Skip to main content
OpenTrials
Completed

NCT Number: NCT05767983

Effect of Dairy on Cognitive Performance 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Children Healthy

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Urban Innovation (CUI-109), Toronto Metropolitan University (Formerly Ryerson University)

Toronto, Ontario, M5B 2K3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fat-free milk

Other

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).

Fat-free yogurt

Other

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).

Low-fat cheese

Other

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).

Fruit juice

Other

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).

Snack skipping

Other

Water control treatment (no caloric contribution). Matched for volume (500 mL) to fat-free milk treatment.

Primary outcomes

  1. Learning and short-term memory

    Time frame: 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).

  2. Spatial working memory

    Time frame: 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).

  3. Sustained attention

    Time frame: 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).

  4. Executive function

    Time frame: 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 outcomes

  1. Glycemic response

    Time frame: 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.

  2. Subjective mood and emotion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Collaborators

  • Dairy Management Inc.
  • National Dairy Council

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2023
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.