Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-03-12 @ 8:00 AM
Study NCT ID:
NCT02720393
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2016-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-26', 'studyFirstSubmitDate': '2016-02-09', 'studyFirstSubmitQcDate': '2016-03-21', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in fecal microbiome', 'timeFrame': 'baseline, 12 weeks', 'description': 'Impact of diet on fecal microbiome following dietary intervention determined by whole genome sequencing of fecal bacteria'}, {'measure': 'Change in fecal calprotectin', 'timeFrame': 'baseline, 12 weeks', 'description': 'determine effect of dietary intervention on fecal calprotectin'}], 'primaryOutcomes': [{'measure': 'Change in hemoglobin A1c', 'timeFrame': 'baseline, 12 weeks', 'description': 'Measurements performed after 12 weeks of dietary intervention'}], 'secondaryOutcomes': [{'measure': 'Change in serum Interleukin-8', 'timeFrame': 'baseline, 12 weeks', 'description': 'Impact of diet on serum Interleukin-8'}, {'measure': 'Impact on glucose tolerance test', 'timeFrame': '12 weeks', 'description': 'perform repeat oral glucose tolerance test after 12 weeks of dietary intervention'}, {'measure': 'Impact on insulin level', 'timeFrame': '12 weeks', 'description': 'determine effect of dietary intervention on insulin level at the time of glucose tolerance test'}, {'measure': 'Change in leukocyte subsets', 'timeFrame': 'baseline, 12 weeks', 'description': 'determine if there is change in distribution of leukocyte subsets from blood samples of study participants'}, {'measure': 'Change in Tumor Necrosis Factor-alpha in serum', 'timeFrame': 'baseline, 12 weeks', 'description': 'determine if there is change in circulating TNF-alpha in blood samples'}, {'measure': 'Change in insulin signaling pathway', 'timeFrame': 'baseline, 12 weeks', 'description': 'determine if there are changes in activation of intermediates in insulin signaling pathway in circulating leukocytes following dietary intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prediabetes']}, 'descriptionModule': {'briefSummary': 'Participants will be randomly assigned to either regular or no-carrageenan prepared diets to determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin A1c is the primary outcome measure.', 'detailedDescription': 'Subjects will be randomly assigned to a diet. They will at onset have hemoglobin A1c values between 5.7% and 6.4%. Baseline glucose tolerance test will be performed, as well as measures of inflammation and fecal microbiome. Interim tests will be performed at six weeks. Subjects will participate for 12 weeks, at which time they will be re-evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* per diabetes, ability to follow diet and study procedures\n\nExclusion Criteria:\n\n* on any medications that affect glucose, medical conditions or allergies that affect adherence to study diet, pregnancy'}, 'identificationModule': {'nctId': 'NCT02720393', 'briefTitle': 'Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Impact of no Carrageenan Diet on Glucose Tolerance in Prediabetes', 'orgStudyIdInfo': {'id': '2015-1255'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Regular diet', 'description': 'Meals and snacks will contain carrageenan in the amount consumed in the typical daily diet and will be selected by the study dietician and distributed to study subjects randomized to the regular diet study arm.', 'interventionNames': ['Other: Regular Diet']}, {'type': 'EXPERIMENTAL', 'label': 'No-carrageenan diet', 'description': 'No-carrageenan diet will be composed of meals and snacks selected by the study dietician and distributed to study participants who are randomized to the no-carrageenan diet study arm.', 'interventionNames': ['Other: No-carrageenan diet']}], 'interventions': [{'name': 'No-carrageenan diet', 'type': 'OTHER', 'description': 'Diet of food items that have no carrageenan as selected by study dietician.', 'armGroupLabels': ['No-carrageenan diet']}, {'name': 'Regular Diet', 'type': 'OTHER', 'otherNames': ['Carrageenan-containing diet'], 'description': 'Diet of food items that have carrageenan as selected by study dietician', 'armGroupLabels': ['Regular diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If required, individual data without identifiers may be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Joanne Kramer Tobacman', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}