Clinical trial NCT05611827: Pharmacological Profile of Different Quercetin Formulations
Official title: Comparing the Pharmacological Profile of Different Quercetin Formulations in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacokinetics
Lead sponsor: Factors Group of Nutritional Companies Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: AUC: the area under the concentration-time curve
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
measure: Cmax: maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
measure: Tmax: the time point of maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Secondary outcomes:
measure: AUC: the area under the concentration-time curve (quercetin metabolites)
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
measure: Cmax: maximum plasma concentration (quercetin metabolites)
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
measure: Tmax: the time point of maximum plasma concentration (quercetin metabolites)
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: ISURA
state: British Columbia
Study officials:
References: