An interventional study of Melatonin with phenyl capsaicin and Melatonin without phenyl capsaicin in Bioavailability, sponsored by Fundació Eurecat. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Fundació Eurecat · Not applicable, Interventional, and Other
Results from several clinical studies show that orally administered melatonin has low bioavailability and a very short half-life. Phenyl capsaicin, a synthetic analogue of capsaicin, might increase its bioavailability by inhibiting the enzymes involved in its hepatic metabolism.
Thus, the hypothesis of the present study is that the administration of melatonin supplement with phenyl capsaicin presents greater bioavailability than a melatonin supplement that does not contain phenyl capsaicin.
Melatonin is an endogenous indolamine that regulates many physiological functions such as reproduction, temperature, mood, bone growth or the immune system. However, since its production is closely related to the light/dark cycle, melatonin is considered one of the main chronobiotic agents that modulates circadian rhythms.
For this reason, in recent years there has been increased interest in the exogenous use of melatonin to address problems of insomnia and circadian rhythm disorders such as jet lag syndrome or shift work. Although many studies have demonstrated the effectiveness of melatonin in treating sleep disorders, pharmacokinetic studies show that it has poor oral bioavailability and a very short half-life. So, new strategies and studies are necessary to increase the low bioavailability of melatonin.
In this context, it has been shown that phenyl capsaicin, a synthetic analogue of capsaicin, might increase melatonin's bioavailability by inhibiting Cytochrome P450 liver enzymes, which are involved in its metabolism. Therefore, the main objective of this study is to quantify and compare the oral bioavailability between a melatonin supplement with phenyl capsaicin and another melatonin supplement that does not contain phenyl capsaicin.
The secondary objectives of the study are to determine the pharmacokinetic parameters:
During the study there will be 3 visits: a preselection visit (V0), a visit for the first postprandial study (V1) and after one week washing period, a visit for the second postprandial study (V2).
Fundació Eurecat is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will consume one capsule of 1 mg of melatonin with phenyl capsaicin
Dietary Supplement: Melatonin with phenyl capsaicin
Participants will consume one capsule of 1 mg of melatonin without phenyl capsaicin
Dietary Supplement: Melatonin without phenyl capsaicin
Blood samples will be collected at different time points following the oral administration of the melatonin supplement with phenyl capsaicin
Blood samples will be collected at different time points following the oral administration of the melatonin supplement without phenyl capsaicin
Bioavailability of melatonin calculated by the Area Under The Curve (AUC 0-6) of plasma melatonin levels
Fasting melatonin levels in plasma will be determined before consuming the melatonin supplement until 6 hours postprandially at 7 points after consuming the capsule (15 min., 30 min., 45 min., 1h., 2h., 4h and 6h). The melatonin levels in plasma will be quantified by Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS)
Time frame: At week 1
Bioavailability of melatonin calculated by the Area Under The Curve (AUC 0-6) of plasma melatonin levels
Fasting melatonin levels in plasma will be determined before consuming the melatonin supplement until 6 hours postprandially at 7 points after consuming the capsule (15 min., 30 min., 45 min., 1h., 2h., 4h and 6h). The melatonin levels in plasma will be quantified by Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS)
Time frame: At week 3
Maximum plasma concentration (Cmax)
Maximum plasma concentration of melatonin
Time frame: At week 1
Maximum plasma concentration (Cmax)
Maximum plasma concentration of melatonin
Time frame: At week 3
Time for maximum plasma concentration (Tmax)
Time period for the maximum plasma concentration of melatonin
Time frame: At week 1
Time for maximum plasma concentration (Tmax)
Time period for the maximum plasma concentration of melatonin
Time frame: At week 3
Half-life (T1/2)
Time taken for half the initial dose of melatonin administered to be eliminated from the body
Time frame: At week 1
Half-life (T1/2)
Time taken for half the initial dose of melatonin administered to be eliminated from the body
Time frame: At week 3
Area Under the Curve (AUC 0-inf) to infinite time of plasma melatonin levels
AUC 0-inf extrapolates the area to infinite time and measures the total melatonin exposure across time.
Time frame: At week 1
Area Under the Curve (AUC 0-inf) to infinite time of plasma melatonin levels
AUC 0-inf extrapolates the area to infinite time and measures the total melatonin exposure across time.
Time frame: At week 3
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Fundació Eurecat