NCT07231146

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Nov 2025Oct 2027

First Submitted

Initial submission to the registry

November 13, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

November 13, 2025

Last Update Submit

December 2, 2025

Conditions

HealthyChildren

Keywords

Cognitive PerformanceDairyGastrointestinal HormonesEmotionsMood

Outcome Measures

Primary Outcomes (4)

  • 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).

    Immediate measured at 30-minutes post-treatment and delayed at 60- and 120-minutes post-treatment consumption

  • 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).

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

  • 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).

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

  • 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)

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

Secondary Outcomes (2)

  • 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

  • Gastrointestinal Hormone Response

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

Study Arms (7)

Fat-Free Milk Treatment

EXPERIMENTAL

Test Treatment

Other: Fat-Free Milk

Low-Fat Milk Treatment

EXPERIMENTAL

Test Treatment

Other: Low-Fat Milk

Full-Fat Milk Treatment

EXPERIMENTAL

Test Treatment

Other: Full-fat Milk

Snack Skipping Treatment

EXPERIMENTAL

Test Treatment

Other: Snack Skipping

Fat-Free Yogurt

EXPERIMENTAL

Test Treatment

Other: Fat-Free Yogurt

Low-Fat Yogurt

EXPERIMENTAL

Test Treatment

Other: Low-Fat Yogurt

Full-Fat Yogurt

EXPERIMENTAL

Test Treatment

Other: Full-Fat Yogurt

Interventions

Full-fat MilkOTHER

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).

Full-Fat Milk Treatment
Fat-Free YogurtOTHER

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).

Fat-Free Yogurt
Low-Fat YogurtOTHER

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).

Low-Fat Yogurt
Full-Fat YogurtOTHER

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).

Full-Fat Yogurt
Low-Fat MilkOTHER

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).

Low-Fat Milk Treatment
Fat-Free MilkOTHER

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).

Fat-Free Milk Treatment
Snack SkippingOTHER

Snack skipping (no caloric contribution).

Snack Skipping Treatment

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Metropolitan University

Toronto, Ontario, M5B 2K3, Canada

RECRUITING

MeSH Terms

Interventions

Diet, Fat-Restricted

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Nick Bellissimo, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

November 15, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)