Diabetes Mellitus, Hyperlipidemia
Conditions
Keywords
diabetes mellitus, hyperlipidemia, green tea, epigallocatechin gallate
Brief summary
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
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.
Interventions
DRUGEGCG(Epigallocatechin Gallate)
500mg, three times a day, duration:12 weeks
DRUGPlacebo
Sponsors
National Yang Ming Chiao Tung University
Taipei City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite of anthropometric measures | compare between the beginning of the study and after 12 weeks of treatment. | composite include body weight, waist circumference, hip circumference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hormone peptide change | 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 |
| biochemical characteristic change | compare between the beginning of the study and after 12 weeks of treatment. | blood sugar, creatinine, aminotransferases aspartate, aminotransferases alanine, uric acid and |
| traditional chinese medicine syndrome classification | compare between the beginning of the study and after 12 weeks of treatment. | Use questionaire to classify traditional chinese medicine syndrome in obese women |
| Quality of life evaluation | compare between the beginning of the study and after 12 weeks of treatment. | (1)12-item Short-Form Health Survey (2)WHOQoL-BREF |
Countries
Taiwan
Outcome results
None listed