Pharmacological Profile of Different Quercetin Formulations

NCT ID: NCT05611827

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-10-31

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.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quercetin LipoMicel (250 mg)

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.

Group Type: EXPERIMENTAL

Quercetin LipoMicel (250 mg)

Intervention Type: DIETARY_SUPPLEMENT

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

Quercetin LipoMicel (500 mg)

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.

Group Type: EXPERIMENTAL

Quercetin LipoMicel (500 mg)

Intervention Type: DIETARY_SUPPLEMENT

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

Quercetin LipoMicel (1000 mg)

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.

Group Type: EXPERIMENTAL

Quercetin LipoMicel (1000 mg)

Intervention Type: DIETARY_SUPPLEMENT

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

Regular/standard Quercetin (500 mg)

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.

Group Type: EXPERIMENTAL

Regular/standard Quercetin (500 mg)

Intervention Type: DIETARY_SUPPLEMENT

Total dose of 500 mg of quercetin

Interventions

Quercetin LipoMicel (250 mg)

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

Intervention Type: DIETARY_SUPPLEMENT

Quercetin LipoMicel (500 mg)

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

Intervention Type: DIETARY_SUPPLEMENT

Quercetin LipoMicel (1000 mg)

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

Intervention Type: DIETARY_SUPPLEMENT

Regular/standard Quercetin (500 mg)

Total dose of 500 mg of quercetin

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Factors Group of Nutritional Companies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ISURA

Burnaby, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37600550 (View on PubMed)

Other Identifiers

2021-03-002

Identifier Type: -

Identifier Source: org_study_id