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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02147041
• Other study ID #: 100XDAA00110
• Secondary ID: 100XDAA00110
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: January 20, 2014
• Last updated: May 21, 2014
• Start date: May 2012
• Est. completion date: August 2014

Study information

• Verified date: May 2014
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 92
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• EGCG(Epigallocatechin Gallate)
500mg, three times a day, duration:12 weeks
• Placebo

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei City Hospital	National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes