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Safety and Bioavailability of Micellar Green Tea Extract

NCT06971536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-05-14

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Isura

    lead OTHER

Principal Investigators

  • Julia Solnier · Isura

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-10
Primary Completion
2024-09-13
Completion
2025-03-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06971536 on ClinicalTrials.gov