PharmacokineticsNCT05611827
Pharmacological Profile of Different Quercetin Formulations
A study testing Quercetin LipoMicel (250 mg), Quercetin LipoMicel (500 mg) and Quercetin LipoMicel (1000 mg) in people with Pharmacokinetics, run by Factors Group of Nutritional Companies Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Quercetin LipoMicel (250 mg), Quercetin LipoMicel (500 mg) and Quercetin LipoMicel (1000 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jan 2022to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-65
- healthy, good physical condition
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Pharmacological Profile of Different Quercetin Formulations in Healthy Volunteers
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.
Read the 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
- Being tested
- Quercetin LipoMicel (250 mg), Quercetin LipoMicel (500 mg), Quercetin LipoMicel (1000 mg), Regular/standard Quercetin (500 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Regular/standard Quercetin (500 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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)
To determine the plasma concentrations of quercetin metabolites following the oral consumption of LipoMicel® 250 mg, over a period of 72hrs, by calculating AUC.
Measured: 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)
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.
Measured: 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)
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.
Measured: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start31 Jan 2022
- Primary completion31 Jul 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Factors Group of Nutritional Companies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611827
- Sponsor's protocol ID
- 2021-03-002
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37600550
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Pharmacological Profile of Different Quercetin Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05611827
- Acronym / sponsor ID
- 2021-03-002
- Conditions
- Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Factors Group of Nutritional Companies Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Quercetin LipoMicel (250 mg) | Experimental | Dietary Supplement: 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. |
| Quercetin LipoMicel (500 mg) | Experimental | Dietary Supplement: 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. |
| Quercetin LipoMicel (1000 mg) | Experimental | Dietary Supplement: 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. |
| Regular/standard Quercetin (500 mg) | Experimental | Dietary Supplement: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-65
- healthy, good physical condition
Key exclusion criteria (14 listed)
- pregnancy or breast-feeding
- gastrointestinal conditions (acute or chronic)
- liver disease (acute or chronic)
- kidney disease (acute or chronic)
- cardiovascular disease (acute or chronic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quercetin LipoMicel (250 mg)Quercetin LipoMicel® soft-gels. Total dose of 250 mg of quercetin | Dietary supplement | Quercetin LipoMicel (250 mg) |
| Quercetin LipoMicel (500 mg)Quercetin LipoMicel® soft-gels. Total dose of 500 mg of quercetin | Dietary supplement | Quercetin LipoMicel (500 mg) |
| Quercetin LipoMicel (1000 mg)Quercetin LipoMicel® soft-gels. Total dose of 1000 mg of quercetin | Dietary supplement | Quercetin LipoMicel (1000 mg) |
| Regular/standard Quercetin (500 mg)Total dose of 500 mg of quercetin | Dietary supplement | Regular/standard Quercetin (500 mg) |
Primary outcome
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).
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).
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).
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 37600550Solnier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quercetin LipoMicel (250 mg), Quercetin LipoMicel (500 mg) and Quercetin LipoMicel (1000 mg) in people with Pharmacokinetics, run by Factors Group of Nutritional Companies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.