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NCT Number: NCT07231146

Interaction Between Dairy and Gut Hormone Response on Cognitive Performance in Children.

The purpose of this study is to investigate the short-term effects of milk and yogurt of varying fat and protein content on cognitive performance in healthy children aged 9 - 14 years; and to provide insight into mechanisms by which dairy consumption may affect cognitive performance through gastrointestinal (GI) hormone responses. The investigators hypothesize that the consumption of dairy products, specifically their protein and fat components, will improve cognitive performance via its interaction with the gut-brain axis in children. Furthermore, the investigators hypothesize that all milk and yogurt products will enhance cognitive performance over 120- mins compared to snack skipping through its interaction with GI hormones, with a greater effect in higher fat containing milk and yogurt products.

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Key information

Conditions

Children Healthy

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Metropolitan University

Toronto, Ontario, M5B 2K3, Canada

Location status: Recruiting

Location contact

Nick Bellissimo

CONTACT

[email protected]

416-979-5000 ext. 553103

About this study

A randomized within-subject repeated measures experiment will be used to study the effect of milk and yogurt of varying fat content on cognitive performance and its interaction with GI hormones in children (9-14 years). Participants will consume milk [Experiment A] and yogurt [Experiment B] test treatments, followed by measures of cognitive performance, blood glucose and GI hormone biomarkers over 120-min. In Experiment A and B, participants will consume, in a random order on separate mornings, one of four test treatments: (1) Full-fat, (2) Low-Fat, (3) No-fat, and (4) Snack-skipping test treatments. Cognitive domains (learning and memory, spatial working memory, attention, processing speed, and executive function), gastrointestinal hormone response, and subjective emotions will be assessed at baseline (0-min), and 30-, 60-, and 120-min following treatment consumption.

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 is defined as being between the 5th and 85th percentile for age and biological sex at birth according to the Centers for Disease Control growth reference 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, 0.4 g fat, 26 g carbohydrate, and 18 g protein. Treatments matched for calories (180 kcal).

Low-Fat Milk

Other

Low-free milk (346 mL, 2%, Lactantia PurFiltre) will provide 180 kcal, 6.9 g fat, 16.6 g carbohydrate, and 12.5 g protein. Treatments matched for calories (180 kcal).

Full-fat Milk

Other

Full-free milk (281 mL, 3.25%, Lactantia PurFiltre) will provide 180 kcal, 9.0 g fat, 13.5 g carbohydrate, and 10.1 g protein. Treatments matched for calories (180 kcal).

Snack skipping

Other

Snack skipping (no caloric contribution).

Fat-free yogurt

Other

Fat-free Yogurt (242.3 g, Oikos High Protein Vanilla; 0% MF) will provide 180 kcal, 0 g fat, 20.8 g carbohydrate, and 23.5 g protein. Treatments matched for calories (180 kcal).

Low-Fat Yogurt

Other

Low-fat Yogurt (210.0 g, Oikos Original 2% MF) will provide 180 kcal, 3.6 g fat, 21.6 g carbohydrate, and 15.6 g protein. Treatments matched for calories (180 kcal).

Full-Fat Yogurt

Other

Full-fat Yogurt (185.3 g, Oikos Extra Creamy Vanilla 9% MF) will provide 180 kcal, 15.9 g fat, 21.2 g carbohydrate, and 6.4 g protein. Treatments matched for calories (180 kcal).

Primary outcomes

  1. Learning and short-term memory

    Time frame: Immediate measured at 30-minutes post-treatment and delayed at 60- 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 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 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).

  4. Executive Function

    Time frame: Change from baseline (measured at 0-minutes before treatment) and at 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)

Secondary outcomes

  1. Subjective mood and emotion

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

    A visual analogue scale (VAS) with twelve questions will be administered to assess subjective emotions and mood (aggression, anger, excitement, disappointment, happiness, upset, frustration, alertness, sadness, tension, 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.

  2. Gastrointestinal Hormone Response

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

    Blood biomarkers will include glucose, insulin, active GLP- 1, and total GIP. Blood samples will be collected via a venous catheter inserted into the participants arm by a Registered Nurse

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Collaborators

  • Dairy Management Inc.
  • National Dairy Council

Registry information

Official study title

Interaction Between Milk and Yogurt and Gastrointestinal Hormone Response on Cognitive Performance in School-Aged Children

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Dec 9, 2025

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.

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