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

Blood Glucose, High Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04850326
• Other study ID #: AP-R-2019-02
• Status: Completed
• Phase: N/A
• Start date: July 24, 2020
• Est. completion date: February 26, 2021

Study information

• Verified date: June 2021
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 26, 2021
• Est. primary completion date: January 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Glucose, High
• Hyperglycemia

Intervention

Dietary Supplement:
• AP green tea extract
single intake of AP green tea extract

Locations

Country	Name	City	State
Korea, Republic of	KangBuk Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Blood glucose level	Change of Blood glucose level before and after high-carbohydrate/high-fat meal	0 - 300 minute
Primary	Change of Insulin level	Change of Insulin level before and after high-carbohydrate/high-fat meal	0 - 300 minute
Primary	Change of Triglyceride level	Change of Triglyceride level before and after high-carbohydrate/high-fat meal	0 - 300 minute