablet
Plasma zinc AUC
Time frame: Up to 720 minutes after taking the tablet
Plasma zinc Cmax
Time frame: Up to 720 minutes after taking the tablet
Plasma zinc Tmax
Time frame: Up to 720 minutes after taking the tablet
Plasma zinc half life
Time frame: Up to 720 minutes after taking the tablet
Evolution of state of drowsiness
Time frame: Up to 720 minutes after taking the tablet
Adverse events
Time frame: During study participation, maximum 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 39174857Ait 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.
- Individual participant dataSharing planned: No
Related trials for Melatonin Bioavailability
Not yet recruitingPhase 3
Melatonin vs Midazolam in Children Undergoing Tonsillectomy
Emergence Delirium, Anesthesia, Child
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Claustrat study director
PiLeJe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm in people with Melatonin Bioavailability, run by Larena SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the plasma melatonin concentration (time frame: Up to 720 minutes after taking the tablet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05419466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.