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NCT Number: NCT06592365

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

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

Recruiting

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Key information

Conditions

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk samsung hospital, Seoul, South Korea

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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.

Treatment and study plan

GTE

Dietary Supplement

oral administration of GTE tablets once daily for 12 weeks

Placebo

Dietary Supplement

oral administration of placebo tablets once daily for 12 weeks

Primary outcomes

  1. Change in fasting glucose level

    Time frame: Baseline, week 12

    blood glucose level detection

Secondary outcomes

  1. changes of indicator of lipid metabolism

    Time frame: Baseline, week 12

    Total cholesterol, HDL, LDL, TG

  2. OGTT

    Time frame: Baseline, week 12

    oral glucose tolerance test

  3. blood biomarkers

    Time frame: Baseline, week 12

    insulin etc.

  4. change in waist circumference(cm)

    Time frame: Baseline, week 12

    -waist circumference was measured using WHO guideline

Study contacts

Contact information is provided by the study sponsor or research team.

HyunJin Nam

CONTACT

[email protected]

800-555-5555

Jonghee Sohn, MS

CONTACT

[email protected]

800-555-5555

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effects and Safety of Green Tea Extract(GTE) Consumption on Blood Glucose Regulation

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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