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ChildrenNCT05767983

Effect of Dairy on Cognitive Performance in Children

A study testing Fat-free milk, Fat-free yogurt and Low-fat cheese in people with Children and Healthy, run by Toronto Metropolitan University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Children, Healthy
What is being tested?
Fat-free milk, Fat-free yogurt and Low-fat cheese
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteCanada
Study dates
18 Oct 2022to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Toronto, Ontario, M5B 2K3

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Children, Healthy
Being tested
Fat-free milk, Fat-free yogurt, Low-fat cheese, Fruit juice, Snack skipping
Keywords
Cognitive performance, Appetite, Mood, Glycemic response, Emotions, Dairy consumption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fat-free milkOther

    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 yogurtOther

    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 cheeseOther

    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 juiceOther

    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 skippingOther

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

Study groups in NCT05767983
Study groupRoleWhat they receive
Fat-free milkExperimentalTreatment
Receives: Other: Fat-free milk
Fat-free yogurtExperimentalTreatment
Receives: Other: Fat-free yogurt
Low-fat cheeseExperimentalTreatment
Receives: Other: Low-fat cheese
Fruit juiceExperimentalTreatment
Receives: Other: Fruit juice
Snack skippingExperimentalTreatment
Receives: Other: Snack skipping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

  2. 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).

    Measured: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

  3. 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).

    Measured: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

  4. 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).

    Measured: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

Secondary outcomes (2)

  1. 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.

    Measured: 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

  2. 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.

    Measured: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2023
  2. Study start18 Oct 2022
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05767983
Sponsor's protocol ID
Temp ID
Status last verified
Jul 2024
First submitted
23 Nov 2022
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wurtele M, Kucab M, Robayo S, Walker S, Arroyo A, Birkdar Z, Bellissimo N. Effect of dairy form on cognitive performance, glycemic response, and subjective emotions in children aged 9-14 years. Appl Physiol Nutr Metab. 2026 Jan 1;51:1-14. doi: 10.1139/apnm-2025-0329.

    PubMed 41825058

Questions about this trial

What is this clinical trial studying?

A study testing Fat-free milk, Fat-free yogurt and Low-fat cheese in people with Children and Healthy, run by Toronto Metropolitan University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05767983, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.

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