Safety and Bioavailability of Micellar Green Tea Extract (GT Safety & BA)

Isura

Status: Completed

Conditions: Safety; Bioavailability and Pharmacokinetics

Treatments: Dietary Supplement: LipoMicel Green Tea; Dietary Supplement: Standard Green Tea; Dietary Supplement: Phytosome Green Tea

Study type: Interventional

Funder types: Other

Identifiers

NCT06971536

2022-11-002GT

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 3 patient groups

Standard Green Tea

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Standard Green Tea

Phytosome Green Tea

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Phytosome Green Tea

LipoMicel Green Tea

Experimental group

Description:

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.

Treatment:

Dietary Supplement: LipoMicel Green Tea