Safety and Bioavailability of Micellar Green Tea Extract

A Human Clinical Trial on the Pharmacokinetics and Safety of Oral Micellar Green Tea Extract

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.

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