Clinical trial NCT02147041: The Effect of Extract of Green Tea on Obese Women and Obese Related Hormone Peptides
Official title: The Effect of Extract of Green Tea on Obese Women Obese Related Hormone Peptides
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus
Hyperlipidemia
Keywords: diabetes mellitus
hyperlipidemia
green tea
epigallocatechin gallate
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2014-05-26
Enrollment: 92
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: composite of anthropometric measures
timeFrame: compare between the beginning of the study and after 12 weeks of treatment.
Secondary outcomes:
measure: Hormone peptide change
timeFrame: compared between the beginning of the study and after 12 weeks of treatment
measure: biochemical characteristic change
timeFrame: compare between the beginning of the study and after 12 weeks of treatment.
measure: traditional chinese medicine syndrome classification
timeFrame: compare between the beginning of the study and after 12 weeks of treatment.
measure: Quality of life evaluation
timeFrame: compare between the beginning of the study and after 12 weeks of treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
affiliation: Taipei medical hospital, Linsen Chinese Medicine branch
name: Chung-Hua Hsu, PHD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.