Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-20 @ 4:31 PM
Study NCT ID:
NCT02256332
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2014-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2014-09-30', 'studyFirstSubmitQcDate': '2014-10-02', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Post prandial blood glucose positive incremental area under the curve', 'timeFrame': '180 and 240 minutes'}, {'measure': 'Post prandial insulin area under the curve', 'timeFrame': '180 and 240 minutes'}, {'measure': 'Glucose levels in urine', 'timeFrame': '240 minutes'}, {'measure': 'Intestinal discomfort', 'timeFrame': '240 minutes', 'description': "Intestinal discomfort will be evaluated by a paper and pen questionnaire in the subject's native language directed to intestinal symptoms (nausea, flatulence, bloating and abdominal pain)."}], 'primaryOutcomes': [{'measure': 'Post prandial blood glucose positive incremental area under the curve', 'timeFrame': '120 minutes'}], 'secondaryOutcomes': [{'measure': 'Post prandial insulin area under the curve', 'timeFrame': '120 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Effects of a plant based ingredient on blood glucose in Type II diabetes patients.', 'detailedDescription': 'The study is designed to determine the extend to which a plant based ingredient in a food format affects blood glucose responses in untreated Type II diabetes patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female volunteers with confirmed Type II diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);\n* Age ≥ 20 and ≤ 65 year at screening;\n* Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;\n* HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). At discretion of the study physician, subjects with HbA1c \\>53 mmol/mol and \\<58 mmol/mol (\\>7.0% and \\< 7.5%) controlled solely through diet and exercise are also allowed to participate.\n\nExclusion Criteria:\n\n* Being an employee of Unilever or research site;\n* Chronic smokers, tobacco chewers and drinkers;\n* No medication, including vitamins and tonics, except for cholesterol, as determined by the physician;\n* Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;\n* Allergy to any food or cosmetics;\n* If female, not being pregnant or planning pregnancy during the study period;\n* If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.'}, 'identificationModule': {'nctId': 'NCT02256332', 'briefTitle': 'Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever R&D'}, 'officialTitle': 'Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients', 'orgStudyIdInfo': {'id': 'FDS-NAA-1633'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose plant based ingredient', 'description': 'Reference food with low dose of plant based ingredient', 'interventionNames': ['Dietary Supplement: Low dose plant based ingredient']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose plant based ingredient', 'description': 'Reference food with high dose of plant based ingredient', 'interventionNames': ['Dietary Supplement: High dose plant based ingredient']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Reference food format', 'description': 'Reference food without plant-based ingredient', 'interventionNames': ['Dietary Supplement: Reference food format']}], 'interventions': [{'name': 'Low dose plant based ingredient', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Reference food with low dose of plant based ingredient', 'armGroupLabels': ['Low dose plant based ingredient']}, {'name': 'High dose plant based ingredient', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Reference food with high dose of plant based ingredient', 'armGroupLabels': ['High dose plant based ingredient']}, {'name': 'Reference food format', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Reference food without plant-based ingredient', 'armGroupLabels': ['Reference food format']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Thane', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA', 'geoPoint': {'lat': 19.19704, 'lon': 72.96355}}, {'city': 'Ahemdabad', 'country': 'India', 'facility': 'Lambda Therapeutics Research Ttd (LTRL)'}], 'overallOfficials': [{'name': 'Dr Ketul Modi, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lambda Therapeutics Research Ltd (LTRL)'}, {'name': 'Dr Shrikant V Deshpande', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}