Bioavailability and PharmacokineticsNCT07066839
Chrysin Bioavailability and Safety
A study testing LipoMicel Chrysin, Non-Micellar Chrysin and Standard/Unformulated Chrysin in people with Bioavailability and Pharmacokinetics and Safety After Oral Intake, run by Isura at 1 site in Canada.
Trial summary
This study seeks to evaluate and compare the pharmacokinetics of a micellar chrysin formulation (LipoMicel Chrysin) with that of a non-micellar chrysin formulation as well as a standard/unformulated chrysin supplement. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability and Pharmacokinetics, Safety After Oral Intake
- What is being tested?
- LipoMicel Chrysin, Non-Micellar Chrysin and Standard/Unformulated Chrysin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2024to 2 Apr 2025
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female aged 21-65 years
- healthy, good physical condition
- voluntary, written, informed consent to participate in the study.
Who cannot join
- use of anti-inflammatory or non-steroidal anti-inflammatory drugs
- previous history of cardiovascular disease or acute or chronic inflammatory disease
- use of antioxidant or polyphenol supplements or cholesterol-lowering agents
- change of diet habits or lifestyle (diet, physical activity, etc.)
- alcohol or substance abuse history
- use of nicotine or tobacco
- participation in another investigational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Bioavailability of Three Chrysin Formulations in Healthy Adults
This study seeks to evaluate and compare the pharmacokinetics of a micellar chrysin formulation (LipoMicel Chrysin) with that of a non-micellar chrysin formulation as well as a standard/unformulated chrysin supplement. The study also seeks to determine the short-term effects and safety of daily oral supplementation of LipoMicel Chrysin in healthy adult volunteers over a 30-day study period.
- Being tested
- LipoMicel Chrysin, Non-Micellar Chrysin, Standard/Unformulated Chrysin
- Keywords
- chrysin, pharmacokinetics, bioavailability, micellar delivery, natural health products, caco-2 permeability, safety, dietary supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoMicel ChrysinDietary supplement
A maximum single oral dose of 1000 mg chrysin
Non-Micellar ChrysinDietary supplement
A maximum single oral dose of 1000 mg chrysin
Standard/Unformulated ChrysinDietary supplement
A maximum single oral dose of 1000 mg chrysin
| Study group | Role | What they receive |
|---|---|---|
| LipoMicel Chrysin | Experimental | Each participant receives their treatment i.e., LipoMicel Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used. Receives: Dietary Supplement: LipoMicel Chrysin |
| Non-micellar Chrysin | Experimental | Each participant receives their treatment i.e., Non-Micellar Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used. Receives: Dietary Supplement: Non-Micellar Chrysin |
| Standard Unformulated Chrysin | Experimental | Each participant receives their treatment i.e., Standard Unformulated Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used. Receives: Dietary Supplement: Standard/Unformulated Chrysin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: maximum plasma concentration
To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing chrysin.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]
AUC: the area under the concentration-time curve
To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing chrysin.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]
Tmax: the time point of maximum plasma concentration
To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax)
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]
Secondary outcomes (11)
Alanine aminotransferase (ALT)
To evaluate changes in liver function based on ALT.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Aspartate aminotransferase (AST)
To evaluate changes in liver function based on AST.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Total bilirubin (TB)
To evaluate changes in liver function based on total bilirubin.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Serum creatinine
To evaluate changes in kidney function based on serum creatinine.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Glomerular filtration rate (GFR)
To evaluate changes in kidney function based on GFR.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Fasting blood glucose
To evaluate changes in blood glucose levels based on fasting blood glucose.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
HbA1c
To evaluate changes in blood glucose levels based on HbA1c.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Total cholesterol
To evaluate changes in lipid profile based on total cholesterol.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)]
Triglycerides
To evaluate changes in lipid profile based on triglycerides.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)]
Low-density lipoprotein (LDL) cholesterol
To evaluate changes in lipid profile based on LDL.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)]
High-density lipoprotein (HDL) cholesterol
To evaluate changes in lipid profile based on HDL.
