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

This study has been completed.
Sponsor:
Collaborators:
National Science Council, Taiwan
Taipei Hospital, Taiwan
Information provided by:
Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT00383058
First received: September 29, 2006
Last updated: August 31, 2009
Last verified: August 2009
History of Changes
  Purpose

The purpose of this study is to examine whether the extract of the green tea is effective on obese women.


Condition Intervention Phase
Obesity
 Drug: the extract of green tea
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Taipei City Hospital:

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

Estimated Enrollment: 100
Study Start Date: September 2006
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383058

Locations
Taiwan
Taipei Hospital
Taipei, Taiwan, 886
Sponsors and Collaborators
Taipei City Hospital
National Science Council, Taiwan
Taipei Hospital, Taiwan
Investigators
Study Director: Chung-Hua Hsu, MD, PhD Chinese Medicine Dep, Taipei Hospital
  More Information

Additional Information:
Taipei hospital  This link exits the ClinicalTrials.gov site
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No publications provided by Taipei City Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00383058     History of Changes
Other Study ID Numbers: TH-Greentea-06-01, NSC-95-2320-B-192-001
Study First Received: September 29, 2006
Last Updated: August 31, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei City Hospital:
obesity
green tea

Additional relevant MeSH terms:
Obesity
Blindness
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013