Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea Extracts

Study Overview
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Brief Summary
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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
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This study was a 8 week, randomized, multicenter, double-blind, placebo-controlled, parallel-design human trial.

Official Title
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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

Conditions
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Triglycerides High

Intervention / Treatment
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* Dietary Supplement: Heukcha Extracts
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heukcha Extracts<br>Take Heukcha Extracts capsule once daily for 8 weeks. | Dietary Supplement: Heukcha Extracts<br>* Experimental group: Heukcha Extracts<br>|
| Placebo Comparator: Placebo<br>Take placebo capsule once daily for 8 weeks. | Dietary Supplement: Placebo<br>* Placebo group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting triglycerides |  | Baseline, Week 4 and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |