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

Primary Purpose

Diabetes Mellitus, Hyperlipidemia

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
EGCG(Epigallocatechin Gallate)
Placebo
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring diabetes mellitus, hyperlipidemia, green tea, epigallocatechin gallate

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EGCG(Epigallocatechin Gallate)

placebo

Arm Description

EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks)

cellulose (500mg, three times a day, 12 weeks)

Outcomes

Primary Outcome Measures

composite of anthropometric measures
composite include body weight, waist circumference, hip circumference

Secondary Outcome Measures

Hormone peptide change
hormone peptides such as leptin、adiponectin、ghrelin、fasting insulin resistance、APOB、APOA1
biochemical characteristic change
blood sugar, creatinine, aminotransferases aspartate, aminotransferases alanine, uric acid and
traditional chinese medicine syndrome classification
Use questionaire to classify traditional chinese medicine syndrome in obese women
Quality of life evaluation
(1)12-item Short-Form Health Survey (2)WHOQoL-BREF

Full Information

First Posted
January 20, 2014
Last Updated
May 21, 2014
Sponsor
Taipei City Hospital
Collaborators
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT02147041
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei City Hospital
Collaborators
National Yang Ming University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hyperlipidemia
Keywords
diabetes mellitus, hyperlipidemia, green tea, epigallocatechin gallate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EGCG(Epigallocatechin Gallate)
Arm Type
Experimental
Arm Description
EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
cellulose (500mg, three times a day, 12 weeks)
Intervention Type
Drug
Intervention Name(s)
EGCG(Epigallocatechin Gallate)
Other Intervention Name(s)
EGCG-Epigallocatechin Gallate, green tea extract, cellulose-cellulose
Intervention Description
500mg, three times a day, duration:12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
composite of anthropometric measures
Description
composite include body weight, waist circumference, hip circumference
Time Frame
compare between the beginning of the study and after 12 weeks of treatment.
Secondary Outcome Measure Information:
Title
Hormone peptide change
Description
hormone peptides such as leptin、adiponectin、ghrelin、fasting insulin resistance、APOB、APOA1
Time Frame
compared between the beginning of the study and after 12 weeks of treatment
Title
biochemical characteristic change
Description
blood sugar, creatinine, aminotransferases aspartate, aminotransferases alanine, uric acid and
Time Frame
compare between the beginning of the study and after 12 weeks of treatment.
Title
traditional chinese medicine syndrome classification
Description
Use questionaire to classify traditional chinese medicine syndrome in obese women
Time Frame
compare between the beginning of the study and after 12 weeks of treatment.
Title
Quality of life evaluation
Description
(1)12-item Short-Form Health Survey (2)WHOQoL-BREF
Time Frame
compare between the beginning of the study and after 12 weeks of treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-Hua Hsu, PHD
Organizational Affiliation
Taipei medical hospital, Linsen Chinese Medicine branch
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18468736
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.
Results Reference
result
PubMed Identifier
26093535
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.
Results Reference
derived

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

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