Status:
COMPLETED
Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea Extracts
Lead Sponsor:
Amorepacific Corporation
Conditions:
Triglycerides High
Eligibility:
All Genders
19+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04850352
Start Date
April 3 2019
End Date
April 30 2021
Last Update
June 16 2021
Active Locations (3)
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1
KangBuk Samsung Medical Center
Seoul, South Korea, 03181
2
Seoul National University
Seoul, South Korea
3
St. Vincent's Hospital, College of Medicine, The Catholic University of Korea
Suwon, South Korea