Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 11:51 AM
Study NCT ID:
NCT00935350
Status:
COMPLETED
Last Update Posted:
2009-07-09
First Post:
2009-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of the Glycemic Index by a Novel Viscous Polysaccharide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C540519', 'term': 'PolyGlycoplex'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-08', 'studyFirstSubmitDate': '2009-03-25', 'studyFirstSubmitQcDate': '2009-07-08', 'lastUpdatePostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Blood glucose response of food with and without NVP', 'timeFrame': 'Acute blood glucose response measured at 0, 15,30,45,60,90 and 120 min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['viscous', 'fibre', 'polysaccharide', 'blood glucose', 'postprandial'], 'conditions': ['Blood Glucose, Postprandial']}, 'referencesModule': {'references': [{'pmid': '21092221', 'type': 'DERIVED', 'citation': 'Jenkins AL, Kacinik V, Lyon M, Wolever TM. Effect of adding the novel fiber, PGX(R), to commonly consumed foods on glycemic response, glycemic index and GRIP: a simple and effective strategy for reducing post prandial blood glucose levels--a randomized, controlled trial. Nutr J. 2010 Nov 22;9:58. doi: 10.1186/1475-2891-9-58.'}]}, 'descriptionModule': {'briefSummary': 'Reductions of postprandial glucose levels have been demonstrated previously with the addition of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods.', 'detailedDescription': 'Recently, a commercial novel viscous polysaccharide (NVP)complex has been developed which is marketed in both the USA and Canada under the trade name PGX® (PolyGlycopleX) (InovoBiologic Inc, Calgary, AB, Canada). This complex consists of three viscous non starch polysaccharides which are processed using proprietary technology (EnviroSimplex®) to produce compressed granules which delays the onset of viscosity and increases palatability of the fiber when added to food. Previously, this fibre was shown to lower postprandial glucose levels in a dose responsive manner when mixed with a glucose drink and sprinkled onto a standard white bread demonstrating that the processing did not interfere with the effectiveness of the fiber. From this study the reduction in GI was calculated to be 7 units per gram of NVP when added to a solid food, however it is not known whether this relationship would be maintained when the NVP was added to a range of commonly eaten foods. This study therefore evaluates the effect of the addition or incorporation of NVP into a range of foods on postprandial glycemia and whether the reductions in glycemic index could be predicted using.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy individuals\n* 18-75 years old\n* BMI less than 35 kg/m2\n\nExclusion Criteria:\n\n* Medications influencing gastrointestinal function\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00935350', 'briefTitle': 'Reduction of the Glycemic Index by a Novel Viscous Polysaccharide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glycemic Index Laboratories, Inc'}, 'officialTitle': 'Effect of Adding the Novel Fiber, PGX®,to Commonly Consumed Foods on Glycemic Response and Glycemic Index: A Practical and Effective Strategy for Reducing Post Prandial Blood Glucose Levels.', 'orgStudyIdInfo': {'id': 'GIL-6033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Control White bread containing 50g available carbohydrate', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'White bread and milk control', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Granola control', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Cornflakes and milk control', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5', 'description': 'White rice control', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '6', 'description': 'Fruit yogurt control', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '7', 'description': 'Turkey dinner control', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'EXPERIMENTAL', 'label': '8', 'description': 'Granola', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'EXPERIMENTAL', 'label': '9', 'description': 'Cornflakes and milk', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'EXPERIMENTAL', 'label': '10', 'description': 'White Rice', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'EXPERIMENTAL', 'label': '11', 'description': 'Fruit yogurt', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'EXPERIMENTAL', 'label': '12', 'description': 'Turkey dinner', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '13', 'description': 'White Bread', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '14', 'description': 'White bread', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}, {'type': 'EXPERIMENTAL', 'label': '15', 'description': 'Granola', 'interventionNames': ['Dietary Supplement: PolyGlycopleX (PGX)']}], 'interventions': [{'name': 'PolyGlycopleX (PGX)', 'type': 'DIETARY_SUPPLEMENT', 'description': '2.5 grams of PGX', 'armGroupLabels': ['15', '8']}, {'name': 'PolyGlycopleX (PGX)', 'type': 'DIETARY_SUPPLEMENT', 'description': '5.0 grams of PGX', 'armGroupLabels': ['10', '11', '12', '8', '9']}, {'name': 'PolyGlycopleX (PGX)', 'type': 'DIETARY_SUPPLEMENT', 'description': '0 grams of PGX', 'armGroupLabels': ['1', '13', '14', '2', '3', '4', '5', '6', '7']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Glycemic Index Laboratories, Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Alexandra L Jenkins, PhD, RD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glycemic Index Laboratories, Inc'}, {'name': 'Thomas MS Wolever, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glycemic Index Laboratories, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glycemic Index Laboratories, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'InovoBiologic Inc.', 'class': 'INDUSTRY'}, {'name': 'Canadian Center for Functional Medicine', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Alexandra Jenkins, PhD, RD/ Vice President', 'oldOrganization': 'Glycemic Index Laboratories, Inc.'}}}}