Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-04-10 @ 3:26 AM
Study NCT ID:
NCT00621595
Status:
COMPLETED
Last Update Posted:
2015-09-11
First Post:
2008-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Breakfast on Brain Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-09', 'studyFirstSubmitDate': '2008-02-12', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['School Breakfast', 'Diet', 'Nutrition', 'Brain Function', 'Cognition', 'USDA', 'Healthy Children'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To test cognitive abilities of 8-11 year old children under conditions of fasting or receiving a full school breakfast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8-11 years old\n* Between 25th and 95th percentile, BMI-for-age\n\nExclusion Criteria:\n\n* food allergies or some intolerances\n* uncorrected vision\n* IQ \\< 80\n* Other chronic conditions thought to interfere with the study as determined by the investigator'}, 'identificationModule': {'nctId': 'NCT00621595', 'briefTitle': 'The Effects of Breakfast on Brain Function', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'The Effects of Breakfast on Cognitive Functioning', 'orgStudyIdInfo': {'id': '06278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Fasting', 'interventionNames': ['Dietary Supplement: USDA School Breakfast']}], 'interventions': [{'name': 'USDA School Breakfast', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Breakfast containing 340 calories, 57 g carbohydrate, 14 g protein, 6 g fat.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Nutrition Center", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'R Terry Pivik, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas for Medial Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'R. Terry Pivik, Ph.D. / Principal Investigator', 'oldOrganization': 'University of Arkansas for Medical Science'}}}}