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

NCT ID: NCT04850352

Last Updated: 2021-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2021-04-30

Brief Summary

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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

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

Conditions

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Triglycerides High

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Heukcha Extracts

Take Heukcha Extracts capsule once daily for 8 weeks.

Group Type EXPERIMENTAL

Heukcha Extracts

Intervention Type DIETARY_SUPPLEMENT

Experimental group: Heukcha Extracts

Placebo

Take placebo capsule once daily for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo group

Interventions

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Heukcha Extracts

Experimental group: Heukcha Extracts

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo group

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amorepacific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Belong Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

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KangBuk Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul National University

Seoul, , South Korea

Site Status

St. Vincent's Hospital, College of Medicine, The Catholic University of Korea

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AP-PV-2018-02

Identifier Type: -

Identifier Source: org_study_id

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