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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Hyperlipidemia

Intervention / Treatment
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* Drug: EGCG(Epigallocatechin Gallate)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGCG(Epigallocatechin Gallate)<br>EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks) | Drug: EGCG(Epigallocatechin Gallate)<br>* 500mg, three times a day, duration:12 weeks<br>* Other names: cellulose-cellulose;|
| Placebo Comparator: placebo<br>cellulose (500mg, three times a day, 12 weeks) | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of anthropometric measures | 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 | 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 | 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 | 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 | (1)12-item Short-Form Health Survey (2)WHOQoL-BREF | compare between the beginning of the study and after 12 weeks of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, hyperlipidemia, green tea, epigallocatechin gallate