Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-04 @ 9:20 PM
Study NCT ID:
NCT01687569
Status:
COMPLETED
Last Update Posted:
2013-05-09
First Post:
2012-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycaemic Responses to Cracker Snacks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-07', 'studyFirstSubmitDate': '2012-09-14', 'studyFirstSubmitQcDate': '2012-09-14', 'lastUpdatePostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycaemic Response(s) to cracker snacks as measured by incremental Area Under the Curve (iAUC)', 'timeFrame': '120 minutes', 'description': 'The endpoint will be the blood glucose response curve, calculated from the individual glucose measurements. Evaluated by repeated measures ANOVA on incremental AUC measured in capillary blood.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glycaemic Response'], 'conditions': ['Glycaemic Response Measurements']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack.'}, '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% Male)\n* Aged 18 - 55 years\n* Non Smokers\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 wheat, mustard, dairy, or soy\n* Have a fasting plasma glucose (finger-stick) \\<100 mg/dl (\\<5.5 mmol/L)\n* Willing and able to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT01687569', 'briefTitle': 'Glycaemic Responses to Cracker Snacks', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mondelēz International, Inc.'}, 'officialTitle': 'Effects of Added Spice Flour on Glycaemic Responses to a Cracker Snack', 'orgStudyIdInfo': {'id': 'P12-05774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Cracker', 'description': 'Base cracker snack', 'interventionNames': ['Other: Control Cracker Snack']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Cracker Snack 1', 'description': 'Cracker snack containing test ingredient 1', 'interventionNames': ['Other: Experimental Cracker Snack 1']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Cracker Snack 2', 'description': 'Cracker snack containing test ingredient 2', 'interventionNames': ['Other: Experimental Cracker Snack 2']}], 'interventions': [{'name': 'Control Cracker Snack', 'type': 'OTHER', 'description': 'Base cracker snack', 'armGroupLabels': ['Control Cracker']}, {'name': 'Experimental Cracker Snack 1', 'type': 'OTHER', 'description': 'Cracker snack containing test ingredient 1', 'armGroupLabels': ['Experimental Cracker Snack 1']}, {'name': 'Experimental Cracker Snack 2', 'type': 'OTHER', 'description': 'Cracker snack containing test ingredient 2', 'armGroupLabels': ['Experimental Cracker Snack 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reading', 'country': 'United Kingdom', 'facility': 'Reading Scientific Services Limited (RSSL)', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Rungano Munyuki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reading Scientific Services Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mondelēz International, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Reading Scientific Services Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}