Skip to content

The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02630667
Enrollment
113
Registered
2015-12-15
Start date
2012-06-30
Completion date
Unknown
Last updated
2016-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Ability, General, Dietary Modification

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.

Interventions

OTHERSLOW Carbohydrate

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

OTHERMEDIUM Carbohydrate

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

OTHERFAST Carbohydrate

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

Sponsors

Abbott Nutrition
CollaboratorINDUSTRY
University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Cognitive Control at 15 minutes Postprandial15 minutes PostprandialPerformance 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 Postprandial70 minutes PostprandialPerformance 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

MeasureTime frameDescription
Change in Relational Memory at 30 minutes Postprandial30 minutes PostprandialPerformance 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.
Change in Relational Memory at 85 minutes Postprandial85 minutes PostprandialPerformance 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026