Effect of Eggs and Egg Components on Cognitive Performance and Appetite in School-aged Children
1 other identifier
interventional
19
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
1 active site
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
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedStudy Start
First participant enrolled
April 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 11, 2020
March 1, 2020
8 months
October 18, 2017
March 9, 2020
Conditions
Keywords
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
EXPERIMENTALNo snack provided
Whole eggs
EXPERIMENTAL2 whole large eggs as a snack
Egg whites
EXPERIMENTAL2 egg whites as a snack
Egg yolks
EXPERIMENTAL2 egg yolks as a snack
Yogurt
ACTIVE COMPARATORFull fat yogurt as a snack
Interventions
Eligibility Criteria
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nick Bellissimo, PhD
Toronto Metropolitan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- 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