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

NCT ID: NCT07231146

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2027-10-31

Brief Summary

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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

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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.

Conditions

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Children Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fat-Free Milk Treatment

Test Treatment

Group Type EXPERIMENTAL

Fat-Free Milk

Intervention Type 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 Treatment

Test Treatment

Group Type EXPERIMENTAL

Low-Fat Milk

Intervention Type 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 Treatment

Test Treatment

Group Type EXPERIMENTAL

Full-fat Milk

Intervention Type 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 Treatment

Test Treatment

Group Type EXPERIMENTAL

Snack Skipping

Intervention Type OTHER

Snack skipping (no caloric contribution).

Fat-Free Yogurt

Test Treatment

Group Type EXPERIMENTAL

Fat-Free Yogurt

Intervention Type 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

Test Treatment

Group Type EXPERIMENTAL

Low-Fat Yogurt

Intervention Type 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

Test Treatment

Group Type EXPERIMENTAL

Full-Fat Yogurt

Intervention Type 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).

Interventions

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Fat-Free Milk

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).

Intervention Type OTHER

Low-Fat Milk

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).

Intervention Type OTHER

Full-fat Milk

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).

Intervention Type OTHER

Snack Skipping

Snack skipping (no caloric contribution).

Intervention Type OTHER

Fat-Free Yogurt

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).

Intervention Type OTHER

Low-Fat Yogurt

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).

Intervention Type OTHER

Full-Fat Yogurt

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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dairy Management Inc.

INDUSTRY

Sponsor Role collaborator

Toronto Metropolitan University

OTHER

Sponsor Role lead

National Dairy Council

OTHER

Sponsor Role collaborator

Responsible Party

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Nick Bellissimo, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nick Bellissimo, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Metropolitan University

Locations

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Toronto Metropolitan University

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Nick Bellissimo

Role: primary

416-979-5000 ext. 553103

Other Identifiers

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REB 25-066

Identifier Type: -

Identifier Source: org_study_id

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