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

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ClinicalTrials.gov Identifier: NCT02147041
Recruitment Status : Unknown
Verified May 2014 by Chung-Hua Hsu, Taipei City Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 26, 2014
Last Update Posted : May 26, 2014
Sponsor:
Collaborator:
National Yang Ming University
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hyperlipidemia Drug: EGCG(Epigallocatechin Gallate) Drug: Placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Extract of Green Tea on Obese Women Obese Related Hormone Peptides
Study Start Date : May 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: EGCG(Epigallocatechin Gallate)
EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks)
Drug: EGCG(Epigallocatechin Gallate)
500mg, three times a day, duration:12 weeks
Other Names:
  • EGCG-Epigallocatechin Gallate, green tea extract
  • cellulose-cellulose

Placebo Comparator: placebo
cellulose (500mg, three times a day, 12 weeks)
Drug: Placebo



Primary Outcome Measures :
  1. composite of anthropometric measures [ Time Frame: compare between the beginning of the study and after 12 weeks of treatment. ]
    composite include body weight, waist circumference, hip circumference


Secondary Outcome Measures :
  1. Hormone peptide change [ Time Frame: 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

  2. biochemical characteristic change [ Time Frame: compare between the beginning of the study and after 12 weeks of treatment. ]
    blood sugar, creatinine, aminotransferases aspartate, aminotransferases alanine, uric acid and

  3. traditional chinese medicine syndrome classification [ Time Frame: compare between the beginning of the study and after 12 weeks of treatment. ]
    Use questionaire to classify traditional chinese medicine syndrome in obese women

  4. Quality of life evaluation [ Time Frame: compare between the beginning of the study and after 12 weeks of treatment. ]
    (1)12-item Short-Form Health Survey (2)WHOQoL-BREF



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147041


Locations
Taiwan
Taipei City Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei City Hospital
National Yang Ming University
Investigators
Study Chair: Chung-Hua Hsu, PHD Taipei medical hospital, Linsen Chinese Medicine branch

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chung-Hua Hsu, Chairman of medical affairs, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT02147041     History of Changes
Other Study ID Numbers: 100XDAA00110
100XDAA00110 ( Other Grant/Funding Number: 100XDAA00110 )
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: May 2014

Keywords provided by Chung-Hua Hsu, Taipei City Hospital:
diabetes mellitus
hyperlipidemia
green tea
epigallocatechin gallate

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperlipidemias
Hyperlipoproteinemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Hormones
Epigallocatechin gallate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents