Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT05542160
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2022-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of IRK-19® on Body Weight Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anthropometric measurement', 'timeFrame': 'Week 0', 'description': 'Body weight'}, {'measure': 'Anthropometric measurement', 'timeFrame': 'Week 6', 'description': 'Body weight'}, {'measure': 'Anthropometric measurement', 'timeFrame': 'Week 12', 'description': 'Body weight'}, {'measure': 'Anthropometric measurement', 'timeFrame': 'Week 0', 'description': 'Waist circumference'}, {'measure': 'Anthropometric measurement', 'timeFrame': 'Week 6', 'description': 'Waist circumference'}, {'measure': 'Anthropometric measurement', 'timeFrame': 'Week 12', 'description': 'Waist circumference'}, {'measure': 'Anthropometric measurement', 'timeFrame': 'Week 0', 'description': 'Hip circumference'}, {'measure': 'Anthropometric measurement', 'timeFrame': 'Week 6', 'description': 'Hip circumference'}, {'measure': 'Anthropometric measurement', 'timeFrame': 'Week 12', 'description': 'Hip circumference'}, {'measure': 'Body composition analysis', 'timeFrame': 'Week 0', 'description': 'Body fat'}, {'measure': 'Body composition analysis', 'timeFrame': 'Week 6', 'description': 'Body fat'}, {'measure': 'Body composition analysis', 'timeFrame': 'Week 12', 'description': 'Body fat'}, {'measure': 'Body composition analysis', 'timeFrame': 'Week 0', 'description': 'Visceral fat'}, {'measure': 'Body composition analysis', 'timeFrame': 'Week 6', 'description': 'Visceral fat'}, {'measure': 'Body composition analysis', 'timeFrame': 'Week 12', 'description': 'Visceral fat'}, {'measure': 'Body composition analysis', 'timeFrame': 'Week 0', 'description': 'Subcutaneous fat'}, {'measure': 'Body composition analysis', 'timeFrame': 'Week 6', 'description': 'Subcutaneous fat'}, {'measure': 'Body composition analysis', 'timeFrame': 'Week 12', 'description': 'Subcutaneous fat'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 0', 'description': 'Total cholesterol'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 6', 'description': 'Total cholesterol'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 12', 'description': 'Total cholesterol'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 0', 'description': 'Triacylglycerol'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 6', 'description': 'Triacylglycerol'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 12', 'description': 'Triacylglycerol'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 0', 'description': 'HDL'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 6', 'description': 'HDL'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 12', 'description': 'HDL'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 0', 'description': 'LDL'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 6', 'description': 'LDL'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 12', 'description': 'LDL'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 0', 'description': 'Adiponectin'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 6', 'description': 'Adiponectin'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 12', 'description': 'Adiponectin'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 0', 'description': 'Lectin'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 6', 'description': 'Lectin'}, {'measure': 'Biochemistry', 'timeFrame': 'Weeks 12', 'description': 'Lectin'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 0', 'description': 'Fasting blood glucose'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 6', 'description': 'Fasting blood glucose'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 12', 'description': 'Fasting blood glucose'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 0', 'description': 'Insulin'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 6', 'description': 'Insulin'}, {'measure': 'Biochemistry', 'timeFrame': 'Week 12', 'description': 'Insulin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract (IRK-19®) on weight management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. BMI: 25-30 kg/m2\n2. Waistline circumference: ˃ 80 cm\n\nExclusion Criteria:\n\n1. Pregnant women or preparing for pregnancy.\n2. Lactating women.\n3. Women gave birth 6 months before the study.\n4. Subject uses diuretic, corticosteroids, anti-depressant medications, or antipsychotic medications.\n5. Subject has undertaken obesity-related surgeries within one year prior to the study or other surgeries within six months prior to the study.\n6. Change of body weight of subject is over 5% within 3 months before the study.\n7. Subject has serious diseases (e.g., cardiovascular diseases).\n8. Cancer patient.\n9. Subject has engaged in another study within 3 months before the study.\n10. Subject uses another dietary supplement related to weight management during the study.'}, 'identificationModule': {'nctId': 'NCT05542160', 'briefTitle': 'Effectiveness of IRK-19® on Body Weight Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'Greenyn Biotechnology Co., Ltd.'}, 'officialTitle': 'Effectiveness of IRK-19® on Body Weight Control', 'orgStudyIdInfo': {'id': 'G-CAZ0040161110628-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule', 'interventionNames': ['Dietary Supplement: Pumpkin seed extract (IRK-19)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'IRK-19 capsule', 'interventionNames': ['Dietary Supplement: Pumpkin seed extract (IRK-19)']}], 'interventions': [{'name': 'Pumpkin seed extract (IRK-19)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo: Dietary fiber powder, two capsules/day (600 mg/day), continued use for 3 months Treatment: Pumpkin seed extract powder, two capsules/day (600 mg/day), continued use for 3 months', 'armGroupLabels': ['Placebo', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'WanFang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yen-Nung Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WanFang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Greenyn Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}