The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognitive Ability, General, Dietary Modification

Intervention / Treatment
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* Other: SLOW Carbohydrate
* Other: MEDIUM Carbohydrate
* Other: FAST Carbohydrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLOW Carbohydrate<br>Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response. | Other: SLOW Carbohydrate<br>* Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response<br>|
| Experimental: MEDIUM Carbohydrate<br>Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response. | Other: MEDIUM Carbohydrate<br>* Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response<br>|
| Experimental: FAST Carbohydrate<br>Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response. | Other: FAST Carbohydrate<br>* Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response<br>|
| Placebo Comparator: Non-Caloric Placebo<br>Non-caloric placebo consisting of artificial sweeteners | Other: SLOW Carbohydrate<br>* Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response<br>Other: MEDIUM Carbohydrate<br>* Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response<br>Other: FAST Carbohydrate<br>* Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |