NCT05835258

Oral Bioavailability of Two Melatonin Supplements

Interventional Study for the Comparison of the Oral Bioavailability of Two Melatonin Supplements

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Fundació Eurecat · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: * Maximum plasma concentration (Cmax). * Time for maximum plasma concentration (Tmax). * Half-life (T1/2). * Area Under the Curve (AUC 0-inf) of plasma melatonin levels 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).

Conditions

• Bioavailability

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melatonin with phenyl capsaicin	Blood samples will be collected at different time points following the oral administration of the melatonin supplement with 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 without phenyl capsaicin

Timeline

• Start date: 2023-05-30
• Primary completion: 2023-07-14
• Completion: 2023-07-14
• First posted: 2023-04-28
• Last updated: 2023-08-01

Locations

1 site across 1 country: Spain