Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT01341769
Status:
WITHDRAWN
Last Update Posted:
2019-01-31
First Post:
2011-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Glucose and Insulin Responses to Snack Food Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Test ingredient production did not meet specification', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2011-04-22', 'studyFirstSubmitQcDate': '2011-04-22', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycaemic index of experimental test foods compared to that of control test food using venous plasma.', 'timeFrame': '0-120 minutes'}], 'secondaryOutcomes': [{'measure': 'Glycaemic index of experimental test foods compared to that of control test food using capillary blood', 'timeFrame': '0-120 minutes'}, {'measure': 'Determine and compare glycaemic responses to experimental test foods and control test food using venous plasma and capillary blood', 'timeFrame': '0-180 minutes'}, {'measure': 'Measure insulin in venous plasma', 'timeFrame': '0-180 minutes'}, {'measure': 'Measure C-peptide in venous plasma', 'timeFrame': '0-180 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Study Focus 1:Glycaemic Index', 'Study Focus 2:Glycaemic Response', 'Study Focus 3:Insulinemic Response']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of added food ingredients, when baked into a snack food product, on glycaemic index of the product and glycaemic and insulinemic responses to the product in healthy adults.'}, '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* Fasting blood glucose (finger-stick) \\>3.3 and \\<5.6 mmol/L (Visit 2)\n* Two-hour OGTT glucose (finger-stick) \\<7.8 mmol/L (Visit 2)\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Females who are lactating or may be pregnant or if of childbearing potential, are not taking adequate contraceptive precautions\n* Any significant concurrent illness\n* History of allergy likely to interfere with the study or known sensitivity to the test food or its ingredients\n* Have assessed an investigational product for GI in the last 72 hours.\n* Concurrent participation in any other safety study\n* History of diabetes, hepatitis, AIDS, anaemia or a heart condition\n* The use of any medication or dietary supplement which might, in the opinion of the principal investigator 1) make participation in the study dangerous to the subject, or 2) may affect the results.\n* Had any type of gastrointestinal surgery, including gastric bypass\n* Having consumed anything apart from plain water in the 12 hours prior to each test\n* Have been medically diagnosed as having high blood pressure or heart disease'}, 'identificationModule': {'nctId': 'NCT01341769', 'briefTitle': 'Blood Glucose and Insulin Responses to Snack Food Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mondelēz International, Inc.'}, 'officialTitle': 'A Study to Determine the Effects of Added Ingredients on Glycaemic and Insulinemic Responses to a Snack Food', 'orgStudyIdInfo': {'id': 'P10-08857 version 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Test Food', 'description': 'Snack base', 'interventionNames': ['Other: Dietary Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Test Food 1', 'description': 'Snack Base containing ingredient 1', 'interventionNames': ['Other: Dietary Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Test Food 2', 'description': 'Snack base containing ingredient 2', 'interventionNames': ['Other: Dietary Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Test Food 3', 'description': 'Snack base containing ingredients 1 and 2', 'interventionNames': ['Other: Dietary Intervention']}], 'interventions': [{'name': 'Dietary Intervention', 'type': 'OTHER', 'armGroupLabels': ['Control Test Food']}, {'name': 'Dietary Intervention', 'type': 'OTHER', 'armGroupLabels': ['Experimental Test Food 1']}, {'name': 'Dietary Intervention', 'type': 'OTHER', 'armGroupLabels': ['Experimental Test Food 2']}, {'name': 'Dietary Intervention', 'type': 'OTHER', 'armGroupLabels': ['Experimental Test Food 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG6 6BZ', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Reading Scientific Services Limited', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Valerie Hart, SCS, Dip, MICR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Reading Scientific Services Limited'}, {'name': 'Dr. Suzana Louth', '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': {'oldNameTitle': 'Richard Black, Ph.D., VP, Nutrition and Peter H. Brown, Ph.D., Research Principal, Nutrition Research', 'oldOrganization': 'Kraft Foods, Inc'}}}}