Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-10 @ 6:17 PM
Study NCT ID:
NCT03223935
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2017-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Roasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, controlled cross-over acute trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2017-07-06', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food intake', 'timeFrame': 'At 60 min', 'description': 'Ab libitum meal'}], 'secondaryOutcomes': [{'measure': 'Subjective appetite', 'timeFrame': '0-200 min', 'description': 'Measured by VAS questionnaire at 12 time points used to calculate area under the curve'}, {'measure': 'Blood glucose concentrations', 'timeFrame': '0-200 min', 'description': 'Measured in blood using a glucometer at 12 time points and used to calculate area under the curve'}, {'measure': 'Physical comfort', 'timeFrame': '0-200 min', 'description': 'Measured by VAS questionnaire at 12 time points to calculate area under the curve'}, {'measure': 'Energy and fatigue', 'timeFrame': '0-200 min', 'description': 'Measured by VAS questionnaire at 12 time points to calculate area under the curve'}, {'measure': 'Palatability of meal', 'timeFrame': 'At 60 min', 'description': 'Measured by VAS questionnaire'}, {'measure': 'Palatability of treatment', 'timeFrame': 'At 5 min', 'description': 'Measured by VAS questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Normal Weight', 'Overweight', 'Normoglycemic']}, 'descriptionModule': {'briefSummary': 'An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults.', 'detailedDescription': 'An acute, randomized, controlled cross-over trial examining the post-prandial glycemic and satiety response to six snacks will be conducted. The study treatments are: 1) roasted corn nuts, 2) roasted chickpeas, 3) roasted yellow peas, 4) roasted pinto beans 5) roasted soybeans, and 6) roasted almonds. They will be matched for calorie content and provided in 200 kcal servings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI: ≥18.5 and ≤29.9 kg/m2\n* Fasting serum glucose: ≤5.5 mmol/L\n\nExclusion Criteria:\n\n* Fasting serum glucose \\> 5.5 mmol/L\n* Smoking\n* Thyroid problems\n* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease\n* Presence of a gastrointestinal disorder or surgeries within the past year\n* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment\n* Known to be pregnant or lactating\n* Known intolerance, sensitivity or allergy to any ingredients in the study products.\n* Extreme dietary habits (i.e. Atkins diet, very high protein diets, etc.)\n* Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)\n* Weight gain or loss of at least 10lbs in previous three months\n* Excessive alcohol intake\n* Restrained Eaters (identified by Eating Habits Questionnaire)"}, 'identificationModule': {'nctId': 'NCT03223935', 'briefTitle': 'Roasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'A Comparison of Roasted Pulse Snacks on Post-prandial Food Intake, Appetite, and Glycemic Response in Healthy Young Adults', 'orgStudyIdInfo': {'id': 'HS20792 (B2017:059)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Roasted snacks', 'description': 'Corn nuts', 'interventionNames': ['Other: Corn nuts']}, {'type': 'EXPERIMENTAL', 'label': 'Roasted chickpeas', 'description': 'Chickpeas', 'interventionNames': ['Other: Chickpeas']}, {'type': 'EXPERIMENTAL', 'label': 'Roasted yellow peas', 'description': 'Yellow peas', 'interventionNames': ['Other: Yellow peas']}, {'type': 'EXPERIMENTAL', 'label': 'Roasted pinto beans', 'description': 'Pinto beans', 'interventionNames': ['Other: Pinto beans']}, {'type': 'EXPERIMENTAL', 'label': 'Roasted soybeans', 'description': 'Soybeans', 'interventionNames': ['Other: Soybeans']}, {'type': 'EXPERIMENTAL', 'label': 'Roasted almonds', 'description': 'Almonds', 'interventionNames': ['Other: Almonds']}], 'interventions': [{'name': 'Corn nuts', 'type': 'OTHER', 'description': 'Roasted corn nut snack', 'armGroupLabels': ['Roasted snacks']}, {'name': 'Chickpeas', 'type': 'OTHER', 'description': 'Roasted chickpea snack', 'armGroupLabels': ['Roasted chickpeas']}, {'name': 'Yellow peas', 'type': 'OTHER', 'description': 'Roasted yellow pea snack', 'armGroupLabels': ['Roasted yellow peas']}, {'name': 'Pinto beans', 'type': 'OTHER', 'description': 'Roasted pinto bean snack', 'armGroupLabels': ['Roasted pinto beans']}, {'name': 'Soybeans', 'type': 'OTHER', 'description': 'Roasted soybean snack', 'armGroupLabels': ['Roasted soybeans']}, {'name': 'Almonds', 'type': 'OTHER', 'description': 'Roasted almond snack', 'armGroupLabels': ['Roasted almonds']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3T 6C5', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Peter JH Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data requests should be submitted to the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Saskatchewan Pulse Growers', 'class': 'OTHER'}, {'name': 'Pulse Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}