Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 2:55 AM
Study NCT ID:
NCT01058135
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Hi-maize Resistant Starch on Insulin Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2010-01-26', 'studyFirstSubmitQcDate': '2010-01-27', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin sensitivity', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Inflammatory markers, glycemia, serum lipids', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin resistance', 'dietary fiber', 'resistant starch'], 'conditions': ['Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '22357745', 'type': 'DERIVED', 'citation': 'Maki KC, Pelkman CL, Finocchiaro ET, Kelley KM, Lawless AL, Schild AL, Rains TM. Resistant starch from high-amylose maize increases insulin sensitivity in overweight and obese men. J Nutr. 2012 Apr;142(4):717-23. doi: 10.3945/jn.111.152975. Epub 2012 Feb 22.'}], 'seeAlsoLinks': [{'url': 'http://www.resistantstarch.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of a dietary fiber, resistant starch, on insulin sensitivity. Low insulin sensitivity is a risk factor for some diseases including type 2 diabetes and heart disease. This study will show if consuming resistant starch can help improve insulin sensitivity in overweight and obese people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable body weight\n* No serious health conditions\n* Waist circumference \\> or = to 89 cm (females) and 102 cm (males)\n\nExclusion Criteria:\n\n* Diabetes\n* other serious illnesses\n* use of medications that affect outcomes\n* BMI \\> or = 35.0 kg/m2'}, 'identificationModule': {'nctId': 'NCT01058135', 'briefTitle': 'Effects of Hi-maize Resistant Starch on Insulin Sensitivity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ingredion Incorporated'}, 'officialTitle': 'A Randomized, Controlled, Double-blind Crossover Study to Assess the Effects of a Dietary Fiber Ingredient, at Two Doses, on Insulin Sensitivity', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hi-maize starch (Low dose)', 'type': 'OTHER', 'description': 'resistant starch'}, {'name': 'Hi-maize starch (High-dose)', 'type': 'OTHER', 'description': 'resistant starch'}, {'name': 'Control (starch)', 'type': 'OTHER', 'description': 'rapidly digestible starch'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60137', 'city': 'Glen Ellyn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Provident Clinical Research and Consulting, Inc', 'geoPoint': {'lat': 41.87753, 'lon': -88.06701}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ingredion Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}