Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-04-24 @ 12:43 AM
Study NCT ID:
NCT03224806
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2017-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Fiber Composite-enriched Breads on Glycemic Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2017-07-19', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose AUC', 'timeFrame': '2 hours', 'description': 'Incremental area under the glucose response curve ignoring area below fasting glucose'}], 'secondaryOutcomes': [{'measure': 'Satiety AUC', 'timeFrame': '2 hours', 'description': 'Incremental area under the satiety response curve'}, {'measure': 'Hydrolysis index', 'timeFrame': '2 hours', 'description': 'Incremental area under the hydrolysis curve (amount of glucose released during in-vitro digestion of the breads) expressed as a percentage of that for white bread.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glycemic Response']}, 'descriptionModule': {'briefSummary': 'Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at intervals over 2 hours. They also rated their feelings of satiety fasting and at intervals over 2 hours.', 'detailedDescription': 'Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples 5 minutes apart, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at 15, 30, 45, 60,90 and 120 min after starting to eat. After each blood sample also rated their feelings of satiety on a 7-point scale from extremely hungry to extremely full.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good health\n\nExclusion Criteria:\n\n* Known history of AIDS, hepatitis, diabetes or a heart condition\n* Use of drugs which would increase risk to the subject or affect the results in the opinion of the medical director\n* Any condition which would increase risk to the subject or affect the results in the opinion of the medical director\n* Individuals who cannot or will not comply with experimental procedures or do not follow safety guidelines.'}, 'identificationModule': {'nctId': 'NCT03224806', 'briefTitle': 'Effect of Fiber Composite-enriched Breads on Glycemic Responses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glycemic Index Laboratories, Inc'}, 'officialTitle': 'Effect of Fiber Composite-enriched Breads on Glycemic Responses', 'orgStudyIdInfo': {'id': 'GIL-1426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Wholegrain bread', 'interventionNames': ['Other: Wholegrain bread']}, {'type': 'OTHER', 'label': 'White bread', 'interventionNames': ['Other: White bread']}, {'type': 'OTHER', 'label': '15% fiber-rich bread', 'interventionNames': ['Other: 15% fiber-rich bread']}, {'type': 'OTHER', 'label': '30% fiber-rich bread', 'interventionNames': ['Other: 30% fiber-rich bread']}], 'interventions': [{'name': 'Wholegrain bread', 'type': 'OTHER', 'description': '156.8g wholegrain bread', 'armGroupLabels': ['Wholegrain bread']}, {'name': 'White bread', 'type': 'OTHER', 'description': '122.6g white bread', 'armGroupLabels': ['White bread']}, {'name': '15% fiber-rich bread', 'type': 'OTHER', 'description': '139.2g bread made with 15% added wheat bran', 'armGroupLabels': ['15% fiber-rich bread']}, {'name': '30% fiber-rich bread', 'type': 'OTHER', 'description': '166.5g bread made with 30% added wheat bran', 'armGroupLabels': ['30% fiber-rich bread']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5C 2X3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Glycemic Index Laboratories, Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Thomas MS Wolever, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GI Labs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glycemic Index Laboratories, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Guelph', 'class': 'OTHER'}, {'name': 'Guelph Research and Development Centre, Agriculture and Agri-Food Canada', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}