Pharmacological Profile of Different Quercetin Formulations

Pharmacokinetics Clinical Trial

Official title:

Comparing the Pharmacological Profile of Different Quercetin Formulations in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05611827
• Other study ID #: 2021-03-002
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Factors Group of Nutritional Companies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65

• healthy, good physical condition

Exclusion Criteria:

• pregnancy or breast-feeding

• gastrointestinal conditions (acute or chronic)

• liver disease (acute or chronic)

• kidney disease (acute or chronic)

• cardiovascular disease (acute or chronic)

• hematological disease

• diabetes

• allergy or intolerance to gluten

• allergy or intolerance to quercetin

• use of any form of nicotine or tobacco, CBD/THC

• alcohol and substance abuse history

• use of medications (e.g., anti-inflammatory)

• use of quercetin supplements

• participation in another investigational study

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Dietary Supplement:
• Quercetin LipoMicel (250 mg)
Quercetin LipoMicel® soft-gels. Total dose of 250 mg of quercetin
• Quercetin LipoMicel (500 mg)
Quercetin LipoMicel® soft-gels. Total dose of 500 mg of quercetin
• Quercetin LipoMicel (1000 mg)
Quercetin LipoMicel® soft-gels. Total dose of 1000 mg of quercetin
• Regular/standard Quercetin (500 mg)
Total dose of 500 mg of quercetin

Locations

Country	Name	City	State
Canada	ISURA	Burnaby	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Factors Group of Nutritional Companies Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC: the area under the concentration-time curve	To evaluate the plasma uptake of orally ingested quercetin (aglycone) in a novel formulation ("LipoMicel") in healthy adults by comparing the Area under the concentration-time curve (AUC) with that of standard/regular quercetin (aglycone).	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Primary	Cmax: maximum plasma concentration	To evaluate the plasma uptake of orally ingested quercetin (aglycone) in a novel formulation ("LipoMicel") in healthy adults by comparing the Peak Plasma Concentration (Cmax) with that of standard/regular quercetin (aglycone).	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Primary	Tmax: the time point of maximum plasma concentration	To evaluate the plasma uptake of orally ingested quercetin (aglycone) in a novel formulation ("LipoMicel") in healthy adults by comparing the time point of maximum plasma concentration (Tmax) with that of standard/regular quercetin (aglycone).	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Secondary	AUC: the area under the concentration-time curve (quercetin metabolites)	To determine the plasma concentrations of quercetin metabolites following the oral consumption of LipoMicel® 250 mg, over a period of 72hrs, by calculating AUC.	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Secondary	Cmax: maximum plasma concentration (quercetin metabolites)	To determine the peak plasma concentrations of quercetin metabolites following the oral consumption of LipoMicel® 250 mg, over a period of 72hrs, by calculating Cmax.	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Secondary	Tmax: the time point of maximum plasma concentration (quercetin metabolites)	To determine the time point of maximum plasma concentration of quercetin metabolites following the oral consumption of LipoMicel® 250 mg, over a period of 72hrs, by calculating Tmax.	0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours