Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-26 @ 3:56 PM
Study NCT ID:
NCT00877968
Status:
COMPLETED
Last Update Posted:
2009-04-08
First Post:
2009-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Responses and Sensory Characteristics of Whole Yellow Pea Flour Added to Novel Functional Foods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'lastUpdateSubmitDate': '2009-04-07', 'studyFirstSubmitDate': '2009-04-07', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-prandial glycemic response'}], 'secondaryOutcomes': [{'measure': 'Comparison of hedonic sensory characteristics between corresponding food products'}, {'measure': 'Appearance, taste, texture, smell and overall acceptability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pea flour', 'Glycemic response', 'Diabetes', 'Sensory', 'Functional food', 'Diabetes control and prevention'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '20492127', 'type': 'DERIVED', 'citation': 'Marinangeli CP, Kassis AN, Jones PJ. Glycemic responses and sensory characteristics of whole yellow pea flour added to novel functional foods. J Food Sci. 2009 Nov-Dec;74(9):S385-9. doi: 10.1111/j.1750-3841.2009.01347.x.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to determine if whole yellow pea flour reduces post-prandial glycemic responses of novel food products. The second objective was to determine if whole yellow pea flour produces food products with favorable sensory characteristics including appearance, taste, smell, texture and overall acceptability, compared to corresponding food products made with whole wheat flour.', 'detailedDescription': 'Pulses, including yellow peas, are readily available and low-cost commodities that are gaining considerable momentum as functional ingredients possessing health benefits, as these food materials are high in fiber, protein, antioxidants, and low in fat. As incidence rates of type II diabetes continue to climb, new novel ingredients that produce low-glycemic food products are in demand. Consumption of whole pulses have been shown to lower post-prandial glycemic responses (Jenkins and others 1983), however, their addition to foods often produces unfavorable sensory characteristics. To date, few studies have examined the feasibility of producing food products containing pulse-derived ingredients that reduce post-prandial glycemic responses, lower glycemic indexes (GI) and at the same time possess sensory qualities that appeal to consumers. Since yellow peas are readily available and relatively inexpensive, they are a promising candidate for use as novel ingredients for the development of low-glycemic, consumer-friendly functional foods.\n\nThe objective of the present study was to first determine the post-prandial glycemic response and GI of novel foods containing whole yellow pea flour (WYPF) as a functional ingredient. The second objective was to determine the acceptability of sensory characteristics for each WYPF food product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy men\n* non-lactating women\n* BMI's between 18 and 31 kg/m2\n\nExclusion Criteria:\n\n* heart disease\n* diabetes\n* thyroid disease\n* celiac disease\n* gluten intolerance\n* taking corticosteroid medications\n* smokers\n* Chronic alcohol usage (\\> 2 drinks/d)"}, 'identificationModule': {'nctId': 'NCT00877968', 'briefTitle': 'Glycemic Responses and Sensory Characteristics of Whole Yellow Pea Flour Added to Novel Functional Foods', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Glycemic Responses and Sensory Characteristics of Whole Yellow Pea Flour Added to Novel Functional Foods', 'orgStudyIdInfo': {'id': 'B2008:017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Whole wheat banana bread', 'description': 'Banana bread made with whole wheat flour', 'interventionNames': ['Dietary Supplement: Whole wheat banana bread']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole pea flour banana bread', 'description': 'Banana bread made with whole pea flour', 'interventionNames': ['Dietary Supplement: Whole pea flour banana bread']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Whole wheat biscotti', 'description': 'Biscotti made with whole wheat flour', 'interventionNames': ['Dietary Supplement: Whole wheat biscotti']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole pea biscotti', 'description': 'Biscotti made with whole pea flour', 'interventionNames': ['Dietary Supplement: Whole pea flour biscotti']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Whole wheat pasta', 'description': 'Pasta made with whole wheat durum', 'interventionNames': ['Dietary Supplement: Whole wheat pasta']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole pea flour', 'description': 'Pasta made with 30% whole pea flour and 70% white wheat durum', 'interventionNames': ['Dietary Supplement: Whole pea pasta']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'White bread', 'interventionNames': ['Dietary Supplement: White bread']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Boiled yellow peas', 'interventionNames': ['Dietary Supplement: Boiled yellow peas']}], 'interventions': [{'name': 'Whole wheat banana bread', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose was portioned so that subjects received 50 g available carbohydrate\n\nPortion: 62.8 g Available CHO: 51.7 g', 'armGroupLabels': ['Whole wheat banana bread']}, {'name': 'Whole pea flour banana bread', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose was portioned so that subjects received 50 g available carbohydrate\n\nPortion: 67.8 g Available CHO: 52.0 g', 'armGroupLabels': ['Whole pea flour banana bread']}, {'name': 'Whole wheat biscotti', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose was portioned so that subjects received 50 g available carbohydrate\n\nPortion: 79.8 g Available CHO: 53.1 g', 'armGroupLabels': ['Whole wheat biscotti']}, {'name': 'Whole pea flour biscotti', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose was portioned so that subjects received 50 g available carbohydrate\n\nPortion: 86 g Available CHO: 51.7 g', 'armGroupLabels': ['Whole pea biscotti']}, {'name': 'Whole wheat pasta', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose was portioned so that subjects received 50 g available carbohydrate\n\nPortion (Dry): 70 g Available CHO: 51.1 g', 'armGroupLabels': ['Whole wheat pasta']}, {'name': 'Whole pea pasta', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose was portioned so that subjects received 50 g available carbohydrate Pea pasta is 30% whole pea pasta, 70 white wheat durum\n\nPortion (Dry pasta) : 90 g Available CHO: 53.1 g', 'armGroupLabels': ['Whole pea flour']}, {'name': 'White bread', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose was portioned so that subjects received 50 g available carbohydrate\n\nPortion: 100 g Available CHO: 50 g', 'armGroupLabels': ['White bread']}, {'name': 'Boiled yellow peas', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dose was portioned so that subjects received 50 g available carbohydrate\n\nPortion: 100 g (dry) --\\> 250 g cooked Available CHO: 52.8 g', 'armGroupLabels': ['Boiled yellow peas']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3T 2N2', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Richardson Centre for Functional Foods and Nutraceuticals', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Peter JH Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pulse Canada', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Peter J.H. Jones Professor', 'oldOrganization': 'University of Manitoba'}}}}