Safety and Bioavailability of Micellar Green Tea Extract

NCT06971536 | Completed

• 1 other identifier: 2022-11-002GT
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pharmacokinetics; green tea extract; bioavailability; safety; micellar delivery system

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (10)

• Alanine aminotransferase (ALT)

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

• Aspartate aminotransferase (AST)

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

• Total bilirubin (TB)

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

• Serum creatinine

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

• Glomerular filtration rate (GFR)

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

Study Arms (3)

Standard Green Tea

EXPERIMENTAL

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.

Dietary Supplement: Standard Green Tea

Phytosome Green Tea

EXPERIMENTAL

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.

Dietary Supplement: Phytosome Green Tea

LipoMicel Green Tea

EXPERIMENTAL

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.

Dietary Supplement: LipoMicel Green Tea

Interventions

Standard Green Tea DIETARY_SUPPLEMENT

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

Standard Green Tea

Phytosome Green Tea DIETARY_SUPPLEMENT

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

Phytosome Green Tea

LipoMicel Green Tea DIETARY_SUPPLEMENT

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

LipoMicel Green Tea

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female aged 21-65 years
• healthy, good physical condition
• voluntary, written, informed consent to participate in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Isura: lead

Study Sites (1)

ISURA

Burnaby, British Columbia, Canada

Location

Study Officials

• Julia Solnier

  Isura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 48 hours; subsequently, the safety of LipoMicel Green tea intervention with the higher bioavailability is evaluated in a subsequent single-arm, 30-day trial.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: December 10, 2023
• Primary Completion: September 13, 2024
• Study Completion: March 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)