Evaluation of Green Tea for Improving Blood Lipid Profile

May 19, 2025 updated by: Taipei Medical University

Evaluation of Heysong Japanese Green Tea for Improving Blood Lipid Function

The objects of this study are to evaluate the effects of the "Heysong japanese green tea" on the human subjects who are dyslipidemia. In this trial, 40 healthy subjects whose ages are 18~65 years old (20 for placebo and 20 for experimental) will be included. The total experiment will be 16 weeks and the intervention period will be 12 weeks, within which, at wk 0, 2, 8, 14 and 16, serum triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) values would be measured. Urine/feces samples and anthropometric data will also be acquired. The results will be analyzed according to the methods published by the Ministry of Health and Welfare of Taiwan Food and Drug Administration.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female. Age between 18-65 years old.

  • Those who have been assessed as dyslipidemia by a family physician but have not yet required medication. The following measurement values were used as evaluation criteria:

    1. Hypercholesterolemia: plasma total cholesterol (TC) >200 mg/dL;
    2. Mixed hyperlipidemia: plasma total cholesterol (TC) >200 mg/dL , triglyceride (TG) >200 mg/dL;
    3. Hypertriglyceridemia: plasma triglyceride (TG) >200 mg/dL, and high-density lipoprotein cholesterol (HDL-C) < 35 mg/dL or TC/HDL-C >5.

Exclusion Criteria:

  • Pregnant, breastfeeding, menopausal women.
  • Take any drugs or supplements that can affect blood lipid levels 2 weeks before or during the experiment.
  • People with intolerance to caffeine or green tea.
  • People who take drugs for chronic diseases.
  • People who smoke or drink alcohol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
2 bottles of light green tea daily containing totally 108 mg of catechin
Dietary supplement: Placebo
2 bottles of light green tea daily containing totally 108 mg of catechin
Experimental: Intervention
2 bottles of light green tea daily containing totally 684 mg of catechin
Dietary supplement: Intervention
2 bottles of light green tea daily containing totally 684 mg of catechin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum total cholesterol
Time Frame: Wk(-2), Week(0) (Baseline), Wk(6), Wk(12) and Wk(14)
Total cholesterol is measured by the Department of Laboratory Medicine of Taipei Medical University Hospital (TMUH)
Wk(-2), Week(0) (Baseline), Wk(6), Wk(12) and Wk(14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Collaborators

Eagletek Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

May 9, 2025

First Submitted That Met QC Criteria

May 19, 2025

First Posted (Actual)

May 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lin5611_2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Total cholesterol in serum

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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