Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-04-02 @ 1:59 PM
Study NCT ID:
NCT02402504
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2014-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PERFECT Project - Part 1 - Study 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2014-12-20', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Glucose and Insulin Concentrations', 'timeFrame': '0 - 200 min', 'description': 'Measured in blood using intravenous catheter at 12 time points and used to calculate area under curve (AUC). Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits (Composite measure)'}, {'measure': 'Food Intake', 'timeFrame': 'at 120 min', 'description': 'Ad-libitum meal'}, {'measure': 'Subjective Appetite', 'timeFrame': '0-200 min', 'description': 'Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) (Composite measure)'}], 'secondaryOutcomes': [{'measure': 'Palatability of treatments', 'timeFrame': 'at 5 minutes', 'description': 'Measured by VAS questionnaire'}, {'measure': 'Palatability of meal', 'timeFrame': 'at 140 minutes', 'description': 'Measured by VAS questionnaire'}, {'measure': 'Energy and Fatigue', 'timeFrame': '0-200 min', 'description': 'Measured by VAS questionnaire at 12 time points and use to calculate AUC. (Composite measure)'}, {'measure': 'Physical Comfort', 'timeFrame': '0-200 min', 'description': 'Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC). (Composite measure)'}]}, 'conditionsModule': {'conditions': ['Diabetes Prevention', 'Obesity Prevention']}, 'referencesModule': {'references': [{'pmid': '33347383', 'type': 'DERIVED', 'citation': 'Johnston AJ, Mollard RC, Dandeneau D, MacKay DS, Ames N, Curran J, Bouchard DR, Jones PJ. Acute effects of extruded pulse snacks on glycemic response, insulin, appetite, and food intake in healthy young adults in a double blind, randomized, crossover trial. Appl Physiol Nutr Metab. 2021 Jul;46(7):704-710. doi: 10.1139/apnm-2020-0572. Epub 2020 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'The objectives are to test the acute effects of different extruded pulse snacks on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products.\n\nThe investigators hypothesize that snack products containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normoglycemic (\\<5.6 mmol/L) and normotensive (systolic blood pressure \\<140 mm Hg and diastolic blood pressure below \\< 90 mm Hg)\n* BMI of 18.5-29.9 kg/m2\n\nExclusion Criteria:\n\n* Restrained eaters\n* Regularly skip breakfast\n* Smokers\n* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year\n* Competitive sports or athletic training at a high intensity\n* Those unable to walk for an hour continuously'}, 'identificationModule': {'nctId': 'NCT02402504', 'briefTitle': 'PERFECT Project - Part 1 - Study 1', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 1', 'orgStudyIdInfo': {'id': 'B2014:114-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Extruded snack control', 'description': '100% corn flour', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Extruded snack with small particle size pea flour', 'description': '60% corn flour and 40% small particle size pea flour', 'interventionNames': ['Other: Small particle size pea flour']}, {'type': 'EXPERIMENTAL', 'label': 'Extruded snack with large particle size pea flour', 'description': '60% corn flour and 40% large particle size pea flour', 'interventionNames': ['Other: Large particle size pea flour']}, {'type': 'EXPERIMENTAL', 'label': 'Extruded snack with lentil flour', 'description': '60% corn flour and 40% lentil flour', 'interventionNames': ['Other: Lentil flour']}, {'type': 'EXPERIMENTAL', 'label': 'Extruded snack navy bean flour', 'description': '60% corn flour and 40% navy bean flour', 'interventionNames': ['Other: Navy bean flour']}, {'type': 'EXPERIMENTAL', 'label': 'Extruded snack with pinto bean flour', 'description': '60% corn flour and 40% pinto bean flour', 'interventionNames': ['Other: Pinto bean flour']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': 'Non pulse extruded snack', 'armGroupLabels': ['Extruded snack control']}, {'name': 'Small particle size pea flour', 'type': 'OTHER', 'description': 'Pulse extruded snack', 'armGroupLabels': ['Extruded snack with small particle size pea flour']}, {'name': 'Large particle size pea flour', 'type': 'OTHER', 'description': 'Pulse extruded snack', 'armGroupLabels': ['Extruded snack with large particle size pea flour']}, {'name': 'Lentil flour', 'type': 'OTHER', 'description': 'Pulse extruded snack', 'armGroupLabels': ['Extruded snack with lentil flour']}, {'name': 'Navy bean flour', 'type': 'OTHER', 'description': 'Pulse extruded snack', 'armGroupLabels': ['Extruded snack navy bean flour']}, {'name': 'Pinto bean flour', 'type': 'OTHER', 'description': 'Pulse extruded snack', 'armGroupLabels': ['Extruded snack with pinto bean flour']}]}, '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, Richardson Centre for Functional Foods and Nutraceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Saskatchewan Pulse Growers', 'class': 'OTHER'}, {'name': 'Alberta Pulse Growers', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}