Bioavailability and Pharmacokinetics, Safety
Conditions
Keywords
pharmacokinetics, green tea extract, bioavailability, safety, micellar delivery system
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTStandard Green Tea
A maximum single dose of 300 mg green tea (hard gel capsules)
DIETARY_SUPPLEMENTPhytosome Green Tea
A maximum single dose of 250 mg green tea (hard gel capsules)
DIETARY_SUPPLEMENTLipoMicel Green Tea
A maximum single dose of 300 mg green tea (soft gel capsules)
Sponsors
Isura
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* male or female aged 21-65 years * healthy, good physical condition * voluntary, written, informed consent to participate in the study.
Exclusion criteria
* use of anti-inflammatory or non-steroidal anti-inflammatory drugs * previous history of cardiovascular disease or acute or chronic inflammatory disease * use of antioxidant 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC: the area under the concentration-time curve | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose) | 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. |
| Cmax: maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose) | 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. |
| Tmax: the time point of maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in kidney function based on serum creatinine. |
| Glomerular filtration rate (GFR) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in kidney function based on GFR. |
| Fasting blood glucose | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in blood glucose levels based on fasting blood glucose. |
| Alanine aminotransferase (ALT) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in liver function based on ALT. |
| Triglycerides | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in lipid profile based on triglycerides. |
| Low-density lipoprotein (LDL) cholesterol | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in lipid profile based on LDL. |
| High-density lipoprotein (HDL) cholesterol | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in lipid profile based on HDL. |
| Total cholesterol | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in lipid profile based on total cholesterol. |
| Aspartate aminotransferase (AST) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in liver function based on AST. |
| Total bilirubin (TB) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in liver function based on total bilirubin. |
Countries
Canada
Outcome results
None listed