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This study seeks to determine the short-term effects of daily oral supplementation of LipoMicel Green Tea on oral absorption and safety of green tea in healthy volunteers.
The primary objective is to evaluate and compare the pharmacokinetics of LipoMicel Green Tea (LGT) with that of a standard green tea extract formulation as well as a phytosomal green tea formulation. The secondary objective is to evaluate the safety of LGT in healthy human participants over a 30-day study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Green Tea | Experimental | Each participant receives their treatment i.e., Standard Green Tea hard gel capsules at a total dose of 300 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used. |
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| Phytosome Green Tea | Experimental | Each participant receives their treatment i.e., Phytosome green tea hard gel capsules at a total dose of 250 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 hours post-dose. A washout period of at least 7 days between each treatment is used. |
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| LipoMicel Green Tea | Experimental | Each participant receives their treatment i.e., LipoMicel green tea soft gel capsules at a total dose of 300 mg green tea extract. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 48 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 |
|---|---|---|---|---|
| Standard Green Tea | Dietary Supplement | A maximum single dose of 300 mg green tea (hard gel capsules) |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC: the area under the concentration-time curve | To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing green tea extract. | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose) |
| Cmax: maximum plasma concentration | To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing green tea extract. | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose) |
| Tmax: the time point of maximum plasma concentration | To determine the gastrointestinal absorption of orally ingested green tea extract in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing green tea extract. | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Alanine aminotransferase (ALT) | To evaluate changes in liver function based on ALT. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Aspartate aminotransferase (AST) | To evaluate changes in liver function based on AST. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Solnier | 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 48 hours; subsequently, the safety of LipoMicel Green tea intervention with the higher bioavailability is evaluated in a subsequent single-arm, 30-day trial.
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| Phytosome Green Tea | Dietary Supplement | A maximum single dose of 250 mg green tea (hard gel capsules) |
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| LipoMicel Green Tea | Dietary Supplement | A maximum single dose of 300 mg green tea (soft gel capsules) |
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| 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Total bilirubin (TB) | To evaluate changes in liver function based on total bilirubin. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Serum creatinine | To evaluate changes in kidney function based on serum creatinine. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Glomerular filtration rate (GFR) | To evaluate changes in kidney function based on GFR. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Fasting blood glucose | To evaluate changes in blood glucose levels based on fasting blood glucose. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Total cholesterol | To evaluate changes in lipid profile based on total cholesterol. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Triglycerides | To evaluate changes in lipid profile based on triglycerides. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Low-density lipoprotein (LDL) cholesterol | To evaluate changes in lipid profile based on LDL. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| High-density lipoprotein (HDL) cholesterol | To evaluate changes in lipid profile based on HDL. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |