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

Not Applicable

Completed

• Conditions: Blood Glucose, High
• Interventions: Dietary Supplement: AP green tea extract

• Registration Number: NCT04850326
• Lead Sponsor: Amorepacific Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-24
• Primary Completion: 2021-01-02
• Study Completion: 2021-02-26
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-20
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AP green tea extract	AP green tea extract	-

Primary Outcome Measures

Name	Time	Method
Change of Insulin level	0 - 300 minute	Change of Insulin level before and after high-carbohydrate/high-fat meal
Change of Triglyceride level	0 - 300 minute	Change of Triglyceride level before and after high-carbohydrate/high-fat meal
Change of Blood glucose level	0 - 300 minute	Change of Blood glucose level before and after high-carbohydrate/high-fat meal

Trial Locations

Locations (1)

KangBuk Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of