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Evaluation of Green Tea for Improving Blood Lipid Profile

T

Taipei Medical University

Status

Active, not recruiting

Conditions

Hypercholesterolemia

Treatments

Dietary Supplement: Intervention
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06992765
lin5611_2

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

38 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
2 bottles of light green tea daily containing totally 108 mg of catechin
Treatment:
Dietary Supplement: Placebo
Intervention
Experimental group
Description:
2 bottles of light green tea daily containing totally 684 mg of catechin
Treatment:
Dietary Supplement: Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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