Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT06609603
Status:
RECRUITING
Last Update Posted:
2024-09-24
First Post:
2024-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Body Fat Reducing Effects of Heat-Treated Green Tea Extract Complex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-19', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of body fat by DEXA', 'timeFrame': 'Baseline, Week 12', 'description': 'Measurement was made by using dual-energy X-ray absorption(DEXA)'}], 'secondaryOutcomes': [{'measure': 'Changes of total abdominal fat area, visceral fat area and subcutaneous fat area', 'timeFrame': 'Baseline, Week 12', 'description': 'Measurement of the target area is made using computed tomography'}, {'measure': 'Changes of indicator of lipid metabolism', 'timeFrame': 'Baseline, Week 12', 'description': 'indicator of lipid metabolism (i.e., TC, TG, HDL, LDL)'}, {'measure': 'Changes of waist circumference', 'timeFrame': 'Baseline, Week 12', 'description': 'Measurement of waist circumfernece was performed in accordance with WHO guideline'}, {'measure': 'Changes of blood biomarker', 'timeFrame': 'Baseline, Week 12', 'description': 'adiponectin, etc.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Fat']}, 'descriptionModule': {'briefSummary': 'This clinical study was designed to evaluate the efficacy and safety of body fat reduction in obese adults by treatment of heat-treated green tea extract complex', 'detailedDescription': 'This study is a 12-week, randomized, double-blind, placebo-controlled clinical trial. 100 subjects were ranromly assigned to heat-treated green tea extract(HTGT) group and placebo group. The changes in the efficacy endpoint were evaluated after treatment of 2 capsules of HTGT once daiy for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* lt;Inclusion Criteria\\>\n\n * Males and females aged between 19 \\~ 64 years\n * BMI 25.0 \\~ 34.9 kg/m\\^2\n * Waist circumferebce: 90cm or more for men, 85cm or more for women\n * Subjects who have fully understand the information provided about the study and voluntarily decided to participate\n* lt;Exclusion Criteria\\>\n\n * Participants whose weight changed by more than 10% within the 3 months prior to visit 1\n * Individuals participated in a commercial weight loss program within 3 months prior to Visit 1\n * Participants who have undergone surgical procedures within 3 years\n * Participants who have taken obesity treatment medications within the last 3 months\n * Individuals who have taken medications affecting weight or dietary supplements for weight control within the last month\n * Subjects with uncontrolled hypertension\n * Subjects diagnosed with diabetes\n * TSH \\<0.1 uIU/ml or \\>10 uIU/ml\n * Creatinine \\>1.5mg/dL\n * AST or ALT \\> three times the upper normal limit'}, 'identificationModule': {'nctId': 'NCT06609603', 'briefTitle': 'Clinical Study to Evaluate the Body Fat Reducing Effects of Heat-Treated Green Tea Extract Complex', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amorepacific Corporation'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect of Heat-Treated Green Tea Extract Complex', 'orgStudyIdInfo': {'id': 'AP-PV-2023-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HTGT compound', 'description': '* Dietary supplement: HTGT compound\n\n * oral administration of HTGT compound once daily, 2 capsules per day.\n* Dietary supplement; Placebo\n\n * oral administration of placebo once daily, 2 canpules per day', 'interventionNames': ['Dietary Supplement: HTGT compound']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Once daily, 2 capsules per day', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'HTGT compound', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral administration of HTGT compound once daily', 'armGroupLabels': ['HTGT compound']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration of placebo once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Wook Song, M.D./Ph.D.', 'role': 'CONTACT', 'email': 'fmssw@catholic.ac.kr', 'phone': '82-31-881-8859'}], 'facility': 'Catholic University St. Vincent Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'Jonghee Sohn', 'role': 'CONTACT', 'email': 'sohnjh@amorepacific.com', 'phone': '800-555-5555'}, {'name': 'HyunJin Nam, Ph.D.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Sang-Wook Song, M.D./Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University St. Vincent Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amorepacific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}