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

NCT06592365 | Recruiting

• 1 other identifier: AP-R-2019-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Blood Sugar

Outcome Measures

Primary Outcomes (1)

• Change in fasting glucose level

  blood glucose level detection

  Baseline, week 12

Secondary Outcomes (4)

• changes of indicator of lipid metabolism

  Baseline, week 12

• OGTT

  Baseline, week 12

• blood biomarkers

  Baseline, week 12

• change in waist circumference(cm)

  Baseline, week 12

Study Arms (2)

GTE (Green tea extract)

ACTIVE COMPARATOR

three tablets once daily

Dietary Supplement: GTE

Placebo

PLACEBO COMPARATOR

three tablets once daily

Dietary Supplement: Placebo

Interventions

GTE DIETARY_SUPPLEMENT

oral administration of GTE tablets once daily for 12 weeks

GTE (Green tea extract)

Placebo DIETARY_SUPPLEMENT

oral administration of placebo tablets once daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amorepacific Corporation: lead

Study Sites (3)

Kangbuk samsung hospital

Seoul, South Korea

RECRUITING

Seoul National Universtiy Hospital

Seoul, South Korea

COMPLETED

The Catholic University of Korea St. Vincent's Hospital

Seoul, South Korea

COMPLETED

Study Officials

• Jae-Heon Kang, MD, PhD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonghee Sohn, MS

CONTACT

800-555-5555; sohnjh@amorepacific.com

HyunJin Nam

CONTACT

800-555-5555; hjnam@amorepacific.com

Study Design

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

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: September 19, 2024
• Study Start: August 8, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

KR (3)