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Completed

NCT Number: NCT06971536

Safety and Bioavailability of 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.

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Key information

Conditions

Bioavailability and Pharmacokinetics Safety

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ISURA

Burnaby, British Columbia, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Green Tea

Dietary Supplement

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

Phytosome Green Tea

Dietary Supplement

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

LipoMicel Green Tea

Dietary Supplement

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

Primary outcomes

  1. AUC: the area under the concentration-time curve

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

    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.

  2. Cmax: maximum plasma concentration

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

    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.

  3. Tmax: the time point of maximum plasma concentration

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

    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.

Secondary outcomes

  1. Alanine aminotransferase (ALT)

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

    To evaluate changes in liver function based on ALT.

  2. Aspartate aminotransferase (AST)

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

    To evaluate changes in liver function based on AST.

  3. Total bilirubin (TB)

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

    To evaluate changes in liver function based on total bilirubin.

  4. Serum creatinine

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

    To evaluate changes in kidney function based on serum creatinine.

  5. Glomerular filtration rate (GFR)

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

    To evaluate changes in kidney function based on GFR.

  6. Fasting blood glucose

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

    To evaluate changes in blood glucose levels based on fasting blood glucose.

  7. Total cholesterol

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

    To evaluate changes in lipid profile based on total cholesterol.

  8. Triglycerides

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

    To evaluate changes in lipid profile based on triglycerides.

  9. Low-density lipoprotein (LDL) cholesterol

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

    To evaluate changes in lipid profile based on LDL.

  10. High-density lipoprotein (HDL) cholesterol

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

    To evaluate changes in lipid profile based on HDL.

Sponsors and collaborators

Lead sponsor

Isura

Other

Registry information

Official study title

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

Acronym: GT Safety & BA

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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