The Effect of Extract of Green Tea on Obese Women Obese Related Hormone Peptides
试验速览
- 阶段
- 2 期
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- composite of anthropometric measures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged between 20 and 60 years old women
- •body mass index (BMI) > 27 kg/m2
- •waist circumference (WC) > 80 cm
- •willing to participate in and fill out the questionnaires for this trial.
排除标准
- •GPT > 80 U/L, serum creatinine > 2.0 mg/dl
- •breast feeding or pregnancy
- •heart failure
- •acute myocardial infarction
- •any other conditions not suitable for trial as evaluated by the physician
研究组 & 干预措施
EGCG(Epigallocatechin Gallate)
EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks)
干预措施: EGCG(Epigallocatechin Gallate) (Drug)
placebo
cellulose (500mg, three times a day, 12 weeks)
干预措施: Placebo (Drug)
结局指标
主要结局
composite of anthropometric measures
时间窗: compare between the beginning of the study and after 12 weeks of treatment.
composite include body weight, waist circumference, hip circumference
次要结局
- biochemical characteristic change(compare between the beginning of the study and after 12 weeks of treatment.)
- Hormone peptide change(compared between the beginning of the study and after 12 weeks of treatment)
- Quality of life evaluation(compare between the beginning of the study and after 12 weeks of treatment.)
- traditional chinese medicine syndrome classification(compare between the beginning of the study and after 12 weeks of treatment.)
研究者
Chung-Hua Hsu
Chairman of medical affairs
Taipei City Hospital