NCT05611827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

November 3, 2022

Last Update Submit

November 3, 2022

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (4)

Quercetin LipoMicel (250 mg)

EXPERIMENTAL

Each participant receives their treatment of Quercetin LipoMicel at a total dose of 250 mg quercetin. Treatments are consumed with a glass of water (approx. 200 mL), but with no food (4hr fasting condition). Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24hrs following a single-dose administration of quercetin and at 25, 47, 48, 71 and 72hrs after a repeated oral total dose of 250 mg LipoMicel (once daily for 72hrs). A washout period of at least 7 days between each treatment will be used.

Dietary Supplement: Quercetin LipoMicel (250 mg)

Quercetin LipoMicel (500 mg)

EXPERIMENTAL

Each participant receives their treatment of Quercetin LipoMicel at a total dose of 500 mg quercetin. Treatments are consumed with a glass of water (approx. 200 mL), but with no food (4hr fasting condition). Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24hrs following a single-dose administration of quercetin and at 25, 47, 48, 71 and 72hrs after a repeated oral total dose of 500 mg LipoMicel (once daily for 72hrs). A washout period of at least 7 days between each treatment will be used.

Dietary Supplement: Quercetin LipoMicel (500 mg)

Quercetin LipoMicel (1000 mg)

EXPERIMENTAL

Each participant receives their treatment of Quercetin LipoMicel at a total dose of 1000 mg quercetin. Treatments are consumed with a glass of water (approx. 200 mL), but with no food (4hr fasting condition). Capillary whole blood samples are collected at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24hrs following a single-dose administration of quercetin and at 25, 47, 48, 71 and 72hrs after a repeated oral total dose of 1000 mg LipoMicel (once daily for 72hrs). A washout period of at least 7 days between each treatment will be used.

Dietary Supplement: Quercetin LipoMicel (1000 mg)

Regular/standard Quercetin (500 mg)

EXPERIMENTAL

Each participant receives their treatment of standard/raw Quercetin at a total dose of 500 mg quercetin. Treatments are consumed with a glass of water (approx. 200 mL), but with no food (4hr fasting condition). A standardized lunch and dinner are served after 4h and 8h of product administration. Capillary whole blood samples are collected (after a 10hr overnight fast) at time points 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24hrs following a single-dose administration of quercetin. A washout period of at least 7 days between each treatment will be used.

Dietary Supplement: Regular/standard Quercetin (500 mg)

Interventions

Quercetin LipoMicel (250 mg)DIETARY_SUPPLEMENT

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

Quercetin LipoMicel (250 mg)
Quercetin LipoMicel (500 mg)DIETARY_SUPPLEMENT

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

Quercetin LipoMicel (500 mg)
Quercetin LipoMicel (1000 mg)DIETARY_SUPPLEMENT

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

Quercetin LipoMicel (1000 mg)
Regular/standard Quercetin (500 mg)DIETARY_SUPPLEMENT

Total dose of 500 mg of quercetin

Regular/standard Quercetin (500 mg)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-65
  • healthy, good physical condition

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISURA

Burnaby, British Columbia, V3N4S9, Canada

Location

Related Publications (1)

  • Solnier J, Zhang Y, Roh K, Kuo YC, Du M, Wood S, Hardy M, Gahler RJ, Chang C. A Pharmacokinetic Study of Different Quercetin Formulations in Healthy Participants: A Diet-Controlled, Crossover, Single- and Multiple-Dose Pilot Study. Evid Based Complement Alternat Med. 2023 Aug 10;2023:9727539. doi: 10.1155/2023/9727539. eCollection 2023.

    PMID: 37600550DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 10, 2022

Study Start

January 31, 2022

Primary Completion

July 31, 2022

Study Completion

October 31, 2022

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)