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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02630667
Other study ID # 12641
Secondary ID
Status Completed
Phase N/A
First received August 25, 2015
Last updated December 7, 2016
Start date June 2012

Study information

Verified date December 2016
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Years to 10 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
United States Department of Kinesiology and Community Health Urbana Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Cognitive Control at 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 No
Primary Change in Cognitive Control at 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 No
Secondary Change in Relational Memory at 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 No
Secondary Change in Relational Memory at 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 No
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