Effect of Dairy on Cognitive Performance in Children

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767983
• Other study ID #: Temp ID
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2023
• Source: Ryerson University
• Contact: Nick Bellissimo, PhD
• Phone: 4169795000
• Email: nick.bellissimo[@]ryerson.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children
• Healthy

Intervention

Other:
• Fat-free milk
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
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
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
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).
• Snack skipping
Water control treatment (no caloric contribution). Matched for volume (500 mL) to fat-free milk treatment.

Locations

Country	Name	City	State
Canada	Centre for Urban Innovation (CUI-109), Toronto Metropolitan University (Formerly Ryerson University)	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ryerson University	Dairy Management Inc., National Dairy Council

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Glycemic response	Blood glucose (mmol/L). Blood glucose concentrations will be measured using a Freestyle Libre 2 continuous glucose monitoring (CGM) and flash-glucose system.	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
Secondary	Subjective mood and emotion	A visual analogue scale (VAS) with thirteen questions will be administered to assess subjective emotions and mood (aggression, anger, excitement, disappointment, happiness, upset, frustration, alertness, sadness, tension, exhaustion, calmness, sleepiness, and wellness). Individual questions will be used to form a composite emotion score. Each VAS will be administered via a digital software application (Express VAS, Toronto, Ontario, Canada) on a Dell tablet where children will place an 'X" on the VAS line (100 unit scale) to describe their feelings.	Change from baseline (measured at 0-minutes before treatment) and at 15-minutes, 30-minutes, 60-minutes and 120-minutes post-treatment consumption