Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-26 @ 7:13 PM
Study NCT ID:
NCT00631293
Status:
COMPLETED
Last Update Posted:
2009-04-07
First Post:
2008-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effect of Lactisole on the Intestinal Glucose Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C495512', 'term': 'lactisole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-06', 'studyFirstSubmitDate': '2008-02-26', 'studyFirstSubmitQcDate': '2008-02-27', 'lastUpdatePostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in glucose uptake rate in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test', 'timeFrame': '5 weeks'}], 'secondaryOutcomes': [{'measure': 'Differences in blood insulin, glucagon, triglycerides, GIP and GLP-1 in lactisole treated subjects versus placebo treated subjects during oral glucose tolerance test, ECG', 'timeFrame': '5 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study of the effect of lactisole on glucose uptake'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subject, between 18 and 50 years\n* General good health condition\n\nExclusion Criteria:\n\n* Overweight (Body Mass Index ≥30)\n* Metabolic disorders\n* History of gastrointestinal disorders\n* Regular (daily) intake of medication\n* Smoking more than 10 cigarettes/day\n* History of drug abuse\n* Exhaustive (\\> 3 units/day) alcohol consumption\n* Exhaustive (\\> 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)\n* Recent (in the last 14 days) donation of blood\n* Recent (in the last 2 days) donation of blood plasma\n* Participation in another trial within 4 weeks before the start of the study'}, 'identificationModule': {'nctId': 'NCT00631293', 'briefTitle': 'Study of the Effect of Lactisole on the Intestinal Glucose Uptake', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Study on the Effect of Lactisole on the Intestinal Glucose Uptake', 'orgStudyIdInfo': {'id': '2008/103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'administration of lactisole', 'interventionNames': ['Dietary Supplement: lactisole']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'administration of placebo', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'lactisole', 'type': 'DIETARY_SUPPLEMENT', 'description': 'administration of lactisole followed by placebo', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'administration of placebo followed by lactisole', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Luc Van Bortel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'VIB', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dirk Iserentant, PhD', 'oldOrganization': 'University Ghent'}}}}