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

Not Applicable

Recruiting

• Conditions: Children; Healthy

• Registration Number: NCT07231146
• Lead Sponsor: Toronto Metropolitan University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-11
• Study Start: 2025-11-01
• Study First Submitted: 2025-11-13
• Study First Submitted QC: 2025-11-13
• Last Update Submitted: 2025-11-13
• Study First Posted: 2025-11-17
• Last Update Posted: 2025-11-17
• Primary Completion: 2027-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Learning and short-term memory	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).
Spatial working memory	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).
Sustained Attention	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).
Executive Function	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 Outcome Measures

Name	Time	Method
Subjective mood and emotion	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.
Gastrointestinal Hormone Response	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

Trial Locations

Locations (1)

Toronto Metropolitan University; 🇨🇦 Toronto, Ontario, Canada