Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01275820
Status:
COMPLETED
Last Update Posted:
2011-01-12
First Post:
2011-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Glucose and Insulin Response to Nutralin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-11', 'studyFirstSubmitDate': '2011-01-10', 'studyFirstSubmitQcDate': '2011-01-11', 'lastUpdatePostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose blood level', 'timeFrame': '4 weeks', 'description': 'Measure the change in blood sugar levels'}], 'secondaryOutcomes': [{'measure': 'Dosage of Insulin', 'timeFrame': '4 weeks', 'description': 'Measure the levels of insulin'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes, insulin, blood sugar'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate how an investigational food product affects a healthy person's blood sugar and insulin levels.", 'detailedDescription': "The investigational food product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs using the product. The hypothesis for this study is that healthy human subjects will have an increase in insulin levels after consuming the investigational food product."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals in and around the area of Sioux Falls, SD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women who are at least 18 years of age\n* Non-diabetic\n\nExclusion Criteria:\n\n* Diabetes\n* Women who are pregnant, breastfeeding or planning to become pregnant\n* Current and active liver or kidney disease\n* Any food allergies\n* Celiac disease'}, 'identificationModule': {'nctId': 'NCT01275820', 'briefTitle': 'A Study to Evaluate Glucose and Insulin Response to Nutralin', 'organization': {'class': 'OTHER', 'fullName': 'Avera McKennan Hospital & University Health Center'}, 'officialTitle': 'A Study to Evaluate Glucose and Insulin Response to Nutralin', 'orgStudyIdInfo': {'id': 'ARI-1330-Nutralin'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nutralin', 'description': 'All 10 subjects in the study will consume the investigational food product.', 'interventionNames': ['Dietary Supplement: Nutralin']}], 'interventions': [{'name': 'Nutralin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['No other names at this time.'], 'description': 'Food product to be taken 15 minutes prior to each of the three main meals of the day.', 'armGroupLabels': ['Nutralin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Research Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'overallOfficials': [{'name': 'Edward Zawada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Avera McKennan Hospital & University Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avera McKennan Hospital & University Health Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vintek, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dave Kuper, RPh', 'oldOrganization': 'Avera Research Institute'}}}}