Clinical trial NCT02630667: The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition
Official title: The Acute Effects of Fortified Nutritional Supplementation on Cognition, Memory, & Achievement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Ability, General
Dietary Modification
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Abbott Nutrition
First posted: 2015-12-15
Enrollment: 113
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Change in Cognitive Control at 15 minutes Postprandial
timeFrame: 15 minutes Postprandial
measure: Change in Cognitive Control at 70 minutes Postprandial
timeFrame: 70 minutes Postprandial
Secondary outcomes:
measure: Change in Relational Memory at 30 minutes Postprandial
timeFrame: 30 minutes Postprandial
measure: Change in Relational Memory at 85 minutes Postprandial
timeFrame: 85 minutes Postprandial
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Department of Kinesiology and Community Health
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Charles Hillman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.