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 Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
dietary supplement is dosed at 1.9 mg of melatonin, 10 mg of zinc and 200 mg of lemon balm for one tablet
Cen Experimental
Dijon, France
Evolution of the plasma melatonin concentration
The change in plasma melatonin concentration
Time frame: Up to 720 minutes after taking the tablet
Plasma melatonin AUC
Area Under the Curve of plasma melatonin
Time frame: Up to 720 minutes after taking the tablet
Plasma melatonin Cmax
Peak concentration of plasma melatonin
Time frame: Up to 720 minutes after taking the tablet
Plasma melatonin Tmax
Time take to reach Cmax of plasma melatonin
Time frame: 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
Time frame: Up to 720 minutes after taking the tablet
Evolution of the plasma concentration of 6-sulfatoxymelatonin
The change in plasma 6-sulfatoxymelatonin concentration
Time frame: Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin AUC
Area Under the Curve of plasma 6-sulfatoxymelatonin
Time frame: Up to 720 minutes after taking the tablet
Plasma 6-sulfatoxymelatonin Cmax
Peak concentration of plasma 6-sulfatoxymelatonin
Time frame: Up to 720 minutes after taking the tablet
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Plasma 6-sulfatoxymelatonin Tmax
Time take to reach Cmax of plasma 6-sulfatoxymelatonin
Time frame: 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
Time frame: Up to 720 minutes after taking the tablet
Evolution of the plasma zinc concentration
The change in plasma zinc concentration
Time frame: Up to 720 minutes after taking the tablet
Plasma zinc AUC
Area Under the Curve of plasma zinc
Time frame: Up to 720 minutes after taking the tablet
Plasma zinc Cmax
Peak concentration of plasma zinc
Time frame: Up to 720 minutes after taking the tablet
Plasma zinc Tmax
Time take to reach Cmax of plasma zinc
Time frame: 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
Time frame: 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
Time frame: Up to 720 minutes after taking the tablet
Adverse events
Number and type of adverse events
Time frame: During study participation, maximum 45 days