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Clinical Trials/NCT05767983
NCT05767983CompletedNot Applicable

Effect of Dairy on Cognitive Performance, Subjective Appetite and Glycemic Response in Children

Toronto Metropolitan University1 site in 1 country54 target enrollmentStarted: October 18, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
54
Locations
1
Primary Endpoint
Learning and short-term memory

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
9 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Fat-free yogurt

Experimental

Treatment

Intervention: Fat-free yogurt (Other)

Low-fat cheese

Experimental

Treatment

Intervention: Low-fat cheese (Other)

Fruit juice

Experimental

Treatment

Intervention: Fruit juice (Other)

Snack skipping

Experimental

Treatment

Intervention: Snack skipping (Other)

Fat-free milk

Experimental

Treatment

Intervention: Fat-free milk (Other)

Outcomes

Primary Outcomes

Learning and short-term memory

Time Frame: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

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).

Sustained attention

Time Frame: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

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).

Spatial working memory

Time Frame: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

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).

Executive function

Time Frame: Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption

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).

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nick Bellissimo, PhD

Associate Professor

Toronto Metropolitan University

Study Sites (1)

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