Effect of Dairy on Cognitive Performance in Children

Effect of Dairy on Cognitive Performance, Subjective Appetite and Glycemic Response in Children

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Children
• Intervention / Treatment: Other: Fat-free milk; Other: Fat-free yogurt; Other: Low-fat cheese; Other: Fruit juice; Other: 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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 2K3
      • Centre for Urban Innovation (CUI-109), Toronto Metropolitan University (Formerly Ryerson University)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fat-free milk; Treatment	Other: Fat-free milk; Fat-free milk (500 mL, skim, 0%, Lactantia PurFiltre) will provide 180 kcal, 0 g fat, 26 g carbohydrate, and 18 g protein. Treatments matched for calories (180 kcal).
Experimental: Fat-free yogurt; Treatment	Other: Fat-free yogurt; Fat-free yogurt (242 g, vanilla, 0% Greek, Oikos) will provide 180 kcal, 0 g fat, 23.5 g carbohydrate, and 19.4 g protein. Treatments matched for calories (180 kcal).
Experimental: Low-fat cheese; Treatment	Other: Low-fat cheese; Low-fat cheese (60 g, mild marble cheddar, 40% less fat, Selection) will provide 180 kcal, 10 g fat, 2 g carbohydrate, and 16 g protein. Treatments matched for calories (180 kcal).
Experimental: Fruit juice; Treatment	Other: Fruit juice; Fruit juice (450 mL, Fruité® Fruit Punch) will provide 180 kcal, 0 g fat, 46.8 g carbohydrate, and 0 g protein. Treatments matched for calories (180 kcal).
Experimental: Snack skipping; Treatment	Other: Snack skipping; Water control treatment (no caloric contribution). Matched for volume (500 mL) to fat-free milk treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Learning and short-term memory	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).	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption
Spatial working memory	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).	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption
Sustained attention	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).	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption
Executive function	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).	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic response	Blood glucose (mmol/L). Blood glucose concentrations will be measured using a Freestyle Libre 2 continuous glucose monitoring (CGM) and flash-glucose system.	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
Subjective mood and emotion	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.	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

Collaborators and Investigators

• Sponsor: Toronto Metropolitan University
• Collaborators: National Dairy Council; Dairy Management Inc.
• Investigators: Principal Investigator: Nick Bellissimo, PhD, Toronto Metropolitan University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Emotions; Cognitive performance; Mood; Appetite; Dairy consumption; Glycemic response
• Other Study ID Numbers: Temp ID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No