Measured: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start5 Dec 2024
- Primary completion21 Feb 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability and 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
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of LipoMicel Chrysin intervention with the higher bioavailability is evaluated in a subsequent single-arm, 30-day trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Solnier, PhD, Principal investigator, Isura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066839
- Sponsor's protocol ID
- 2022-11-002CR
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Bioavailability of Three Chrysin Formulations in Healthy Adults
- ClinicalTrials.gov ID
- NCT07066839
- Acronym / sponsor ID
- 2022-11-002CR
- Keywords
- chrysin, pharmacokinetics, bioavailability, micellar delivery, natural health products, caco-2 permeability, safety, dietary supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- IsuraUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 15 Jul 2025 (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 seeks to evaluate and compare the pharmacokinetics of a micellar chrysin formulation (LipoMicel Chrysin) with that of a non-micellar chrysin formulation as well as a standard/unformulated chrysin supplement. The study also seeks to determine the short-term effects and safety of daily oral supplementation of LipoMicel Chrysin in healthy adult volunteers over a 30-day study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of LipoMicel Chrysin intervention with the higher bioavailability is evaluated in a subsequent single-arm, 30-day trial.
| Arm | Type | Receives |
|---|---|---|
| LipoMicel Chrysin | Experimental | Dietary Supplement: LipoMicel ChrysinEach participant receives their treatment i.e., LipoMicel Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used. |
| Non-micellar Chrysin | Experimental | Dietary Supplement: Non-Micellar ChrysinEach participant receives their treatment i.e., Non-Micellar Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used. |
| Standard Unformulated Chrysin | Experimental | Dietary Supplement: Standard/Unformulated ChrysinEach participant receives their treatment i.e., Standard Unformulated Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female aged 21-65 years
- healthy, good physical condition
- voluntary, written, informed consent to participate in the study.
Key exclusion criteria (7 listed)
- use of anti-inflammatory or non-steroidal anti-inflammatory drugs
- previous history of cardiovascular disease or acute or chronic inflammatory disease
- use of antioxidant or polyphenol supplements or cholesterol-lowering agents
- change of diet habits or lifestyle (diet, physical activity, etc.)
- alcohol or substance abuse history
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 |
|---|---|---|
| LipoMicel ChrysinA maximum single oral dose of 1000 mg chrysin | Dietary supplement | LipoMicel Chrysin |
| Non-Micellar ChrysinA maximum single oral dose of 1000 mg chrysin | Dietary supplement | Non-micellar Chrysin |
| Standard/Unformulated ChrysinA maximum single oral dose of 1000 mg chrysin | Dietary supplement | Standard Unformulated Chrysin |
Primary outcome
Cmax: maximum plasma concentration
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]
To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing chrysin.
AUC: the area under the concentration-time curve
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]
To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing chrysin.
Tmax: the time point of maximum plasma concentration
Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]
To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax)
11 secondary outcomes
Alanine aminotransferase (ALT)
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Aspartate aminotransferase (AST)
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Total bilirubin (TB)
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Serum creatinine
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Glomerular filtration rate (GFR)
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Fasting blood glucose
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
HbA1c
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]
Total cholesterol
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)]
Triglycerides
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)]
Low-density lipoprotein (LDL) cholesterol
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)]
High-density lipoprotein (HDL) cholesterol
Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)]
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 15 Jul 2025.
- 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.
Julia Solnier, PhD principal investigator
Isura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LipoMicel Chrysin, Non-Micellar Chrysin and Standard/Unformulated Chrysin in people with Bioavailability and Pharmacokinetics and Safety After Oral Intake, run by Isura 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 3 inclusion and 7 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 15 Jul 2025. 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?
Cmax: maximum plasma concentration (time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]). 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?
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 15 Jul 2025.