Effect of Dairy on Cognitive Performance in Children

Not Applicable

Completed

• Conditions: Children; Healthy
• Interventions: Other: Snack skipping; Other: Fruit juice; Other: Fat-free milk; Other: Fat-free yogurt; Other: Low-fat cheese

• Registration Number: NCT05767983
• Lead Sponsor: Toronto Metropolitan University

Brief Summary

The purpose of this study is to determine the effects of dairy consumption on short-term cognitive performance, subjective mood and emotions, and glycemic response in healthy children aged 9 - 14 years. The investigators hypothesize that the consumption of dairy products as a mid-morning snack will improve mood and cognitive performance in children. Furthermore, the investigators hypothesize that all dairy products consumed as a mid-morning snack will imbue more benefits on mood and cognitive performance over 2-hours compared to fruit juice or snack skipping.

Detailed Description

A randomized within-subject repeated measures experiment will be used to study the effects of dairy product consumption on cognitive performance, subjective mood and emotions, and blood glucose in healthy 9 - 14 year old children. Participants will consume, in a random order on separate mornings, one of the five treatments: (a) milk, (b) yogurt, (c) cheese, (d) fruit juice, or (e) snack skipping. Subjective mood/emotions and cognitive domains (learning and memory, spatial working memory, attention, processing speed, and executive function) will be assessed at baseline (0-min), and 15-, 30-, 60-, and 120-min following treatment consumption. Blood glucose measurements will be collected using the Freestyle Libre 2 continuous glucose monitoring system.

Study Timeline

• Study Start: 2022-10-18
• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-14
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 9 to 14 years of age;
• Normal weight defined as between the 15th and 80th percentile for age and biological sex at birth according to the World Health Organization growth (WHO) charts.

Exclusion Criteria

• Children with overweight/ obesity;
• Children with food sensitivities or allergies to dairy, gluten or any foods used in the study;
• Children with any diagnosed learning, emotional, or behavioural disabilities;
• Children taking any medications that may influence cognitive performance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Snack skipping	Snack skipping	Treatment
Fruit juice	Fruit juice	Treatment
Fat-free milk	Fat-free milk	Treatment
Fat-free yogurt	Fat-free yogurt	Treatment
Low-fat cheese	Low-fat cheese	Treatment

Primary Outcome Measures

Name	Time	Method
Learning and short-term memory	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption	Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Learning and short-term memory will be assessed using an immediate and delayed Word Recall Test (accuracy).
Sustained attention	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption	Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Sustained attention and processing speed will be assessed using the Continuous Performance Test (CPT) (accuracy and reaction time).
Spatial working memory	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption	Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Spatial working memory will be assessed using the forward and backward versions of the Corsi Block Test (accuracy).
Executive function	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption	Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Executive function and selective attention will be assessed using the Flanker Task (accuracy and reaction time).

Secondary Outcome Measures

Name	Time	Method
Glycemic response	Change from baseline (measured at 0-minutes before treatment) and 15-minutes, 30-minutes, 45-minutes, 60-minutes, 75-minutes, 90-minutes, 105-minutes and 120-minutes post-treatment consumption	Blood glucose (mmol/L). Blood glucose concentrations will be measured using a Freestyle Libre 2 continuous glucose monitoring (CGM) and flash-glucose system.
Subjective mood and emotion	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption	A visual analogue scale (VAS) with thirteen questions will be administered to assess subjective emotions and mood (aggression, anger, excitement, disappointment, happiness, upset, frustration, alertness, sadness, tension, exhaustion, calmness, sleepiness, and wellness). Individual questions will be used to form a composite emotion score. Each VAS will be administered via a digital software application (Express VAS, Toronto, Ontario, Canada) on a Dell tablet where children will place an 'X" on the VAS line (100 unit scale) to describe their feelings.

Trial Locations

Locations (1)

Centre for Urban Innovation (CUI-109), Toronto Metropolitan University (Formerly Ryerson University); 🇨🇦 Toronto, Ontario, Canada