Effect of Dairy on Cognitive Performance in Children
1 other identifier
interventional
54
1 country
1
Brief Summary
The purpose of this study is to determine the effects of dairy consumption on short-term cognitive performance, subjective mood and emotions, and glycemic response in healthy children aged 9 - 14 years. The investigators hypothesize that the consumption of dairy products as a mid-morning snack will improve mood and cognitive performance in children. Furthermore, the investigators hypothesize that all dairy products consumed as a mid-morning snack will imbue more benefits on mood and cognitive performance over 2-hours compared to fruit juice or snack skipping.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
1 active site
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 Start
First participant enrolled
October 18, 2022
CompletedFirst Submitted
Initial submission to the registry
November 23, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedJuly 18, 2024
July 1, 2024
1 year
November 23, 2022
July 17, 2024
Conditions
Keywords
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).
Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes 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 15-minutes, 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 and reaction time).
Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 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 and reaction time).
Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption
Secondary Outcomes (2)
Glycemic response
Change from baseline (measured at 0-minutes before treatment) and 15-minutes, 30-minutes, 45-minutes, 60-minutes, 75-minutes, 90-minutes, 105-minutes and 120-minutes post-treatment consumption
Subjective mood and emotion
Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption
Study Arms (5)
Fat-free milk
EXPERIMENTALTreatment
Fat-free yogurt
EXPERIMENTALTreatment
Low-fat cheese
EXPERIMENTALTreatment
Fruit juice
EXPERIMENTALTreatment
Snack skipping
EXPERIMENTALTreatment
Interventions
Fat-free milk (500 mL, skim, 0%, Lactantia PurFiltre) will provide 180 kcal, 0 g fat, 26 g carbohydrate, and 18 g protein. Treatments matched for calories (180 kcal).
Fat-free yogurt (242 g, vanilla, 0% Greek, Oikos) will provide 180 kcal, 0 g fat, 23.5 g carbohydrate, and 19.4 g protein. Treatments matched for calories (180 kcal).
Low-fat cheese (60 g, mild marble cheddar, 40% less fat, Selection) will provide 180 kcal, 10 g fat, 2 g carbohydrate, and 16 g protein. Treatments matched for calories (180 kcal).
Fruit juice (450 mL, Fruité® Fruit Punch) will provide 180 kcal, 0 g fat, 46.8 g carbohydrate, and 0 g protein. Treatments matched for calories (180 kcal).
Water control treatment (no caloric contribution). Matched for volume (500 mL) to fat-free milk treatment.
Eligibility Criteria
You may qualify if:
- to 14 years of age;
- Normal weight defined as between the 15th and 80th percentile for age and biological sex at birth according to the World Health Organization growth (WHO) 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
- Toronto Metropolitan Universitylead
- Dairy Management Inc.collaborator
- National Dairy Councilcollaborator
Study Sites (1)
Centre for Urban Innovation (CUI-109), Toronto Metropolitan University (Formerly Ryerson University)
Toronto, Ontario, M5B 2K3, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nick Bellissimo, PhD
Toronto Metropolitan University
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
- Associate Professor
Study Record Dates
First Submitted
November 23, 2022
First Posted
March 14, 2023
Study Start
October 18, 2022
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
July 18, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share