Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT06203834
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2024-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-25', 'studyFirstSubmitDate': '2024-01-03', 'studyFirstSubmitQcDate': '2024-01-03', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline body weight at week 12', 'timeFrame': 'Week 0, Week 12', 'description': 'Compared the difference of body weight between the week 12 and 0.'}, {'measure': 'Change from baseline body fat at week 12', 'timeFrame': 'Week 0, Week 12', 'description': 'Compared the difference of body fat between the week 12 and 0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults.', 'detailedDescription': 'This randomized, double-blinded,placebo-controlled clinical trial will be conduct for 12 weeks with fifty adults. Subjects will be recruited and randomly assigned into two groups: (1) placebo, n = 25; (2) I-Fiber Pearl, n=25. During the 12 weeks intervention, the subjects should take 200g placebo or 200g I-Fiber Pearl a day . The two pearl are supplied in plastic packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, urine, feces and blood collection at week 0 and week 12.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* aged 20-50 years old\n* body mass index is greater than or equal to 27 kg/m2\n* waist greater than or equal to 80 cm\n\nExclusion Criteria:\n\n* Subjects diagnosed with cancer and on curative care.\n* Subjects diagnosed with heart disease and on curative care.\n* Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug.\n* Subjects with systemic infection requiring antibiotics.'}, 'identificationModule': {'nctId': 'NCT06203834', 'briefTitle': 'Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects: a Randomized, Double-blind, and Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'CS2-23093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo 200g, without any ingredients of inulin fiber. Eat 200g for once, and once a day.', 'interventionNames': ['Dietary Supplement: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'I-Fiber Pearl', 'description': 'I-Fiber Pearl 200g, with inulin fiber. Eat 200g for once, and once a day.', 'interventionNames': ['Dietary Supplement: I-Fiber Pearl']}], 'interventions': [{'name': 'I-Fiber Pearl', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eat 200g for once, and once a day.', 'armGroupLabels': ['I-Fiber Pearl']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eat 200g for once, and once a day.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402', 'city': 'Taichung', 'state': 'South', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Chin-Lin Hsu, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Chung Shan Medical University'}, {'name': 'Chin-Lin Hsu, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}, {'name': 'Shiuan-Chih Chen, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}, {'name': 'Hung-Hsuan Kuo, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}, {'name': 'Chun-Tse Tsai, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'ITSWAY BIOTECH INC.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chin-Lin Hsu', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}