Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea Extracts
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
1 other identifier
interventional
100
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2021
CompletedFirst Submitted
Initial submission to the registry
April 14, 2021
CompletedFirst Posted
Study publicly available on registry
April 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedJune 16, 2021
June 1, 2021
1.9 years
April 14, 2021
June 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in fasting triglycerides
Baseline, Week 4 and Week 8
Secondary Outcomes (3)
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
Study Arms (2)
Heukcha Extracts
EXPERIMENTALTake Heukcha Extracts capsule once daily for 8 weeks.
Placebo
PLACEBO COMPARATORTake placebo capsule once daily for 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
KangBuk Samsung Medical Center
Seoul, 03181, South Korea
Seoul National University
Seoul, South Korea
St. Vincent's Hospital, College of Medicine, The Catholic University of Korea
Suwon, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Belong Cho, MD, PhD
Seoul National University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2021
First Posted
April 20, 2021
Study Start
April 3, 2019
Primary Completion
March 3, 2021
Study Completion
April 30, 2021
Last Updated
June 16, 2021
Record last verified: 2021-06