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The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial

Primary Purpose

Obesity

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
the extract of green tea
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, green tea

Eligibility Criteria

16 Years - 60 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 16-60 years old female
  2. BMI>27㎞/m2
  3. Signed informed consent

Exclusion Criteria:

  1. Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
  2. Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.
  3. Allergy and Immunology disease.
  4. High aminotransferases ( Alanine, Aspartate >80 IU/L) or high serum Creatinine (>2.5 mg/dL)
  5. Pregnant or lactating women.
  6. Childbirth within 6 months.
  7. Stroke or otherwise unable to exercise
  8. Management for weight control within 3 months.
  9. Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.

Sites / Locations

  • Taipei Hospital

Outcomes

Primary Outcome Measures

(Percent) reduction of body mass index and body weight

Secondary Outcome Measures

(Percent) reduction of: Glucose, cholesterol,LDL, HDL and triglyceride
leptin, adiponectin and ghrelin comparisons and analysis

Full Information

First Posted
September 29, 2006
Last Updated
August 31, 2009
Sponsor
Taipei City Hospital
Collaborators
National Science Council, Taiwan, Taipei Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00383058
Brief Title
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
Official Title
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Taipei City Hospital
Collaborators
National Science Council, Taiwan, Taipei Hospital, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine whether the extract of the green tea is effective on obese women.
Detailed Description
We conducted the pilot study in 2005. The initial findings showed the extract of green tea is benefit on obese women. The potential benefit include appetite lowing, lipid markers decreasing and regulating balance of obese related hormone peptides. So we designed this trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, green tea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
the extract of green tea
Primary Outcome Measure Information:
Title
(Percent) reduction of body mass index and body weight
Secondary Outcome Measure Information:
Title
(Percent) reduction of: Glucose, cholesterol,LDL, HDL and triglyceride
Title
leptin, adiponectin and ghrelin comparisons and analysis

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 16-60 years old female BMI>27㎞/m2 Signed informed consent Exclusion Criteria: Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder. Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker. Allergy and Immunology disease. High aminotransferases ( Alanine, Aspartate >80 IU/L) or high serum Creatinine (>2.5 mg/dL) Pregnant or lactating women. Childbirth within 6 months. Stroke or otherwise unable to exercise Management for weight control within 3 months. Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-Hua Hsu, MD, PhD
Organizational Affiliation
Chinese Medicine Dep, Taipei Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Hospital
City
Taipei
ZIP/Postal Code
886
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
derived
Links:
URL
http://www.nature.com/ijo/journal/v29/n11/abs/0802997a.html
Description
related research
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16076989&itool=iconfft&query_hl=2&itool=pubmed_docsum
Description
related research
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15976140&itool=iconfft&query_hl=2&itool=pubmed_docsum
Description
related study
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15738931&itool=iconabstr&query_hl=4&itool=pubmed_docsum
Description
study

Learn more about this trial

The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial

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