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

Not Applicable

Completed

• Conditions: Triglycerides High
• Interventions: Dietary Supplement: Heukcha Extracts; Dietary Supplement: Placebo

• Registration Number: NCT04850352
• Lead Sponsor: Amorepacific Corporation

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2019-04-03
• Primary Completion: 2021-03-03
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-18
• Study First Posted: 2021-04-20
• Study Completion: 2021-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heukcha Extracts	Heukcha Extracts	Take Heukcha Extracts capsule once daily for 8 weeks.
Placebo	Placebo	Take placebo capsule once daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in fasting triglycerides	Baseline, Week 4 and Week 8

Secondary Outcome Measures

Name	Time	Method
Change in total cholesterol, LDL-C, HDL-C	Baseline, Week 4 and Week 8
Change in BMI (kg/m2)	Baseline, Week 4 and Week 8
Change in Waist circumference (cm)	Baseline, Week 4 and Week 8

Trial Locations

Locations (3)

St. Vincent's Hospital, College of Medicine, The Catholic University of Korea; 🇰🇷 Suwon, Korea, Republic of

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

Seoul National University; 🇰🇷 Seoul, Korea, Republic of