Clinical Study to Evaluate the Short Time Efficacy of AP Green Tea Extract Affer High Fat, High Carbohydrate Diet

A Randomized, Cross-Over Clinical Study to Evaluate the Acute Efficacy of AP Green Tea Extract After a Meal Composed of High-Fat/High-Carbohydrate

The objective of this clinical trial is to evaluate the short term effects of single dose AP green tea extracts in subjects with BMI (< 30 kg/m2) and fasting glucose level of > 100 mg/dL after high-fat/high-carbohydrate meal.

Study Overview

• Status: Completed
• Conditions: Blood Glucose, High
• Intervention / Treatment: Dietary supplement: AP green tea extract

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects aged 19 years or over
• BMI < 30 kg/m2
• Fasting glucose level > 100 mg/dL (who is not under medication)
• Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives

Exclusion Criteria:

• At the screening visit, subjects who were diagnosed with obesity, diabetes, dyslipidemia and undergoing medication
• Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, hyper/hypothyroidism, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product
• Subjects who have renal failure, acute or chronic hepatitis or known liver cirrhosis
• In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AP green tea extract	Dietary supplement: AP green tea extract; single intake of AP green tea extract
No Intervention: No intervention control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Blood glucose level	Change of Blood glucose level before and after high-carbohydrate/high-fat meal	0 - 300 minute
Change of Insulin level	Change of Insulin level before and after high-carbohydrate/high-fat meal	0 - 300 minute
Change of Triglyceride level	Change of Triglyceride level before and after high-carbohydrate/high-fat meal	0 - 300 minute

Collaborators and Investigators

• Sponsor: Amorepacific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Actual): January 2, 2021
• Study Completion (Actual): February 26, 2021

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AP-R-2019-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No