Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-01 @ 9:27 PM
Study NCT ID:
NCT00880958
Status:
COMPLETED
Last Update Posted:
2009-10-29
First Post:
2009-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity
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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-28', 'studyFirstSubmitDate': '2009-04-13', 'studyFirstSubmitQcDate': '2009-04-13', 'lastUpdatePostDateStruct': {'date': '2009-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body mass index', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Body fat mass', 'timeFrame': 'Week -4, Week 0, Week 4, Week 12'}, {'measure': 'Abdominal circumference', 'timeFrame': 'Week -4, Week 0, Week 4, Week 12'}, {'measure': 'Visceral fat area by CT scan', 'timeFrame': 'Week 0, Week 12'}, {'measure': 'Intestinal flora', 'timeFrame': 'Week 0, Week 12'}, {'measure': 'Serum lipid profile', 'timeFrame': 'Week -4, Week 0, Week 4, Week 12'}, {'measure': 'Serum adiponectin and leptin levels', 'timeFrame': 'Week 0, Week 12'}, {'measure': 'Fasting serum glucose and HbA1c levels', 'timeFrame': 'Week -4, Week 0, Week 4, Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy as based on medical history and physical examination\n* BMI between 25 and 30 kg/m2\n* Willing not to serve as blood donor during the study\n* Informed consent signed\n\nExclusion Criteria:\n\n* Food allergy\n* Female subjects who are pregnant or nursing a child\n* Participation in any clinical trial up to 90 days before Day 01 of this study\n* Renal or hepatic dysfunction\n* Heart disease\n* Under medication\n* Subjects who are taking functional food designed for weight loss or serum lipid reduction'}, 'identificationModule': {'nctId': 'NCT00880958', 'briefTitle': 'Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Hiroshima University'}, 'officialTitle': 'Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity: a Double-Blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'eki-123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Dietary Supplement: Mixture of various probiotics and fermentation products']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Mixture of various probiotics and fermentation products', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '734-8551', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hiroshima University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biostir, Inc.', 'class': 'INDUSTRY'}, {'name': 'MIONA Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Fumiko Higashikawa, PhD/Associate professor', 'oldOrganization': 'Hiroshima University'}}}}