NCT06971536

Safety and Bioavailability of Micellar Green Tea Extract

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Isura · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioavailability and Pharmacokinetics
• Safety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Standard Green Tea	A maximum single dose of 300 mg green tea (hard gel capsules)
DIETARY_SUPPLEMENT	Phytosome Green Tea	A maximum single dose of 250 mg green tea (hard gel capsules)
DIETARY_SUPPLEMENT	LipoMicel Green Tea	A maximum single dose of 300 mg green tea (soft gel capsules)

Timeline

• Start date: 2023-12-10
• Primary completion: 2024-09-13
• Completion: 2025-03-30
• First posted: 2025-05-14
• Last updated: 2025-05-14

Locations

1 site across 1 country: Canada