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The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition

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ClinicalTrials.gov Identifier: NCT02630667
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : December 8, 2016
Sponsor:
Collaborator:
Abbott Nutrition
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

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).

Condition or disease Intervention/treatment Phase
Cognitive Ability, General Dietary Modification Other: SLOW Carbohydrate Other: MEDIUM Carbohydrate Other: FAST Carbohydrate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: The Acute Effects of Fortified Nutritional Supplementation on Cognition, Memory, & Achievement
Study Start Date : June 2012
Actual Primary Completion Date : May 2016

Arm Intervention/treatment
Experimental: SLOW Carbohydrate
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response.
Other: SLOW Carbohydrate
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response

Experimental: MEDIUM Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response.
Other: MEDIUM Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response

Experimental: FAST Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response.
Other: FAST Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response

Placebo Comparator: Non-Caloric Placebo
Non-caloric placebo consisting of artificial sweeteners
Other: SLOW Carbohydrate
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response

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

Other: FAST Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   9 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630667


Locations
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United States, Illinois
Department of Kinesiology and Community Health
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Abbott Nutrition
Investigators
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Principal Investigator: Charles Hillman, PhD University of Illinois at Urbana-Champaign
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02630667    
Other Study ID Numbers: 12641
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016