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RecruitingNCT06592365Updated Sep 19, 2024

Clinical Study to Evaluate the Effects and Safety of Green Tea Extract on Blood Glucose Regulation

An interventional study of GTE and Placebo in Blood Sugar, sponsored by Amorepacific Corporation. Recruiting at 3 sites in Korea, Republic of. Open to participants aged 19 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Amorepacific Corporation · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Registered 2 years after the study started (first participant enrolled Aug 2022, registered Aug 2024).
  • Started Aug 2022; still recruiting 4 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
19 Years to 64 Years
Sex
All
01

Study summary

This study was conducted to investigate the effects of green tea extracts on reducing blood glucose level

Read the detailed description

This study was conducted over 12 weeks with a randomized, double-blind, placebo-controlled, parellel design

02

Conditions studied

  • Blood Sugar
03

In context

Lead sponsor

Amorepacific Corporation is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males and females aged between 19 to 64 years
  • BMI between 18.5 and 29.9kg/m²
  • fasting blood glucose between 100 and 139 mg/dL (Note: if some subjects with blood glucose range of 126 - 139 mg/dL, those who are taking or requre medication must be excluded to meet ethical standards.)
  • subjects who voluntarily decide to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Individuals taking to obesity, dyslipidemia, or uncontrolled hypertension at the screening
  • Individuals diagnosed with diabetes and who have taken medications related to blood glucose
  • Individuals congenital enzyme deficiencies related to sugar metabolism.
  • with hypersensitivity to the test food or ingredients(e.g., green tea, caffeine).
  • Individuals ongoing treatment diseases significantly related glucose metabolism.
  • Individuals with a history of surgery significantly related to glucose metabolism within the last 6 months
  • diagnosed with gastrointestinal diseases, cardiovascular diseases, uncontrolled chronic medical conditions, thyroid disorders, or active malignant tumors requiring medication
  • Individuals with liver function impairment or acute or chronic hepatitis or liver cirrhosis
  • Individuals with renal disorder
  • Individuals with a weight change of 5 kg or more within the last 3 months.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
84 participants (estimated)

Study arms

  • Active comparator
    GTE (Green tea extract)

    three tablets once daily

    Dietary Supplement: GTE

  • Placebo comparator
    Placebo

    three tablets once daily

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementGTE

    oral administration of GTE tablets once daily for 12 weeks

  • Dietary supplementPlacebo

    oral administration of placebo tablets once daily for 12 weeks

06

What researchers measure

Primary outcomes

  1. Change in fasting glucose level

    blood glucose level detection

    Time frame: Baseline, week 12

Secondary outcomes

  1. changes of indicator of lipid metabolism

    Total cholesterol, HDL, LDL, TG

    Time frame: Baseline, week 12

  2. OGTT

    oral glucose tolerance test

    Time frame: Baseline, week 12

  3. blood biomarkers

    insulin etc.

    Time frame: Baseline, week 12

  4. change in waist circumference(cm)

    -waist circumference was measured using WHO guideline

    Time frame: Baseline, week 12

07

Study locations

1 of 3 sites recruiting
  • Kangbuk samsung hospital
    Seoul, Korea, Republic of
    Recruiting
  • Seoul National Universtiy Hospital
    Seoul, Korea, Republic of
    Completed
  • The Catholic University of Korea St. Vincent's Hospital
    Seoul, Korea, Republic of
    Completed
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06592365
Lead sponsor
Amorepacific Corporation
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Aug 8, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Sep 19, 2024

Study contacts

Jonghee Sohn, MS
Contact
sohnjh@amorepacific.com
800-555-5555
HyunJin Nam
Contact
hjnam@amorepacific.com
800-555-5555
Jae-Heon Kang, MD, PhD
principal investigator · Kangbuk Samsung Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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