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Completed

NCT Number: NCT04850352

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

This study was conducted to investigate the effects of daily supplementation of Korean Post-Fermented Tea(Heukcha) Extracts on improvement of Blood Triglyceride Level.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KangBuk Samsung Medical Center, Seoul, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heukcha Extracts

Dietary Supplement

Experimental group: Heukcha Extracts

Placebo

Dietary Supplement

Placebo group

Primary outcomes

  1. Change in fasting triglycerides

    Time frame: Baseline, Week 4 and Week 8

Secondary outcomes

  1. Change in total cholesterol, LDL-C, HDL-C

    Time frame: Baseline, Week 4 and Week 8

  2. Change in BMI (kg/m2)

    Time frame: Baseline, Week 4 and Week 8

  3. Change in Waist circumference (cm)

    Time frame: Baseline, Week 4 and Week 8

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2021
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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