Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea Extracts
Not Applicable
Completed
- Conditions
- Triglycerides High
- 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.
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
- 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)
KangBuk Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University
🇰🇷Seoul, Korea, Republic of
St. Vincent's Hospital, College of Medicine, The Catholic University of Korea
🇰🇷Suwon, Korea, Republic of
KangBuk Samsung Medical Center🇰🇷Seoul, Korea, Republic of