Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT02814357
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2016-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Test the Effect of Selected Fibres and Flours in Flat Bread on Post-Prandial Blood Glucose and Insulin Responses in Healthy Indian Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005433', 'term': 'Flour'}, {'id': 'C007894', 'term': 'guar gum'}], 'ancestors': [{'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', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cmax glucose', 'timeFrame': '0-120 minutes'}, {'measure': 'Tmax glucose', 'timeFrame': '0-120 minutes'}, {'measure': 'Slope to Cmax', 'timeFrame': '0-120 minutes'}, {'measure': 'Glucose concentration', 'timeFrame': '180 minutes'}, {'measure': 'Insulin concentration', 'timeFrame': '180 minutes'}, {'measure': 'Total area under the glucose curve', 'timeFrame': '0-180 minutes'}, {'measure': 'Total area under the curve of appetite and mood', 'timeFrame': '0-120 minutes'}], 'primaryOutcomes': [{'measure': 'Positive incremental area under blood glucose curve', 'timeFrame': '0-120 minutes'}], 'secondaryOutcomes': [{'measure': 'Total area under the serum insulin curve', 'timeFrame': '0-120 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Blood glucose, serum insulin'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Double-blind, randomized, controlled, cross-over design with 3 test products and one control product.\n\nTo evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour 15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG) and serum insulin levels in healthy Indian subjects, after the consumption of flat bread made from 100 gram of flour compositions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects between \\> 20 and \\< 50 years of age\n* BMI of \\>18 and \\< 23 kg/m2\n* Fasting blood glucose value of volunteer is \\> 3.4 and \\<6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening\n\nExclusion Criteria:\n\n* Chronic smokers, tobacco chewers and drinkers.'}, 'identificationModule': {'nctId': 'NCT02814357', 'briefTitle': 'To Test the Effect of Selected Fibres and Flours in Flat Bread on Post-Prandial Blood Glucose and Insulin Responses in Healthy Indian Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever R&D'}, 'officialTitle': 'To Evaluate the Effect of 4 Different Flour Compositions of Selected Fibres and Flours, on Post-prandial Plasma Glucose (PPG) and Serum Insulin Levels in Normal Indian Healthy Subjects', 'orgStudyIdInfo': {'id': 'FDS-NAA-0224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control (market standard)', 'description': '100 g wheat flour (atta)', 'interventionNames': ['Other: Control (market standard)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High fibre 1', 'description': '81% wheat flour (atta) + 15% chickpea + 4% guar gum', 'interventionNames': ['Other: wheat flour', 'Other: chickpea flour', 'Other: guar gum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High fibre 2', 'description': '80% wheat flour (atta) + 15% chickpea + 2% guar gum + 3% barley', 'interventionNames': ['Other: wheat flour', 'Other: chickpea flour', 'Other: guar gum', 'Other: barley']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High fibre 3', 'description': '77% wheat flour (atta) + 15% chickpea + 3% guar gum + 5% barley', 'interventionNames': ['Other: wheat flour', 'Other: chickpea flour', 'Other: guar gum', 'Other: barley']}], 'interventions': [{'name': 'Control (market standard)', 'type': 'OTHER', 'armGroupLabels': ['Control (market standard)']}, {'name': 'wheat flour', 'type': 'OTHER', 'armGroupLabels': ['High fibre 1', 'High fibre 2', 'High fibre 3']}, {'name': 'chickpea flour', 'type': 'OTHER', 'armGroupLabels': ['High fibre 1', 'High fibre 2', 'High fibre 3']}, {'name': 'guar gum', 'type': 'OTHER', 'armGroupLabels': ['High fibre 1', 'High fibre 2', 'High fibre 3']}, {'name': 'barley', 'type': 'OTHER', 'armGroupLabels': ['High fibre 2', 'High fibre 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '380 061 Gujrat', 'city': 'Ahmedabad', 'state': 'Near Gujrat High Court, SG Highway, Gota', 'country': 'India', 'facility': 'Lambda Therapeutics Research Ltd (LTRL)', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}], 'overallOfficials': [{'name': 'Rakesh Patel, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lambda Therapeutic Research Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}