Clinical trial NCT06971536: Safety and Bioavailability of Micellar Green Tea Extract
Official title: A Human Clinical Trial on the Pharmacokinetics and Safety of Oral Micellar Green Tea Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability and Pharmacokinetics
Safety
Keywords: pharmacokinetics
green tea extract
bioavailability
safety
micellar delivery system
Lead sponsor: Isura
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC: the area under the concentration-time curve
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)
measure: Cmax: maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)
measure: Tmax: the time point of maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)
Secondary outcomes:
measure: Alanine aminotransferase (ALT)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Aspartate aminotransferase (AST)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Total bilirubin (TB)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Serum creatinine
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Glomerular filtration rate (GFR)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Fasting blood glucose
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Total cholesterol
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Triglycerides
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: High-density lipoprotein (HDL) cholesterol
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: ISURA
state: British Columbia
Study officials:
affiliation: Isura
name: Julia Solnier
role: PRINCIPAL_INVESTIGATOR
References: