Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea Extracts

Triglycerides High Clinical Trial

Official title:

A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea(Heukcha) Extracts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04850352
• Other study ID #: AP-PV-2018-02
• Status: Completed
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: April 30, 2021

Study information

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

Clinical Trial Summary

This study was conducted to investigate the effects of daily supplementation of Korean Post-Fermented Tea(Heukcha) Extracts on improvement of Blood Triglyceride Level.

Description:

This study was a 8 week, randomized, multicenter, double-blind, placebo-controlled, parallel-design human trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects older than 19 years old

• Who has fasting blood triglyceride levels = 150 mg/dL

• Who voluntarily agreed to participate in the study and signed an informed consent form

Exclusion Criteria:

• Those who are taking functional food designed for dyslipidemia reduction within 4 weeks before study participation

• Those who have been diagnosed and are on medication with dyslipidemia, cardiovascular disease, kidney disease, liver disease or thyroid disease within 4 weeks before study participation

• Fasting plasma glucose >126 mg/dL or treatment with medications including oral hypoglycemic agents or insulin

• Who has used or is expected to inevitably use prohibited concomitant medications during the study

• Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives

• Who has dosed other study medications within 30 days before screening

• Who is determined ineligible for study participation by investigators for any other reasons

Related Conditions & MeSH terms

• Triglycerides High

Intervention

Dietary Supplement:
• Heukcha Extracts
Experimental group: Heukcha Extracts
• Placebo
Placebo group

Locations

Country	Name	City	State
Korea, Republic of	KangBuk Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University	Seoul
Korea, Republic of	St. Vincent's Hospital, College of Medicine, The Catholic University of Korea	Suwon

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 in fasting triglycerides		Baseline, Week 4 and Week 8
Secondary	Change in total cholesterol, LDL-C, HDL-C		Baseline, Week 4 and Week 8
Secondary	Change in BMI (kg/m2)		Baseline, Week 4 and Week 8
Secondary	Change in Waist circumference (cm)		Baseline, Week 4 and Week 8