Evaluation of Green Tea for Improving Blood Lipid Profile

NCT06992765 | Active Not Recruiting DMC

• 1 other identifier: lin5611_2
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypercholesterolemia

Keywords

Green tea; Cholesterol; Triglyceride; Blood lipid

Outcome Measures

Primary Outcomes (1)

• Serum total cholesterol

  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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 bottles of light green tea daily containing totally 108 mg of catechin

Dietary Supplement: Placebo

Intervention

EXPERIMENTAL

2 bottles of light green tea daily containing totally 684 mg of catechin

Dietary Supplement: Intervention

Interventions

Intervention DIETARY_SUPPLEMENT

2 bottles of light green tea daily containing totally 684 mg of catechin

Intervention

Placebo DIETARY_SUPPLEMENT

2 bottles of light green tea daily containing totally 108 mg of catechin

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead
• Eagletek Corp.: collaborator

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Methods

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 28, 2025
• Study Start: March 15, 2023
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)