Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-07 @ 11:58 PM
Study NCT ID:
NCT03741660
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2018-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C022901', 'term': '(1-6)-alpha-glucomannan'}, {'id': 'D004043', 'term': 'Dietary Fiber'}], 'ancestors': [{'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '1998-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '1992-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in total:HDL cholesterol', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'change in fructosamine', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'change in systolic blood pressure', 'timeFrame': 'change from baseline at week 3, relative to control'}], 'secondaryOutcomes': [{'measure': 'change in total cholesterol', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'change in LDL cholesterol', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'change in HDL cholesterol', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'change in apolipoprotein A-1', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'change in apolipoprotain B', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'change in glucose', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'change in insulin', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'diastolic blood pressure', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'change in body weight', 'timeFrame': 'change from baseline at week 3, relative to control'}, {'measure': 'change in apoB:ApoA-1', 'timeFrame': 'change from baseline at week 3, relative to control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['konjac', 'type2 diabetes', 'fiber', 'coronary heart disease'], 'conditions': ['Type2 Diabetes', 'Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'To examine whether Konjac-mannan fiber improves metabolic control measured by glycemia, lipidemia, and blood pressure in individuals with type-2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hyperlipidemia controlled by medication\n* hypertension controlled by medication\n* type 2 diabetes controlled by medication\n* minimum 3 years since onset of all three conditions\n* sedentary lifestyle\n\nExclusion Criteria:\n\n* regular smoking\n* regular alcohol consumption\n* family history of premature coronary heart disease\n* hypothyroidism\n* renal, hepatic or gastrointestinal disease'}, 'identificationModule': {'nctId': 'NCT03741660', 'briefTitle': 'Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Konjac-Mannan (Glucomannan) Improves Glycemia and Other Associated Risk Factors for Coronary Heart Disease in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'Konjac in T2DM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Konjac-mannan', 'description': 'Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet', 'interventionNames': ['Dietary Supplement: konjac glucomannan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'wheat bran fiber biscuits with NCEP Step II metabolically controlled diet', 'interventionNames': ['Dietary Supplement: wheat bran']}], 'interventions': [{'name': 'konjac glucomannan', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Konjac-mannan fiber-enriched biscuits (0.7 g/412KJ \\[100kcal\\] of glucommanan)', 'armGroupLabels': ['Konjac-mannan']}, {'name': 'wheat bran', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Wheat bran (hard red wheat bran) fiber enriched biscuits', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dicofarm', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}