Pharmacokinetics
Conditions
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.
Interventions
DIETARY_SUPPLEMENTQuercetin LipoMicel (250 mg)
Quercetin LipoMicel® soft-gels. Total dose of 250 mg of quercetin
DIETARY_SUPPLEMENTQuercetin LipoMicel (500 mg)
Quercetin LipoMicel® soft-gels. Total dose of 500 mg of quercetin
DIETARY_SUPPLEMENTQuercetin LipoMicel (1000 mg)
Quercetin LipoMicel® soft-gels. Total dose of 1000 mg of quercetin
DIETARY_SUPPLEMENTRegular/standard Quercetin (500 mg)
Total dose of 500 mg of quercetin
Sponsors
Factors Group of Nutritional Companies Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC: the area under the concentration-time curve | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours | 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). |
| Cmax: maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours | 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). |
| Tmax: the time point of maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax: maximum plasma concentration (quercetin metabolites) | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours | 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. |
| Tmax: the time point of maximum plasma concentration (quercetin metabolites) | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours | 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. |
| AUC: the area under the concentration-time curve (quercetin metabolites) | 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours | To determine the plasma concentrations of quercetin metabolites following the oral consumption of LipoMicel® 250 mg, over a period of 72hrs, by calculating AUC. |
Countries
Canada
Outcome results
None listed