The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition

University of Illinois at Urbana-Champaign

Status: Completed

Conditions: Dietary Modification; Cognitive Ability, General

Treatments: Other: FAST Carbohydrate; Other: MEDIUM Carbohydrate; Other: SLOW Carbohydrate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02630667

12641

Details and patient eligibility

About

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).

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 9 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

113 participants in 4 patient groups, including a placebo group

SLOW Carbohydrate

Experimental group

Description:

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

Treatment:

Other: SLOW Carbohydrate

MEDIUM Carbohydrate

Experimental group

Description:

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

Treatment:

Other: MEDIUM Carbohydrate

FAST Carbohydrate

Experimental group

Description:

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

Treatment:

Other: FAST Carbohydrate

Non-Caloric Placebo

Placebo Comparator group

Description:

Non-caloric placebo consisting of artificial sweeteners

Treatment:

Other: SLOW Carbohydrate

Other: FAST Carbohydrate

Other: MEDIUM Carbohydrate