Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-28 @ 5:40 AM
Study NCT ID:
NCT01410851
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2011-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulses, Satiation, Food Intake and Blood Glucose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2011-07-27', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-term energy intake', 'timeFrame': 'over 280 min', 'description': 'Energy intake was measured at the treatment meal (0-20 min) and at a pizza meal (second meal) provided four hours later (260-280 min).'}], 'secondaryOutcomes': [{'measure': 'Blood glucose and satiety', 'timeFrame': '20, 40, 60, 110, 140, 200, 260, 280, 300, 320 and 340 min', 'description': 'Following treatment meal consumption, blood glucose and appetite were measured at 20, 40, 60, 110, 140, 200 and 260 min and are reported as pre-second meal values. Following the pizza meal, blood glucose and appetite were measured at 280, 300, 320 and 340 min and are reported as post-second meal values.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Pulses have the potential to be positioned as a food for body weight and metabolic control based on their composition, effects on rate of digestion and absorption of fat and carbohydrates, and effects on satiety. However, the role of individual pulses incorporated into a mixed meal on regulation of food intake, satiety and glycaemic control remains unclear. Therefore, the objective of our study was to determine the effects of ad libitum consumption of pulse meals (treatments) on food intake at an ad libitum pulse meal, food intake at an ad libitum pizza meal at four hours, subjective appetite and blood glucose.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy young males with BMI of 20-24.9 kg/m2\n\nExclusion Criteria:\n\n* Females\n* Smokers\n* Breakfast skippers\n* Individuals with diabetes or other metabolic diseases\n* Those scoring ≥ 11 on an Eating Habit Questionnaire'}, 'identificationModule': {'nctId': 'NCT01410851', 'briefTitle': 'Pulses, Satiation, Food Intake and Blood Glucose', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'The Acute Effects of Pulse Consumption on Glycaemic Responses and Measures of Satiety and Satiation', 'orgStudyIdInfo': {'id': 'PURENet:-Pulses and Satiation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pasta, tomato sauce & added chickpeas', 'description': 'The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (\\~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.', 'interventionNames': ['Other: dietary treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Pasta, tomato sauce and added lentils', 'description': 'The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (\\~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.', 'interventionNames': ['Other: dietary treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Pasta, tomato sauce and added navy beans', 'description': 'The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (\\~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.', 'interventionNames': ['Other: dietary treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Pasta, tomato sauce with yellow peas', 'description': 'The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (\\~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.', 'interventionNames': ['Other: dietary treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Pasta and tomato sauce', 'description': 'The pulse treatments and control (pasta with tomato sauce) were made the day before the session and the recipe was calculated to provide 1500 kcal at each session. All meals had the same energy density (\\~77kcal/100g). Calories derived from pulses were consistent among all pulse treatments (44%). The pulse treatments and control all contained macaroni pasta and homemade tomato sauce.', 'interventionNames': ['Other: dietary treatment']}], 'interventions': [{'name': 'dietary treatment', 'type': 'OTHER', 'description': 'A within-subject, balanced repeated-measures design was followed where subjects received 4 treatments or control over 5 weeks approximately 1 week apart. The pulse treatments contained: (1) chickpeas (Primo, Toronto, ON), (2) lentils (Primo, Toronto, ON), (3) navy beans (Ferma, Toronto, ON) or (4) yellow peas (Nupak, Toronto, ON).', 'armGroupLabels': ['Pasta and tomato sauce', 'Pasta, tomato sauce & added chickpeas', 'Pasta, tomato sauce and added lentils', 'Pasta, tomato sauce and added navy beans', 'Pasta, tomato sauce with yellow peas']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 3E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Department of Nutritional Sciences, University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'G. Harvey Anderson, PhD', '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'}], 'responsibleParty': {'oldNameTitle': 'G. Harvey Anderson, Ph.D., Professor', 'oldOrganization': 'University of Toronto'}}}}