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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| melatonin and zinc bioavailability | Experimental | dietary supplement, 1 tablet containing delayed release melatonin, zinc and lemon balm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the plasma melatonin concentration | The change in plasma melatonin concentration | Up to 720 minutes after taking the tablet |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Claustrat | PiLeJe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cen Experimental | Dijon | 21000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39174857 | Derived | 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. |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D015032 | Zinc |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| 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 |
| D019216 |
| Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |