Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT04692792
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2020-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Evaluation of Dai Dai Flower on Body Weight
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of body weight', 'timeFrame': 'Change from Baseline body weight at 8 weeks', 'description': 'The body weight (kg) was assessed by InBody.'}, {'measure': 'The change of BMI', 'timeFrame': 'Change from Baseline BMI at 8 weeks', 'description': 'The BMI was assessed by InBody.'}], 'secondaryOutcomes': [{'measure': 'The change of body fat mass', 'timeFrame': 'Change from Baseline body fat mass at 8 weeks', 'description': 'The body fat mass (kg) was assessed by InBody.'}, {'measure': 'The change of visceral fat mass', 'timeFrame': 'Change from Baseline visceral fat mass at 8 weeks', 'description': 'The visceral fat mass (kg) was assessed by InBody.'}, {'measure': 'The change of waist-hip ratio', 'timeFrame': 'Change from Baseline waist-hip ratio at 8 weeks', 'description': 'The waist-hip ratio was assessed by measuring tape.'}, {'measure': 'The change of basal metabolic rate', 'timeFrame': 'Change from Baseline basal metabolic rate at 8 weeks', 'description': 'The basal metabolic rate was assessed by InBody.'}, {'measure': 'The change of AST', 'timeFrame': 'Change from Baseline AST at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of aspartate transaminase (AST)'}, {'measure': 'The change of ALT', 'timeFrame': 'Change from Baseline ALT at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of alanine aminotransferase (ALT)'}, {'measure': 'The change of Creatinine', 'timeFrame': 'Change from Baseline creatinine at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of creatinine'}, {'measure': 'The change of BUN', 'timeFrame': 'Change from Baseline BUN at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of blood urea nitrogen (BUN)'}, {'measure': 'The change of fasting glycemia', 'timeFrame': 'Change from Baseline fasting glycemia at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of fasting glycemia'}, {'measure': 'The change of total cholesterol', 'timeFrame': 'Change from Baseline total cholesterol at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of total cholesterol'}, {'measure': 'The change of triglyceride', 'timeFrame': 'Change from Baseline triglyceride at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of triglyceride'}, {'measure': 'The change of HDL-cholesterol', 'timeFrame': 'Change from Baseline HDL-cholesterol at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of HDL-cholesterol'}, {'measure': 'The change of LDL-cholesterol', 'timeFrame': 'Change from Baseline LDL-cholesterol at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of LDL-cholesterol'}, {'measure': 'The change of insulin', 'timeFrame': 'Change from Baseline insulin at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of insulin'}, {'measure': 'The change of adiponectin', 'timeFrame': 'Change from Baseline adiponectin at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of adiponectin'}, {'measure': 'The change of leptin', 'timeFrame': 'Change from Baseline leptin at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of leptin'}, {'measure': 'The change of IFN-γ', 'timeFrame': 'Change from Baseline IFN-γ at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of IFN-γ'}, {'measure': 'The change of IL-2', 'timeFrame': 'Change from Baseline IL-2 at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of IL-2'}, {'measure': 'The change of IL-1beta', 'timeFrame': 'Change from Baseline IL-1beta at 8 weeks', 'description': 'Venous blood was sampled to measure concentrations of IL-1beta'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Weight control', 'Dai Dai flower'], 'conditions': ['Gastroenterology']}, 'descriptionModule': {'briefSummary': 'To assess the Dai Dai flower extract on body weight control'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female aged between 20 and 60 years old\n* Body mass index (BMI) ≥ 24 (kg/m\\^2) or body fat mass ≥ 25%\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Implementation in weight loss programs, consumption drugs or supplements for weight control before 3 months of this study\n* Participate weight control or fat loss human studies before 3 months of this study\n* History of cardiovascular disease, liver disease, kidney disease, endocrine disease, or other major organic diseases (according to subjects reporting).\n* Person who has received major surgery or bariatric surgery (according to medical history).\n* Person who has received constant drug use.\n* People with mental illness'}, 'identificationModule': {'nctId': 'NCT04692792', 'briefTitle': 'Efficacy Evaluation of Dai Dai Flower on Body Weight', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Efficacy Evaluation of Dai Dai Flower on Body Weight', 'orgStudyIdInfo': {'id': 'CMUH109-REC1-161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drink', 'interventionNames': ['Dietary Supplement: Placebo drink']}, {'type': 'EXPERIMENTAL', 'label': 'Dai Dai flower drink', 'interventionNames': ['Dietary Supplement: Dai Dai flower drink']}], 'interventions': [{'name': 'Placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 bottle (50 mL) per day for 8 weeks', 'armGroupLabels': ['Placebo drink']}, {'name': 'Dai Dai flower drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 bottle (50 mL) per day for 8 weeks', 'armGroupLabels': ['Dai Dai flower drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Hsiu-Mei Chiang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}