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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04850352

Enrollment

100

Registered

2021-04-20

Start date

2019-04-03

Completion date

2021-04-30

Last updated

2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triglycerides High

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.

Interventions

DIETARY_SUPPLEMENTHeukcha Extracts

Experimental group: Heukcha Extracts

DIETARY_SUPPLEMENTPlacebo

Placebo group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in fasting triglycerides	Baseline, Week 4 and Week 8

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026