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

Toronto Metropolitan University

Status: Enrolling

Conditions: Healthy; Children

Treatments: Other: Full-fat Milk; Other: Fat-Free Milk; Other: Full-Fat Yogurt; Other: Low-Fat Milk; Other: Low-Fat Yogurt; Other: Fat-Free Yogurt; Other: Snack Skipping

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07231146

REB 25-066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 9 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 7 patient groups

Fat-Free Milk Treatment

Experimental group

Description:

Test Treatment

Treatment:

Other: Fat-Free Milk

Low-Fat Milk Treatment

Experimental group

Description:

Test Treatment

Treatment:

Other: Low-Fat Milk

Full-Fat Milk Treatment

Experimental group

Description:

Test Treatment

Treatment:

Other: Full-fat Milk

Snack Skipping Treatment

Experimental group

Description:

Test Treatment

Treatment:

Other: Snack Skipping

Fat-Free Yogurt

Experimental group

Description:

Test Treatment

Treatment:

Other: Fat-Free Yogurt

Low-Fat Yogurt

Experimental group

Description:

Test Treatment

Treatment:

Other: Low-Fat Yogurt

Full-Fat Yogurt

Experimental group

Description:

Test Treatment

Treatment:

Other: Full-Fat Yogurt