Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-25 @ 3:27 AM
Study NCT ID:
NCT00676767
Status:
COMPLETED
Last Update Posted:
2008-05-23
First Post:
2008-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistant Starch on Glycemic Response in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-22', 'studyFirstSubmitDate': '2008-05-08', 'studyFirstSubmitQcDate': '2008-05-12', 'lastUpdatePostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Response', 'timeFrame': '2-hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aging', 'Diabetes', 'Diet', 'Fiber'], 'conditions': ['Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine how blood glucose changes after eating energy bars containing resistant starch type 4 compared with bars made with puffed wheat in healthy older adults.', 'detailedDescription': 'To measure the blood glucose response, we collected blood samples before eating and 15, 30, 45, 60, 90 and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently healthy (not diagnosed with disease)\n* Over 60 years of age\n\nExclusion Criteria:\n\n* Diagnosed with diabetes or other metabolic disorder\n* Allergies to wheat\n* Non-smokers'}, 'identificationModule': {'nctId': 'NCT00676767', 'briefTitle': 'Resistant Starch on Glycemic Response in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Kansas State University'}, 'officialTitle': 'Resistant Starch Type 4 on the Glycemic Response in Older Adults', 'orgStudyIdInfo': {'id': 'KSU-HML-RSt1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Dietary Supplement: Resistant Starch Type 4']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Dietary Supplement: Dextrose']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Dietary Supplement: Puffed wheat']}], 'interventions': [{'name': 'Resistant Starch Type 4', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['1']}, {'name': 'Dextrose', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['2']}, {'name': 'Puffed wheat', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66506', 'city': 'Manhattan', 'state': 'Kansas', 'country': 'United States', 'facility': 'Human Metabolism Laboratory', 'geoPoint': {'lat': 39.18361, 'lon': -96.57167}}], 'overallOfficials': [{'name': 'Mark D Haub, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kansas State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MGP Ingredients, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mark D. Haub, Ph.D., Associate Professor', 'oldOrganization': 'Kansas State University'}}}}