The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition

December 7, 2016 updated by: University of Illinois at Urbana-Champaign

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Department of Kinesiology and Community Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SLOW Carbohydrate
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response.
Other: SLOW Carbohydrate
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response
Experimental: MEDIUM Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response.
Other: MEDIUM Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response
Experimental: FAST Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response.
Other: FAST Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response
Placebo Comparator: Non-Caloric Placebo
Non-caloric placebo consisting of artificial sweeteners
Other: SLOW Carbohydrate
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response
Other: MEDIUM Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response
Other: FAST Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes Postprandial
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).
70 minutes Postprandial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Relational Memory at 30 minutes Postprandial
Time Frame: 30 minutes Postprandial
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.
30 minutes Postprandial
Change in Relational Memory at 85 minutes Postprandial
Time Frame: 85 minutes Postprandial
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.
85 minutes Postprandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

Abbott Nutrition

Investigators

  • Principal Investigator: Charles Hillman, PhD, University of Illinois at Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 12641

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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