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

Amorepacific

Status

Completed

Conditions

Triglycerides High

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Heukcha Extracts

Study type

Interventional

Funder types

Industry

Identifiers

NCT04850352

AP-PV-2018-02

Details and patient eligibility

About

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

Full description

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

Enrollment

100 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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