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OpenTrials
Completed

NCT Number: NCT05611827

Pharmacological Profile of Different Quercetin Formulations

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ISURA

Burnaby, British Columbia, V3N4S9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quercetin LipoMicel (250 mg)

Dietary Supplement

Quercetin LipoMicel® soft-gels. Total dose of 250 mg of quercetin

Quercetin LipoMicel (500 mg)

Dietary Supplement

Quercetin LipoMicel® soft-gels. Total dose of 500 mg of quercetin

Quercetin LipoMicel (1000 mg)

Dietary Supplement

Quercetin LipoMicel® soft-gels. Total dose of 1000 mg of quercetin

Regular/standard Quercetin (500 mg)

Dietary Supplement

Total dose of 500 mg of quercetin

Primary outcomes

  1. AUC: the area under the concentration-time curve

    Time frame: 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).

  2. Cmax: maximum plasma concentration

    Time frame: 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).

  3. Tmax: the time point of maximum plasma concentration

    Time frame: 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 outcomes

  1. AUC: the area under the concentration-time curve (quercetin metabolites)

    Time frame: 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.

  2. Cmax: maximum plasma concentration (quercetin metabolites)

    Time frame: 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.

  3. Tmax: the time point of maximum plasma concentration (quercetin metabolites)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Factors Group of Nutritional Companies Inc.

Industry

Registry information

Official study title

Comparing the Pharmacological Profile of Different Quercetin Formulations in Healthy Volunteers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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