NCT05611827

Pharmacological Profile of Different Quercetin Formulations

Comparing the Pharmacological Profile of Different Quercetin Formulations in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Factors Group of Nutritional Companies Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the pharmacokinetics of quercetin in healthy participants after the administration of different formulations in a single- and multiple-dose phase. In the single-dose study, plasma uptake (AUC0-24 and Cmax) of standard quercetin is compared with that of LipoMicel®-a novel food-grade delivery form of quercetin. In the multiple dose study, accumulating plasma concentrations of formulated quercetin are observed over 72hrs, after repeated doses of LipoMicel treatments (AUC0-72). At least ten healthy adults participate in an open-label, diet-controlled, crossover, plasma uptake study. Participants receive three different doses (250 mg, 500 mg or 1000 mg) of quercetin aglycone orally.

Detailed description

Objective of this study is to investigate the pharmacokinetic profile of formulated quercetin (LipoMicel®), administered at three different doses, in healthy participants and compare it with that of a standard formulation. The pharmacokinetics of the different quercetin treatments are observed over 24hrs after a single orally administered dose of quercetin (e.g., using AUC0-24 and Cmax). Furthermore, the accumulating plasma concentrations of formulated quercetin are monitored over a 72hr period (e.g., using AUC0-72), following multiple orally administered doses of LipoMicel treatments (250 mg-1000 mg) plus the circulating metabolites of quercetin are determined in the human plasma.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Quercetin LipoMicel (250 mg)	Quercetin LipoMicel® soft-gels. Total dose of 250 mg of quercetin
DIETARY_SUPPLEMENT	Quercetin LipoMicel (500 mg)	Quercetin LipoMicel® soft-gels. Total dose of 500 mg of quercetin
DIETARY_SUPPLEMENT	Quercetin LipoMicel (1000 mg)	Quercetin LipoMicel® soft-gels. Total dose of 1000 mg of quercetin
DIETARY_SUPPLEMENT	Regular/standard Quercetin (500 mg)	Total dose of 500 mg of quercetin

Timeline

• Start date: 2022-01-31
• Primary completion: 2022-07-31
• Completion: 2022-10-31
• First posted: 2022-11-10
• Last updated: 2022-11-10

Locations

1 site across 1 country: Canada