NCT05767983

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 23, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

November 23, 2022

Last Update Submit

July 17, 2024

Conditions

Keywords

Cognitive performanceAppetiteMoodGlycemic responseEmotionsDairy consumption

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

EXPERIMENTAL

Treatment

Other: Fat-free milk

Fat-free yogurt

EXPERIMENTAL

Treatment

Other: Fat-free yogurt

Low-fat cheese

EXPERIMENTAL

Treatment

Other: Low-fat cheese

Fruit juice

EXPERIMENTAL

Treatment

Other: Fruit juice

Snack skipping

EXPERIMENTAL

Treatment

Other: Snack skipping

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 milk

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).

Fat-free yogurt

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).

Low-fat cheese

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).

Fruit juice

Water control treatment (no caloric contribution). Matched for volume (500 mL) to fat-free milk treatment.

Snack skipping

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Study Sites (1)

Centre for Urban Innovation (CUI-109), Toronto Metropolitan University (Formerly Ryerson University)

Toronto, Ontario, M5B 2K3, Canada

Location

MeSH Terms

Interventions

Fruit and Vegetable Juices

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Nick Bellissimo, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

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

Locations