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Clinical Trials/NCT02630667
NCT02630667
Completed
Not Applicable

The Acute Effects of Fortified Nutritional Supplementation on Cognition, Memory, & Achievement

University of Illinois at Urbana-Champaign1 site in 1 country113 target enrollmentJune 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Ability, General
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
113
Locations
1
Primary Endpoint
Change in Cognitive Control at 15 minutes Postprandial
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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).

Detailed Description

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). The 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). Participants 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. Findings from this study will inform our understanding of the macronutrient profile of breakfast that may potentially improve children's cognitive performance in the morning.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Parental/guardian consent.
  • Participants must be between the ages of 9-10 years old at the time of testing age
  • Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
  • Participants must have an IQ \> 85 (IQ \< 85).

Exclusion Criteria

  • 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%).
  • 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).
  • Early pubertal status, as measured by a modified test of the Tanner Staging System (onset of puberty as determined by Tanner).
  • Lactose intolerance
  • Allergies to milk and/or soy
  • Adherence to a strict vegan diet

Outcomes

Primary Outcomes

Change in Cognitive Control at 15 minutes Postprandial

Time Frame: 15 minutes Postprandial

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.

Change in Cognitive Control at 70 minutes Postprandial

Time Frame: 70 minutes Postprandial

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).

Secondary Outcomes

  • Change in Relational Memory at 30 minutes Postprandial(30 minutes Postprandial)
  • Change in Relational Memory at 85 minutes Postprandial(85 minutes Postprandial)

Study Sites (1)

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