Safety and Bioavailability of Micellar Green Tea Extract

Isura13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bioavailability and Pharmacokinetics Safety

Interventions

Standard Green TeaDIETARY_SUPPLEMENT

A maximum single dose of 300 mg green tea (hard gel capsules)

Phytosome Green TeaDIETARY_SUPPLEMENT

A maximum single dose of 250 mg green tea (hard gel capsules)

LipoMicel Green TeaDIETARY_SUPPLEMENT

A maximum single dose of 300 mg green tea (soft gel capsules)

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ISURA

Burnaby, British Columbia, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48 hours (post-dose)

Secondary Outcomes

Alanine aminotransferase (ALT)

To evaluate changes in liver function based on ALT.

Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

Aspartate aminotransferase (AST)

To evaluate changes in liver function based on AST.

Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

Total bilirubin (TB)

To evaluate changes in liver function based on total bilirubin.

Data from ClinicalTrials.gov

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