Overview

This trial is active, not recruiting.

Conditions cognitive ability, general, dietary modification
Treatments slow carbohydrate, medium carbohydrate, fast carbohydrate
Sponsor University of Illinois at Urbana-Champaign
Collaborator Abbott Nutrition
Start date June 2012
End date May 2016
Trial size 113 participants
Trial identifier NCT02630667, 12641

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Arm
(Experimental)
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response.
slow carbohydrate
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response
(Experimental)
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response.
medium carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response
(Experimental)
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response.
fast carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response
(Placebo Comparator)
Non-caloric placebo consisting of artificial sweeteners
slow carbohydrate
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response
medium carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response
fast carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response

Primary Outcomes

Measure
Change in Cognitive Control at 15 minutes Postprandial
time frame: 15 minutes Postprandial
Change in Cognitive Control at 70 minutes Postprandial
time frame: 70 minutes Postprandial

Secondary Outcomes

Measure
Change in Relational Memory at 30 minutes Postprandial
time frame: 30 minutes Postprandial
Change in Relational Memory at 85 minutes Postprandial
time frame: 85 minutes Postprandial

Eligibility Criteria

Male or female participants from 9 years up to 10 years old.

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

Additional Information

Official title The Acute Effects of Fortified Nutritional Supplementation on Cognition, Memory, & Achievement
Principal investigator Charles Hillman, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign.