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| ID | Type | Description | Link |
|---|---|---|---|
| 100XDAA00110 | Other Grant/Funding Number | 100XDAA00110 |
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| Name | Class |
|---|---|
| National Yang Ming Chiao Tung University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGCG(Epigallocatechin Gallate) | Experimental | EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks) |
|
| placebo | Placebo Comparator | cellulose (500mg, three times a day, 12 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGCG(Epigallocatechin Gallate) | Drug | 500mg, three times a day, duration:12 weeks |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chung-Hua Hsu, PHD | Taipei medical hospital, Linsen Chinese Medicine branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei City Hospital | Taipei | Taiwan | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18468736 | Result | Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12. | |
| 26093535 | Derived | Chen IJ, Liu CY, Chiu JP, Hsu CH. Therapeutic effect of high-dose green tea extract on weight reduction: A randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2016 Jun;35(3):592-9. doi: 10.1016/j.clnu.2015.05.003. Epub 2015 May 29. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013662 | Tea |
| D002482 | Cellulose |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| Placebo | Drug |
|
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. |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |