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Completed

NCT Number: NCT02630667

The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition

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).

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Key information

Age range

9 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Kinesiology and Community Health

Urbana, Illinois, 61801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLOW Carbohydrate

Other

Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response

MEDIUM Carbohydrate

Other

Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response

FAST Carbohydrate

Other

Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • Abbott Nutrition

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
First posted
Dec 15, 2015
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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