Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-28 @ 6:05 AM
Study NCT ID:
NCT01242059
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2010-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yellow Pea Fractions and Short-term Food Intake, Subjective Appetite and Glycemic Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-13', 'studyFirstSubmitDate': '2010-11-12', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy Intake', 'timeFrame': 'at 120 minutes after treatment', 'description': 'Energy intake at an ad libitum pizza meal'}], 'secondaryOutcomes': [{'measure': 'Glycemic Response', 'timeFrame': '200 minutes'}, {'measure': 'Subjective Appetite', 'timeFrame': '200 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Food intake regulation', 'blood glucose regulation', 'protein', 'fiber', 'pulses', 'yellow peas'], 'conditions': ['Obesity', 'Type II Diabetes Mellitus', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'It is hypothesized that yellow pea protein and fiber will reduce short-term food intake, subjective appetite and glycemic response.', 'detailedDescription': 'A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10 or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea fractions. Food intake was measured at an ad libitum pizza meal served 2 hours after treatment. Satiety and blood glucose (via finger prick) were measured throughout the treatment period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male 20-30 years old healthy weight\n\nExclusion Criteria:\n\n* smoking restrictive eating metabolic diseases breakfast skippers dieters'}, 'identificationModule': {'nctId': 'NCT01242059', 'briefTitle': 'Yellow Pea Fractions and Short-term Food Intake, Subjective Appetite and Glycemic Response', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Effect of Yellow Pea Fractions on Short-term Food Intake at 120 Minutes, Subjective Appetite and Glycemic Response in Young Adult Males', 'orgStudyIdInfo': {'id': 'PureNet_23281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control Tomato Soup', 'interventionNames': ['Dietary Supplement: Control']}, {'type': 'EXPERIMENTAL', 'label': '10 g of yellow pea fiber', 'interventionNames': ['Other: yellow pea fiber']}, {'type': 'EXPERIMENTAL', 'label': '20 g of yellow pea fiber', 'interventionNames': ['Other: yellow pea fiber']}, {'type': 'EXPERIMENTAL', 'label': '10 g of yellow pea protein', 'interventionNames': ['Dietary Supplement: yellow pea protein']}, {'type': 'EXPERIMENTAL', 'label': '20 g of yellow pea protein', 'interventionNames': ['Dietary Supplement: yellow pea protein']}], 'interventions': [{'name': 'yellow pea protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Served in a tomato soup', 'armGroupLabels': ['10 g of yellow pea protein', '20 g of yellow pea protein']}, {'name': 'yellow pea fiber', 'type': 'OTHER', 'description': 'Served in a tomato soup', 'armGroupLabels': ['10 g of yellow pea fiber', '20 g of yellow pea fiber']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Served in a tomato soup', 'armGroupLabels': ['Control Tomato Soup']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 3E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto - Department of Nutritional Sciences', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'G Harvey Anderson, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agriculture and Agri-Food Canada', 'class': 'OTHER_GOV'}, {'name': 'Pulse Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'G. Harvey Anderson', 'investigatorAffiliation': 'University of Toronto'}}}}