Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT00687960
Status:
COMPLETED
Last Update Posted:
2008-06-02
First Post:
2008-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young 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': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-28', 'studyFirstSubmitDate': '2008-05-22', 'studyFirstSubmitQcDate': '2008-05-28', 'lastUpdatePostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Prandial Metabolism', 'timeFrame': 'Early morning'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Diet', 'Fiber', 'Age'], 'conditions': ['Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'This study tested the effects of resistant starch type 4 on blood sugar and hunger in young adults with Type 2 diabetes.', 'detailedDescription': 'To measure the blood glucose response, after an overnight fast, blood samples were collected before eating and at 15, 30, 45, 60, 90, and 120 minutes after each each bar. The incremental area under the curve was used to calculate the glycemic index and insulin sensitivity via minimal model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently Healthy (not diagnosed with disease)\n* Young Adults (18-35)\n\nExclusion Criteria:\n\n* Diagnosed with diabetes or other metabolic disorders\n* Allergies to Wheat\n* Non-smokers'}, 'identificationModule': {'nctId': 'NCT00687960', 'briefTitle': 'Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Kansas State University'}, 'officialTitle': 'Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults', 'orgStudyIdInfo': {'id': 'KSU-HML-RSt2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Resistant Starch Type 4-Raw', 'interventionNames': ['Dietary Supplement: Resistant starch type 4 - raw']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Resistant Starch Type 4-cooked', 'interventionNames': ['Dietary Supplement: Resistant Starch Type 4 - Cooked']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Puffed wheat', 'interventionNames': ['Dietary Supplement: Puffed Wheat']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Dextrose', 'interventionNames': ['Dietary Supplement: Dextrose']}], 'interventions': [{'name': 'Resistant starch type 4 - raw', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose: 80g bar containing Resistant Starch Type 4 - raw', 'armGroupLabels': ['1']}, {'name': 'Resistant Starch Type 4 - Cooked', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose: 80g bar containing Resistant Starch Type 4 - cooked', 'armGroupLabels': ['2']}, {'name': 'Dextrose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose: 7 oz of oral glucose tolerance beverage', 'armGroupLabels': ['4']}, {'name': 'Puffed Wheat', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose: 80g bar containing puffed wheat cereal', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66506', 'city': 'Manhattan', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas State University', 'geoPoint': {'lat': 39.18361, 'lon': -96.57167}}], 'overallOfficials': [{'name': 'Mark Haub, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Human Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kansas State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MGP Ingredients, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mark Haub Ph.D.', 'oldOrganization': 'Department of Human Nutrition'}}}}