Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02161250
Status:
COMPLETED
Last Update Posted:
2014-06-12
First Post:
2014-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-10-08', 'releaseDate': '2015-09-08'}, {'releaseDate': '2015-10-16', 'unreleaseDateUnknown': True}, {'resetDate': '2015-11-18', 'releaseDate': '2015-10-19'}, {'resetDate': '2016-02-01', 'releaseDate': '2015-12-30'}, {'resetDate': '2016-03-08', 'releaseDate': '2016-02-10'}, {'resetDate': '2016-10-26', 'releaseDate': '2016-09-08'}, {'resetDate': '2018-11-02', 'releaseDate': '2018-04-05'}, {'resetDate': '2019-06-18', 'releaseDate': '2019-03-19'}, {'resetDate': '2020-07-31', 'releaseDate': '2020-07-16'}], 'estimatedResultsFirstSubmitDate': '2015-09-08'}}, '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'}], '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-11', 'studyFirstSubmitDate': '2014-06-09', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'resistant starch effects', 'timeFrame': '2 weeks', 'description': 'effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperglycemia, Diabetes, and Obesity']}, 'descriptionModule': {'briefSummary': 'Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily digested carbohydrate).', 'detailedDescription': '* About two-thirds of adults in the United States are overweight or obese which can cause adverse health consequences for those individuals. Post-prandial hyperglycemia is one of these possible consequences and is associated with a higher risk for Type 2 Diabetes. Controlling hyperglycemia is important in the prevention of the onset of diabetes and obesity. Resistant starch is a dietary carbohydrate which is not completely digested in the gut and produces energy for the body to use. The investigators are interested in assessing the effects of resistant starch on postprandial blood glucose and insulin concentrations.\n* Aim: To assess the effects of a resistant starch on post-prandial blood glucose and insulin concentrations.\n* Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to a beverage with maltodextrin (an easily digested carbohydrate).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thirty healthy men and women (aged 18-29y) will be recruited from the greater Lafayette, IN region with the expectation that ≥20 subjects will complete the study. Subjects must weigh \\>110 pounds, with a BMI between 20.0 and 29.9.\n\nExclusion Criteria:\n\n* Weight change \\> 3kg in the past 3 months\n* Exercising vigorously over the past 3 months as well as no exercise 3 days prior to testing day\n* Intestinal disorders including lipid mal-absorption or lactose intolerance\n* Abnormal liver or kidney function tests; fasting blood glucose \\>100mg/dL\n* Smoking\n* Drinking more than 2 alcoholic drinks per day\n* Taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.\n* Subjects must not be pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT02161250', 'briefTitle': 'Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses', 'orgStudyIdInfo': {'id': '1312014354'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistant starch', 'description': 'The test beverage consumed has the resistant starch.', 'interventionNames': ['Dietary Supplement: Resistant Starch']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'The control beverage uses maltodextrin rather than the resistant starch.', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'Resistant Starch', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing resistant starch. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.', 'armGroupLabels': ['Resistant starch']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing maltodextrin. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47905', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Wayne Campbell, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ingredion Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wayne Campbell', 'investigatorAffiliation': 'Purdue University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-09-08', 'type': 'RELEASE'}, {'date': '2015-10-08', 'type': 'RESET'}, {'date': '2015-10-16', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2015-10-19', 'type': 'RELEASE'}, {'date': '2015-11-18', 'type': 'RESET'}, {'date': '2015-12-30', 'type': 'RELEASE'}, {'date': '2016-02-01', 'type': 'RESET'}, {'date': '2016-02-10', 'type': 'RELEASE'}, {'date': '2016-03-08', 'type': 'RESET'}, {'date': '2016-09-08', 'type': 'RELEASE'}, {'date': '2016-10-26', 'type': 'RESET'}, {'date': '2018-04-05', 'type': 'RELEASE'}, {'date': '2018-11-02', 'type': 'RESET'}, {'date': '2019-03-19', 'type': 'RELEASE'}, {'date': '2019-06-18', 'type': 'RESET'}, {'date': '2020-07-16', 'type': 'RELEASE'}, {'date': '2020-07-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Wayne Campbell, Professor, Purdue University'}}}}