The Effect of Extract of Green Tea on Obese Women and Obese Related Hormone Peptides

May 21, 2014 updated by: Chung-Hua Hsu, Taipei City Hospital

The Effect of Extract of Green Tea on Obese Women Obese Related Hormone Peptides

The aim of this study is to examine the therapeutic effect of green tea extract on obese women and the correlation analysis between traditional Chinese medicine syndrome and obese related hormone peptides.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Obesity has become a noticeable and worldwide public health problem recently. According to the WHO survey in 2005, 1.6 billion and 400 million adults were found overweight and obese, respectively. In Taiwan, there are more than 30% found overweight in the national survey in 2009. Compare with the ones done in 1999 and 2005, a rising trend of the prevalence of obesity is found. Furthermore, the incidence and prevalence of obesity are also increasing worldwide, especially in the developing and newly industrialized nations. In addition, obesity is related to some chronic diseases, like diabetes mellitus, hyperlipidemia and cardiovascular diseases, which are major lethal health concerns in Taiwan and many developing countries. Taken together, obesity emerges as an important issue lately. The aim of the study is to evaluate the therapeutic effect and safety of green tea extract on demographic characteristics and obesity-related hormone peptide of obese women and to establish an obesity Traditional Chinese Medicine (TCM) syndromes questionnaire, which will undergo well assessing of reliability and validity. Second, we intent to utilize the TCM syndromes and Quality of Life (SF-12, WHO) questionnaire to 200 obesity women for the correlation analysis of TCM syndromes, obesity related hormone peptides and quality of life. The results of this study are expected to assess the effect and safety of green tea extract on obese women and improve the scientific diagnosis of TCM with a quantitative measurement by this questionnaire.

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Phase 2
  • Phase 3

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 City Hospital

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • aged between 20 and 60 years old women
  • Chinese
  • body mass index (BMI) > 27 kg/m2
  • waist circumference (WC) > 80 cm
  • willing to participate in and fill out the questionnaires for this trial.

Exclusion Criteria:

  • GPT > 80 U/L, serum creatinine > 2.0 mg/dl
  • breast feeding or pregnancy
  • heart failure
  • acute myocardial infarction
  • Stroke
  • any other conditions not suitable for trial as evaluated by the physician

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGCG(Epigallocatechin Gallate)
EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks)
Drug: EGCG(Epigallocatechin Gallate)
500mg, three times a day, duration:12 weeks
Other Names:
  • EGCG-Epigallocatechin Gallate, green tea extract
  • cellulose-cellulose
Placebo Comparator: placebo
cellulose (500mg, three times a day, 12 weeks)
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite of anthropometric measures
Time Frame: compare between the beginning of the study and after 12 weeks of treatment.
composite include body weight, waist circumference, hip circumference
compare between the beginning of the study and after 12 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hormone peptide change
Time Frame: compared between the beginning of the study and after 12 weeks of treatment
hormone peptides such as leptin、adiponectin、ghrelin、fasting insulin resistance、APOB、APOA1
compared between the beginning of the study and after 12 weeks of treatment
biochemical characteristic change
Time Frame: compare between the beginning of the study and after 12 weeks of treatment.
blood sugar, creatinine, aminotransferases aspartate, aminotransferases alanine, uric acid and
compare between the beginning of the study and after 12 weeks of treatment.
traditional chinese medicine syndrome classification
Time Frame: compare between the beginning of the study and after 12 weeks of treatment.
Use questionaire to classify traditional chinese medicine syndrome in obese women
compare between the beginning of the study and after 12 weeks of treatment.
Quality of life evaluation
Time Frame: compare between the beginning of the study and after 12 weeks of treatment.
(1)12-item Short-Form Health Survey (2)WHOQoL-BREF
compare between the beginning of the study and after 12 weeks of treatment.

Collaborators and Investigators

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

Sponsor

Taipei City Hospital

Collaborators

National Yang Ming University

Investigators

  • Study Chair: Chung-Hua Hsu, PHD, Taipei medical hospital, Linsen Chinese Medicine branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2012

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

May 26, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100XDAA00110 (Other Grant/Funding Number: 100XDAA00110)

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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