Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-02-28 @ 6:32 PM
Study NCT ID:
NCT03293706
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Carbohydrates Part 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-14', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breath hydrogen', 'timeFrame': '0 to 7 hours', 'description': 'Assessed in exhaled gasses'}], 'secondaryOutcomes': [{'measure': 'GI tolerance symptoms', 'timeFrame': '0 to 48 hours', 'description': 'Assessed using a subject tolerance questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastro-Intestinal Tolerance']}, 'descriptionModule': {'briefSummary': 'The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal tolerance of carbohydrate blends.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or non-pregnant females in good health.\n* Eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.\n\nExclusion Criteria:\n\n* Subject with any type of food allergy or with a known history of AIDS, hepatitis, diabetes, cardio-vascular disease or GI disease.\n* Subject taking medication, or with any condition which might, in the opinion of the PI either make participation dangerous to the subject or to others or affect the results.'}, 'identificationModule': {'nctId': 'NCT03293706', 'briefTitle': 'Evaluation of Carbohydrates Part 2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Evaluation of Carbohydrates (CHO): Tolerance, Breath Hydrogen and Methane', 'orgStudyIdInfo': {'id': 'BL37 Part 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CHO Control 1 Glucose', 'description': '25 g glucose', 'interventionNames': ['Other: CHO Control 1 and 2 Glucose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHO Control 2 Glucose', 'description': '25 g glucose', 'interventionNames': ['Other: CHO Control 1 and 2 Glucose']}, {'type': 'EXPERIMENTAL', 'label': 'CHO Experimental 1 Slowly Digested', 'description': '25 g slowly-digested carbohydrate blend', 'interventionNames': ['Other: CHO Experimental 1 Slowly Digested']}, {'type': 'EXPERIMENTAL', 'label': 'CHO Experimental 2 Digestion Resistant', 'description': '25 g digestion-resistant carbohydrate blend', 'interventionNames': ['Other: CHO Experimental 2 Digestion Resistant']}, {'type': 'EXPERIMENTAL', 'label': 'CHO Experimental 3 Low Sugar', 'description': '25 g low sugar carbohydrate blend', 'interventionNames': ['Other: CHO Experimental 3 Low Sugar']}, {'type': 'EXPERIMENTAL', 'label': 'CHO Experimental 4 Maltodextrin', 'description': '25 g maltodextrin', 'interventionNames': ['Other: CHO Experimental 4 Maltodextrin']}], 'interventions': [{'name': 'CHO Control 1 and 2 Glucose', 'type': 'OTHER', 'description': 'mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption', 'armGroupLabels': ['CHO Control 1 Glucose', 'CHO Control 2 Glucose']}, {'name': 'CHO Experimental 1 Slowly Digested', 'type': 'OTHER', 'description': 'mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption', 'armGroupLabels': ['CHO Experimental 1 Slowly Digested']}, {'name': 'CHO Experimental 2 Digestion Resistant', 'type': 'OTHER', 'description': 'mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption', 'armGroupLabels': ['CHO Experimental 2 Digestion Resistant']}, {'name': 'CHO Experimental 3 Low Sugar', 'type': 'OTHER', 'description': 'mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption', 'armGroupLabels': ['CHO Experimental 3 Low Sugar']}, {'name': 'CHO Experimental 4 Maltodextrin', 'type': 'OTHER', 'description': 'mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption', 'armGroupLabels': ['CHO Experimental 4 Maltodextrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5C 2N8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Glycemic Index Laboratories, Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Vikkie Mustad, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}