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View on ClinicalTrials.gov

Comparing 7 approaches for children

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

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

Condition: ChildrenSponsor: Toronto Metropolitan UniversityTarget enrollment: 48
  • 7 groups
  • One site, in Toronto
  • Recruiting
Toronto Metropolitan University, Toronto, Ontario

Interventions (7)

  • Other intervention

    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).

  • Other intervention

    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).

  • Other intervention

    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).

Canadian Sites (1)

1 of 1 recruiting

  • Toronto Metropolitan University

    Toronto, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for6 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +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 ControlControl groupThe group a new treatment is measured against.Read more → growth reference charts

Exclusion

  • Children with food sensitivities or allergies to dairy, gluten or any foods used in the study;
  • Children with overweight/ obesity;
  • Children with any diagnosed learning, emotional, or behavioural disabilities;
  • Children taking any medications that may influence cognitive performance.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to prevent a condition from developing.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 7 groups in this study.

Group A receives Fat-Free Milk.

Registry label: A: Fat-Free Milk Treatment

Group B receives Low-Fat Milk.

Registry label: B: Low-Fat Milk Treatment

Group C receives Full-fat Milk.

Registry label: C: Full-Fat Milk Treatment

Group D receives Snack Skipping.

Registry label: D: Snack Skipping Treatment

Group E receives Fat-Free Yogurt.

Registry label: E: Fat-Free Yogurt

Group F receives Low-Fat Yogurt.

Registry label: F: Low-Fat Yogurt

Group G receives Full-Fat Yogurt.

Registry label: G: Full-Fat Yogurt

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 9 years to 14 years.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 48 people.

The study is currently expected to finish around October 2027.

The main measurement is taken over: Immediate measured at 30-minutes post-treatment and delayed at 60- and 120-minutes post-treatment consumption.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Learning and short-term memory — measured over Immediate measured at 30-minutes post-treatment and delayed at 60- and 120-minutes post-treatment consumption.

Spatial working memory — measured over Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption.

Sustained Attention — measured over Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption.

Executive Function — measured over Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07231146 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About 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).

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About 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).

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About 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).

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About Snack SkippingOther

Snack skipping (no caloric contribution).

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About 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).

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About 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).

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About 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).

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 9 years to 14 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 9 years to 14 years.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Immediate measured at 30-minutes post-treatment and delayed at 60- and 120-minutes post-treatment consumption.

The study as a whole is currently expected to finish around 2027-10.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 48 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Toronto, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.