Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT00930956
Status:
COMPLETED
Last Update Posted:
2010-07-29
First Post:
2009-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Different Types of Resistant Starch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000084922', 'term': 'Resistant Starch'}, {'id': 'C572111', 'term': 'high-amylose maize type 2 resistant starch, maize'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-28', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-06-30', 'lastUpdatePostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': 'Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Obesity', 'Hyperglycemia', 'Dietary Fiber', 'Wheat', 'Grain'], 'conditions': ['Postprandial Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'This study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.', 'detailedDescription': 'Each volunteer will visit the laboratory in a 10-12 hour fasted state on three occasions over a three-week period, up to two visits/wk, with at least 48 hours between visits. Volunteers will be asked to refrain from vigorous physical activity and the consumption of alcohol the day before each testing visit. Randomization using a Latin Square design was applied to minimize confounding issues associated with the order of administration.\n\nIn the morning of each test, a finger-prick capillary blood samples will be collected to determine fasting (baseline) blood glucose levels. The volunteers will then consume the test solution assigned for that trial. Ten minutes will be allowed for the test solution to be consumed. Over the two hours following the start of each test, finger-prick capillary blood samples were collected at 30, 60, 90, and 120 min. Blood glucose levels will be immediately measured in duplicate using an automated blood glucose analyzer (YSI 2300, Yellow Springs, OH). Analysis of the collected sample was repeated if the difference between duplicate samples was greater than 0.1 mmol/L. Once the samples were analyzed, the data was entered and the incremental area under the curve was calculated using the trapezoidal model (GraphPad v5.0, La Jolla, CA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* apparently healthy\n\nExclusion Criteria:\n\n* diagnosis of any chronic disease\n* wheat allergy'}, 'identificationModule': {'nctId': 'NCT00930956', 'briefTitle': 'Comparison of Different Types of Resistant Starch', 'organization': {'class': 'OTHER', 'fullName': 'Kansas State University'}, 'officialTitle': 'Resistant Starch Type 2 and Cross Linked Resistant Starch Type 4 on Blood Glucose', 'orgStudyIdInfo': {'id': 'KSUHML09-RS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dextrose', 'description': '30 g of carbohydrate via Sun-Dex OGTT beverage', 'interventionNames': ['Dietary Supplement: Resistant Starch']}, {'type': 'EXPERIMENTAL', 'label': 'RS Type 2', 'description': '30g Resistant Starch Type 2 (Hi-Maize 260, National Starch)', 'interventionNames': ['Dietary Supplement: Resistant Starch']}, {'type': 'EXPERIMENTAL', 'label': 'RS Type 4 (cross linked)', 'description': '30g of cross linked RS type 4 (Fibersym RW, MGP Ingredients, Inc.)', 'interventionNames': ['Dietary Supplement: Resistant Starch']}], 'interventions': [{'name': 'Resistant Starch', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Hi-Maize 260', 'Fibersym RW'], 'description': '30 g of carbohydrate per Arm', 'armGroupLabels': ['Dextrose', 'RS Type 2', 'RS Type 4 (cross linked)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66502', 'city': 'Manhattan', 'state': 'Kansas', 'country': 'United States', 'facility': 'Human Metabolism Laboratory (K-State Univ.)', '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'}, 'responsibleParty': {'oldNameTitle': 'Mark Haub', 'oldOrganization': 'Kansas State University'}}}}