Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT00383058
Status:
COMPLETED
Last Update Posted:
2009-09-01
First Post:
2006-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-31', 'studyFirstSubmitDate': '2006-09-29', 'studyFirstSubmitQcDate': '2006-09-29', 'lastUpdatePostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(Percent) reduction of body mass index and body weight'}], 'secondaryOutcomes': [{'measure': '(Percent) reduction of: Glucose, cholesterol,LDL, HDL and triglyceride'}, {'measure': 'leptin, adiponectin and ghrelin comparisons and analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obesity', 'green tea'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '18468736', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.nature.com/ijo/journal/v29/n11/abs/0802997a.html', 'label': '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', 'label': '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', 'label': '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', 'label': 'study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether the extract of the green tea is effective on obese women.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 16-60 years old female\n2. BMI\\>27㎞/m2\n3. Signed informed consent\n\nExclusion Criteria:\n\n1. Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.\n2. Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.\n3. Allergy and Immunology disease.\n4. High aminotransferases ( Alanine, Aspartate \\>80 IU/L) or high serum Creatinine (\\>2.5 mg/dL)\n5. Pregnant or lactating women.\n6. Childbirth within 6 months.\n7. Stroke or otherwise unable to exercise\n8. Management for weight control within 3 months.\n9. Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.'}, 'identificationModule': {'nctId': 'NCT00383058', 'briefTitle': 'The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei City Hospital'}, 'officialTitle': 'The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial', 'orgStudyIdInfo': {'id': 'TH-Greentea-06-01'}, 'secondaryIdInfos': [{'id': 'NSC-95-2320-B-192-001'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'the extract of green tea', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chung-Hua Hsu, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese Medicine Dep, Taipei Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei City Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}, {'name': 'Taipei Hospital, Taiwan', 'class': 'OTHER'}]}}}