NCT03321227

Brief Summary

The purpose of the present study is to determine the effects of eggs and egg components on cognitive performance and appetite in children aged 9-14 years, as well as to identify the underlying physiological mechanisms in this relationship.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

October 18, 2017

Last Update Submit

March 9, 2020

Conditions

Keywords

ChildrenNutritionEggsCognitive performanceGlycemic responseAppetiteEmotion

Outcome Measures

Primary Outcomes (4)

  • Change in memory from baseline

    One of five word lists composed of 15 words will be audio-visually presented to children. The majority of the words will be one syllable, and four words in each list will be two syllables long. The list will be presented at baseline and the children will be asked to recall as many words as possible at each time-point. The list will be presented for 2.5 minutes, and children will have 2 minutes for both immediate and delayed recall.

    15, 30, 60, and 90 minutes

  • Change in spatial working memory from baseline

    Assessed using a spatial pattern recognition test via the Membrain application. The test consists of a series of subtests where children will be presented a picture with patterns to study, and asked to identify a picture with the same pattern from a group of four images. This test will be at each time-point and takes approximately 1 minute to complete.

    0, 15, 30, 60, and 90 minutes

  • Change in attention from baseline

    The continuous performance task (CPT) will be completed via the Membrain application. During the CPT task, children will be given a sequence of two letters to identify; for example respond to the detection of the letter "X" only when it is preceded by the letter "A". This task will be at each time-point and will take 3 minutes total to complete.

    0, 15, 30, 60, and 90 minutes

  • Change in executive function from baseline

    The Stroop task will be completed via the Membrain application. Children will be presented with a list of words presented in colors that match the word (congruent, the word 'red' presented in red) or colors that do not match the word (incongruent, the word 'red' presented in blue). Children will be asked to identify the color of the word, not the word itself. The task is scored for the number of correct and incorrect colors identified, as well as total time to completion. This test will be at each time-point and will take 1 minute to complete.

    0, 15, 30, 60, and 90 minutes

Secondary Outcomes (10)

  • Change from baseline mood

    0, 15, 30, 60, and 90 minutes

  • Change from baseline subjective appetite

    0, 15, 30, 60, and 90 minutes

  • Change from baseline cholecystokinin (CCK)

    0, 15, 30, 60, and 90 minutes

  • Change from baseline dipeptidyl peptidase 4 (DPP4)

    0, 15, 30, 60, and 90 minutes

  • Change from baseline glucagonlike peptide1 (GLP1)

    0, 15, 30, 60, and 90 minutes

  • +5 more secondary outcomes

Study Arms (5)

Snack skipping

EXPERIMENTAL

No snack provided

Other: Snack skipping

Whole eggs

EXPERIMENTAL

2 whole large eggs as a snack

Other: Whole eggs

Egg whites

EXPERIMENTAL

2 egg whites as a snack

Other: Egg whites

Egg yolks

EXPERIMENTAL

2 egg yolks as a snack

Other: Egg yolks

Yogurt

ACTIVE COMPARATOR

Full fat yogurt as a snack

Other: Yogurt

Interventions

No snack provided

Snack skipping

2 whole large eggs scrambled, provided as a snack

Whole eggs

2 egg whites scrambled, provided as a snack

Egg whites

2 egg yolks scrambled, provided as a snack

Egg yolks
YogurtOTHER

A serving of full fat yogurt that is isocaloric to the 2 whole eggs

Yogurt

Eligibility Criteria

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

You may qualify if:

  • be between 9 and 14 years of age
  • be healthy, and have been born at term
  • healthy body weight (between the 5th and 85th BMI percentile for age and gender)

You may not qualify if:

  • children with food sensitivities or allergies to eggs, egg-products, dairy and wheat
  • children with any diagnosed learning, emotional, or behavioral disabilities
  • children on medications that may influence cognitive performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nutrition, Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

MeSH Terms

Interventions

Egg WhiteEgg YolkYogurt

Intervention Hierarchy (Ancestors)

EggsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCultured Milk ProductsMilkBeveragesFermented FoodsDairy Products

Study Officials

  • Nick Bellissimo, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: A random and within subject repeated measures experiment to study the effects of egg consumption on cognitive performance in children and the underlying physiological mechanisms in this relationship.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 25, 2017

Study Start

April 9, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations