Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT03260751
Status:
COMPLETED
Last Update Posted:
2019-05-09
First Post:
2017-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-07', 'studyFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2017-08-22', 'lastUpdatePostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of body fat mass', 'timeFrame': 'Baseline and 12 week', 'description': 'Body fat mass was measured in study baseline and 12 week'}], 'secondaryOutcomes': [{'measure': 'Changes of percent body fat', 'timeFrame': 'Baseline and 12 week', 'description': 'Percent body fat was measured in study baseline and 12 week'}, {'measure': 'Changes of fat free mass', 'timeFrame': 'Baseline and 12 week', 'description': 'Fat Free Mass was measured in study baseline and 12 week'}, {'measure': 'Changes of weight', 'timeFrame': 'Baseline and 12 week', 'description': 'Weight was measured in study baseline and 12 week'}, {'measure': 'Changes of body mass index', 'timeFrame': 'Baseline and 12 week', 'description': 'Body mass index was measured in study baseline and 12 week'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study was conducted to investigate the effects of daily supplementation of Zingiber officinale Roscoe extract on body fat.', 'detailedDescription': 'This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into Zingiber officinale Roscoe extract 200 mg or placebo group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 19 and 65 years,\n* BMI 25\\~29.9 kg/m2\n* subjects giving written informed consent\n\nExclusion Criteria:\n\n* Significant variation in weight(more 10%) in the past 3 months\n* Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker\n* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery\n* Participation in any other clinical trials within past 2 months\n* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study\n* Pregnancy or breast feeding etc,.'}, 'identificationModule': {'nctId': 'NCT03260751', 'briefTitle': 'Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat', 'orgStudyIdInfo': {'id': 'WJ-BF-ZO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zingiber officinale Roscoe extract 200 mg', 'description': '2 cap/day, 800 mg/cap for 12 weeks', 'interventionNames': ['Dietary Supplement: Zingiber officinale Roscoe extract 200 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for 12 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Zingiber officinale Roscoe extract 200 mg', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 cap/day, 800 mg/cap for 12 weeks', 'armGroupLabels': ['Zingiber officinale Roscoe extract 200 mg']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54907', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Clinical Trial Center for Functional Foods Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Clinical Trial Center for Functional Foods', 'investigatorFullName': 'Soo-Wan Chae', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}