Triglycerides High Clinical Trial
Official title:
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
Verified date | June 2021 |
Source | Amorepacific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was conducted to investigate the effects of daily supplementation of Korean Post-Fermented Tea(Heukcha) Extracts on improvement of Blood Triglyceride Level.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 30, 2021 |
Est. primary completion date | March 3, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | 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 |
Lead Sponsor | Collaborator |
---|---|
Amorepacific Corporation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in fasting triglycerides | Baseline, Week 4 and Week 8 | ||
Secondary | Change in total cholesterol, LDL-C, HDL-C | Baseline, Week 4 and Week 8 | ||
Secondary | Change in BMI (kg/m2) | Baseline, Week 4 and Week 8 | ||
Secondary | Change in Waist circumference (cm) | Baseline, Week 4 and Week 8 |
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