Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT01536860
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2012-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Glycemic Response Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rungano.munyuki@rssl.com', 'phone': '+44 118 918 4166', 'title': 'Rungano Munyuki', 'organization': 'RSSL'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Test Drink', 'description': 'Control Drink\n\nDietary Intervention : 300 ml of liquid food product', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental Test Drink 1', 'description': 'Control Drink containing ingredient 1\n\nDietary Intervention : 300 ml of liquid food product', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Experimental Test Drink 2', 'description': 'Control Drink containing ingredient 2\n\nDietary Intervention : 300 ml of liquid food product', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Test Drink', 'description': 'Control Drink\n\nDietary Intervention : 300 ml of liquid food product'}, {'id': 'OG001', 'title': 'Experimental Test Drink 1', 'description': 'Control Drink containing ingredient 1\n\nDietary Intervention : 300 ml of liquid food product'}, {'id': 'OG002', 'title': 'Experimental Test Drink 2', 'description': 'Control Drink containing ingredient 2\n\nDietary Intervention : 300 ml of liquid food product'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'spread': '17', 'groupId': 'OG000'}, {'value': '68', 'spread': '10', 'groupId': 'OG001'}, {'value': '73', 'spread': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-120 minutes', 'description': 'The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.', 'unitOfMeasure': 'mmol*min/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Test Drink/Exp Test Drink 1/Exp Test Drink 2', 'description': 'Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.\n\nConsume Exp Test Drink 1 followed by a 3 day wash out period. Consume Exp Test Drink 2 over a 15 minute period'}, {'id': 'FG001', 'title': 'Exp Test Drink 1/Control Test Drink/Exp Test Drink 2', 'description': 'Consume Exp Test Drink 1 once over a 15 minute period followed by a 3 day wash out period.\n\nConsume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.\n\nConsume Exp Test Drink 2 once over a 15 minute period.'}, {'id': 'FG002', 'title': 'Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1', 'description': 'Consume Exp Test Drink 2 once over a 15 minute period followed by a 3 day wash out period.\n\nConsume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.\n\nConsume Exp Test Drink 1 once over a 15 minute period.'}], 'periods': [{'title': 'First Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 11 subjects completed the study. The study was conducted at one clinical research site and study started February, 2012 and was completed in March 2012.', 'preAssignmentDetails': 'This was a randomized double blind cross-over study. There was a wash out period of 3 or more days between interventions.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes groups randomized to receive Control Test Drink first, Exp Test Drink 1 first and Exp Test Drink 2 first.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2012-02-16', 'resultsFirstSubmitDate': '2012-09-11', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-05', 'studyFirstPostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products', 'timeFrame': '0-120 minutes', 'description': 'The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glycemic Index', 'Glycemic Response']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female (not less than 40% males or females\n* Non-smoker\n* Aged 18 to 55 years\n* Have a body mass index between 18.5 to 29.99 kg/m2\n* Healthy, non-diabetic, no gastric bypass surgery\n* Not allergic to mustard, dairy or soy\n* Having a fasting plasma glucose (finger stick) \\<100 mg/dl (\\<5.5 mmol/L)\n* Willing and able to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT01536860', 'briefTitle': 'Glycemic Response Testing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mondelēz International, Inc.'}, 'officialTitle': 'Glycaemic Response Testing', 'orgStudyIdInfo': {'id': 'P12-00794'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Test Drink', 'description': 'control drink', 'interventionNames': ['Other: Dietary Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Test Drink 1', 'description': 'control drink containing ingredient 1', 'interventionNames': ['Other: Dietary Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Test Drink 2', 'description': 'Control drink containing ingredient 2', 'interventionNames': ['Other: Dietary Intervention']}], 'interventions': [{'name': 'Dietary Intervention', 'type': 'OTHER', 'description': '300 ml of liquid food product', 'armGroupLabels': ['Control Test Drink']}, {'name': 'Dietary Intervention', 'type': 'OTHER', 'description': '300 ml of liquid food product', 'armGroupLabels': ['Experimental Test Drink 1']}, {'name': 'Dietary Intervention', 'type': 'OTHER', 'description': '300 ml of liquid food product', 'armGroupLabels': ['Experimental Test Drink 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG6 6BZ', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Reading Scientific Services Limited (RSSL)', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Valerie Hart, SCS, Dip, MICR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RSSL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mondelēz International, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Reading Scientific Services Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}