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

June 15, 2021 updated by: Amorepacific Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Medical Center
      • Seoul, Korea, Republic of
        • Seoul National University
      • Suwon, Korea, Republic of
        • St. Vincent's Hospital, College of Medicine, The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heukcha Extracts
Take Heukcha Extracts capsule once daily for 8 weeks.
Dietary supplement: Heukcha Extracts
Experimental group: Heukcha Extracts
Placebo Comparator: Placebo
Take placebo capsule once daily for 8 weeks.
Dietary supplement: Placebo
Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in fasting triglycerides
Time Frame: Baseline, Week 4 and Week 8
Baseline, Week 4 and Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amorepacific Corporation

Investigators

  • Principal Investigator: Belong Cho, MD, PhD, Seoul National University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2019

Primary Completion (Actual)

March 3, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 18, 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-PV-2018-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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