Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-17 @ 1:07 AM
Study NCT ID:
NCT02820805
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Carbohydrate Consumption on Memory Performance and Mood in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C508416', 'term': 'lunatusin, Phaseolus lunatus'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-07', 'studyFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2016-06-28', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive performance', 'timeFrame': '10, 30, 60, 120, 180 minutes after meal consumption', 'description': 'Participants will participate in a battery of tests that include two learning and memory tasks and two attention tasks at 10, 30, 60, 120, and 180 minutes after meal consumption.'}], 'secondaryOutcomes': [{'measure': 'Blood glucose response', 'timeFrame': 'Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption', 'description': 'Blood will be collected at baseline, 10, 30, 60, 120, and 180 minutes after meal consumption to observe glycemic responses to 50g available carbohydrates from mashed potatoes, potato pancakes, French fries, rice, or beans'}, {'measure': 'Subjective Appetite and Mood', 'timeFrame': 'Baseline, 10, 30, 60, 120, and 180 minutes after meal consumption', 'description': 'Participants will complete subjective ratings on appetite (e.g., desire to eat, hunger, fullness) and mood (e.g. anger, happiness, excitement, sleepiness) at baseline, 10, 30, 60, 120, and 180 minutes after meal consumption.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['children', 'dietary carbohydrates', 'solanum tuberosum', 'cognition', 'memory', 'emotions', 'blood glucose'], 'conditions': ['Cognitive Ability, General']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of carbohydrates on blood glucose levels, subjective appetite, mood, and memory performance in 9 to 14 year old normal weight (NW) and overweight or obese (OW/OB) children.', 'detailedDescription': 'NW and OW/OB children, 9-14 years of age, will participate in the experiment. The effect of 5 different meals (mashed potatoes, hash browns, French fries, rice, or beans matched by 50g of available carbohydrate) and meal skipping will be examined. On six separate mornings, one of the meals or no meal will be provided in a random order upon their arrival. Blood glucose, subjective appetite, and mood will be measured at baseline, 10, 30, 60, 120, and 180 minutes after meal consumption. Cognitive performance will be measured using an immediate and delayed word recall test, and two to three executive function tasks at 10, 30, 60, 120, and 180 minutes after meal consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be between 9 and 14 years of age\n* be healthy, and have been born at term\n* be a native English speaker\n* not be taking any medications\n* not have allergies to potatoes, rice, or beans.\n* normal body weight (between the 5th and 85th BMI percentile for age and gender)\n* OW/OB (\\>85th BMI percentile for age and gender)\n\nExclusion Criteria:\n\n* Food sensitivities, allergies, or dietary restrictions\n* Health, learning, emotional, or behaivoural problems\n* Receiving any medications'}, 'identificationModule': {'nctId': 'NCT02820805', 'briefTitle': 'Dietary Carbohydrate Consumption on Memory Performance and Mood in Children', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Metropolitan University'}, 'officialTitle': 'The Effect of Dietary Carbohydrate Consumption on Memory Performance and Mood in Normal Weight and Overweight/Obese Children', 'orgStudyIdInfo': {'id': 'REB2016-060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal skipping', 'description': 'No meal given', 'interventionNames': ['Other: Meal Skipping']}, {'type': 'EXPERIMENTAL', 'label': 'Mashed potatoes', 'description': 'Carbohydrate Test Meal (50 g of available carbohydrates)', 'interventionNames': ['Other: Mashed potatoes']}, {'type': 'EXPERIMENTAL', 'label': 'French fries', 'description': 'Carbohydrate Test Meal (50 g of available carbohydrates)', 'interventionNames': ['Other: French fries']}, {'type': 'EXPERIMENTAL', 'label': 'Hash browns', 'description': 'Carbohydrate Test Meal (50 g of available carbohydrates)', 'interventionNames': ['Other: Hash browns']}, {'type': 'EXPERIMENTAL', 'label': 'Rice', 'description': 'Carbohydrate Test Meal (50 g of available carbohydrates)', 'interventionNames': ['Other: Rice']}, {'type': 'EXPERIMENTAL', 'label': 'Beans', 'description': 'Carbohydrate Test Meal (50 g of available carbohydrates)', 'interventionNames': ['Other: Beans']}], 'interventions': [{'name': 'Meal Skipping', 'type': 'OTHER', 'description': 'No meal', 'armGroupLabels': ['Meal skipping']}, {'name': 'French fries', 'type': 'OTHER', 'description': '50g of available carbohydrates meal', 'armGroupLabels': ['French fries']}, {'name': 'Mashed potatoes', 'type': 'OTHER', 'description': '50g of available carbohydrates meal', 'armGroupLabels': ['Mashed potatoes']}, {'name': 'Hash browns', 'type': 'OTHER', 'description': '50g of available carbohydrates meal', 'armGroupLabels': ['Hash browns']}, {'name': 'Rice', 'type': 'OTHER', 'description': '50g of available carbohydrates meal', 'armGroupLabels': ['Rice']}, {'name': 'Beans', 'type': 'OTHER', 'description': '50g of available carbohydrates meal', 'armGroupLabels': ['Beans']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'School of Nutrition, Ryerson University', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Nick Bellissimo, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Metropolitan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Nutrition', 'investigatorFullName': 'Nick Bellissimo', 'investigatorAffiliation': 'Toronto Metropolitan University'}}}}