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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LipoMicel Chrysin | Dietary Supplement | A maximum single oral dose of 1000 mg chrysin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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) | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)] |
| Measure | Description | Time Frame |
|---|---|---|
| Alanine aminotransferase (ALT) | To evaluate changes in liver function based on ALT. | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)] |
| Aspartate aminotransferase (AST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Solnier, PhD | Isura | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISURA | Burnaby | British Columbia | Canada |
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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.
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| Non-Micellar Chrysin |
| Dietary Supplement |
A maximum single oral dose of 1000 mg chrysin |
|
| Standard/Unformulated Chrysin | Dietary Supplement | A maximum single oral dose of 1000 mg chrysin |
|
To evaluate changes in liver function based on AST.
| [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. | [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. | [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. | [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. | [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. | [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. | [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. | [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. | [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. | [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3, and week 4 (post-dose)] |