Clinical trial NCT05767983: Effect of Dairy on Cognitive Performance in Children
Official title: Effect of Dairy on Cognitive Performance, Subjective Appetite and Glycemic Response in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Healthy
Keywords: Cognitive performance
Appetite
Mood
Glycemic response
Emotions
Dairy consumption
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Dairy Management Inc.
name: National Dairy Council
First posted: 2023-03-14
Enrollment: 54
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed description: A randomized within-subject repeated measures experiment will be used to study the effects of dairy product consumption on cognitive performance, subjective mood and emotions, and blood glucose in healthy 9 - 14 year old children. Participants will consume, in a random order on separate mornings, one of the five treatments: (a) milk, (b) yogurt, (c) cheese, (d) fruit juice, or (e) snack skipping. Subjective mood/emotions and cognitive domains (learning and memory, spatial working memory, attention, processing speed, and executive function) will be assessed at baseline (0-min), and 15-, 30-, 60-, and 120-min following treatment consumption. Blood glucose measurements will be collected using the Freestyle Libre 2 continuous glucose monitoring system.

Eligibility criteria: Inclusion Criteria:

* 9 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.

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.

Primary outcomes:
measure: Learning and short-term memory
timeFrame: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption
measure: Spatial working memory
timeFrame: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption
measure: Sustained attention
timeFrame: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption
measure: Executive function
timeFrame: 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:
measure: Glycemic response
timeFrame: 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
measure: Subjective mood and emotion
timeFrame: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Urban Innovation (CUI-109), Toronto Metropolitan University (Formerly Ryerson University)
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Nick Bellissimo, PhD
role: PRINCIPAL_INVESTIGATOR
References: