Clinical trial NCT03321227: Effect of Eggs and Egg Components on Cognitive Performance and Appetite in School-aged Children
Official title: Effect of Eggs and Egg Components on Cognitive Performance and Appetite in School-aged Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition
Cognitive Performance
Appetite
Keywords: Children
Nutrition
Eggs
Cognitive performance
Glycemic response
Appetite
Emotion
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 19
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: Children will be asked to refrain from exercising the morning of their test day and inform researchers of any illness. Following a 12-hour overnight fast, children will consume a standardized breakfast of a cereal bar, fruit cup and orange juice at home (total 330 kcal). Children will be asked to avoid consumption of any other food, with the exception of water, until arrival at the laboratory 3 hours later.

At the laboratory, five treatments of: (a) 2 whole eggs, (b) 2 egg whites, (c) 2 egg yolks, (d) full fat yogurt isocaloric to the 2 whole eggs, and (e) snack skipping will be provided to children 9-14 years on separate days at least 7 days apart. Cognitive performance, subjective emotion/mood, and subjective appetite will be measured for 90-minutes following snack consumption (n=25). Cognitive performance assessments will include learning and memory, spatial memory, attention and processing speed, and executive functions. In a subgroup of individuals (n=10), glucose, insulin, incretin hormones (glucagon like peptide1(GLP1) and gastric inhibitory polypeptide (GIP)),dipeptidyl peptidase 4 (DPP4), amino acids, fatty acids, and choline will be measured for 90-minutes following snack consumption.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in memory from baseline
timeFrame: 15, 30, 60, and 90 minutes
measure: Change in spatial working memory from baseline
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change in attention from baseline
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change in executive function from baseline
timeFrame: 0, 15, 30, 60, and 90 minutes
Secondary outcomes:
measure: Change from baseline mood
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change from baseline subjective appetite
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change from baseline cholecystokinin (CCK)
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change from baseline dipeptidyl peptidase 4 (DPP4)
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change from baseline glucagonlike peptide1 (GLP1)
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change from baseline insulin
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change from baseline glycemic response
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change from baseline amino acids
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change from baseline fatty acids
timeFrame: 0, 15, 30, 60, and 90 minutes
measure: Change from baseline choline
timeFrame: 0, 15, 30, 60, and 90 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: School of Nutrition, Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Nick Bellissimo, PhD
role: PRINCIPAL_INVESTIGATOR
References: