Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT02630667
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2015-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition
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']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'lastUpdateSubmitDate': '2016-12-07', 'studyFirstSubmitDate': '2015-08-25', 'studyFirstSubmitQcDate': '2015-12-10', 'lastUpdatePostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cognitive Control at 15 minutes Postprandial', 'timeFrame': '15 minutes Postprandial', 'description': 'Performance will be assessed using the difference in inverse efficiency (during a modified flanker task) between performance at 15 minutes and baseline/fasted (within 2 hours of wake-time) performance.'}, {'measure': 'Change in Cognitive Control at 70 minutes Postprandial', 'timeFrame': '70 minutes Postprandial', 'description': 'Performance will be assessed using the difference in inverse efficiency (during a modified flanker task) between performance at 70 minutes and baseline/fasted (within 2 hours of wake-time).'}], 'secondaryOutcomes': [{'measure': 'Change in Relational Memory at 30 minutes Postprandial', 'timeFrame': '30 minutes Postprandial', 'description': 'Performance will be assessed using the difference in number of swap errors (during a spatial reconstruction task) by calculating the difference between number of errors performed at baseline/fasted (within 2 hours of wake-time) from number of errors at 30 minutes postprandial.'}, {'measure': 'Change in Relational Memory at 85 minutes Postprandial', 'timeFrame': '85 minutes Postprandial', 'description': 'Performance will be assessed using the difference in number of swap errors (during a spatial reconstruction task) by calculating the difference between number of errors performed at baseline/fasted (within 2 hours of wake-time) from number of errors at 85 minutes postprandial.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cognitive Ability, General', 'Dietary Modification']}, 'referencesModule': {'references': [{'pmid': '31756405', 'type': 'DERIVED', 'citation': 'Walk AM, Raine LB, Kramer AF, Cohen NJ, Hillman CH, Khan NA. Adiposity is related to neuroelectric indices of motor response preparation in preadolescent children. Int J Psychophysiol. 2020 Jan;147:176-183. doi: 10.1016/j.ijpsycho.2019.10.014. Epub 2019 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the acute effects of ingestion of carbohydrates - with different glycemic profiles - on cognitive function among preadolescent children (i.e., 9-10 years).', 'detailedDescription': "Regular breakfast consumption is linked to improved cognitive performance in school-aged children. However, the acute benefits of defined nutrient consumption on brain and cognitive health are not well understood, particularly in preadolescent children. One factor that may relate to brain health and learning in children is the contribution of carbohydrates to the digestion rate of a meal (and associated effects on post-prandial glycemia).\n\nThe effects of differentially absorbed carbohydrates on brain and cognition are unknown, especially when ingested via a fortified nutritional beverage providing a balanced array of nutrients. The aim of this study is to investigate the acute, transient effect of nutrient supplementation with varied carbohydrate systems in preadolescent children (i.e., 9-10 years).\n\nParticipants will be randomized to receive one of three treatment nutritional formulations containing carbohydrates with varying absorption rates along with a non-caloric placebo. Participants will perform a cognitive battery in the fasted condition, shortly after treatment ingestion, and an hour after ingestion. Group differences in performance will be contrasted to assess the effects of different carbohydrate types on children's cognitive function following an overnight fast.\n\nFindings from this study will inform our understanding of the macronutrient profile of breakfast that may potentially improve children's cognitive performance in the morning."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parental/guardian consent.\n* Participants must be between the ages of 9-10 years old at the time of testing age\n* Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).\n* Participants must have an IQ \\> 85 (IQ \\< 85).\n\nExclusion Criteria:\n\n* Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, and dependence upon a wheelchair/walking aid, and ADHD Rating Scale score below 85%).\n* Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications).\n* Early pubertal status, as measured by a modified test of the Tanner Staging System (onset of puberty as determined by Tanner).\n* Lactose intolerance\n* Allergies to milk and/or soy\n* Adherence to a strict vegan diet'}, 'identificationModule': {'nctId': 'NCT02630667', 'briefTitle': 'The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'The Acute Effects of Fortified Nutritional Supplementation on Cognition, Memory, & Achievement', 'orgStudyIdInfo': {'id': '12641'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLOW Carbohydrate', 'description': 'Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response.', 'interventionNames': ['Other: SLOW Carbohydrate']}, {'type': 'EXPERIMENTAL', 'label': 'MEDIUM Carbohydrate', 'description': 'Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response.', 'interventionNames': ['Other: MEDIUM Carbohydrate']}, {'type': 'EXPERIMENTAL', 'label': 'FAST Carbohydrate', 'description': 'Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response.', 'interventionNames': ['Other: FAST Carbohydrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-Caloric Placebo', 'description': 'Non-caloric placebo consisting of artificial sweeteners', 'interventionNames': ['Other: SLOW Carbohydrate', 'Other: MEDIUM Carbohydrate', 'Other: FAST Carbohydrate']}], 'interventions': [{'name': 'SLOW Carbohydrate', 'type': 'OTHER', 'description': 'Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response', 'armGroupLabels': ['Non-Caloric Placebo', 'SLOW Carbohydrate']}, {'name': 'MEDIUM Carbohydrate', 'type': 'OTHER', 'description': 'Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response', 'armGroupLabels': ['MEDIUM Carbohydrate', 'Non-Caloric Placebo']}, {'name': 'FAST Carbohydrate', 'type': 'OTHER', 'description': 'Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response', 'armGroupLabels': ['FAST Carbohydrate', 'Non-Caloric Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Department of Kinesiology and Community Health', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}], 'overallOfficials': [{'name': 'Charles Hillman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Urbana-Champaign'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}