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Pharmacological Profile of Different Quercetin Formulations

NCT05611827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-11-10

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics

Interventions

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

Sponsors & Collaborators

  • Factors Group of Nutritional Companies Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-07-31
Completion
2022-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05611827 on ClinicalTrials.gov