Effect of Eggs and Egg Components on Cognitive Performance and Appetite in School-aged Children

Nutrition Clinical Trial

Official title:

Effect of Eggs and Egg Components on Cognitive Performance and Appetite in School-aged Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321227
• Other study ID #: Ryerson-REB-2017
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2020
• Source: Ryerson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetite
• Cognitive Performance
• Nutrition

Intervention

Other:
• Snack skipping
No snack provided
• Whole eggs
2 whole large eggs scrambled, provided as a snack
• Egg whites
2 egg whites scrambled, provided as a snack
• Egg yolks
2 egg yolks scrambled, provided as a snack
• Yogurt
A serving of full fat yogurt that is isocaloric to the 2 whole eggs

Locations

Country	Name	City	State
Canada	School of Nutrition, Ryerson University	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ryerson University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change from baseline mood	Measured using visual analogue scale (mm). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings.These emotions will be seperated into three categories including, subjective emotions (aggressive, angry, excited, disappointed, and frustrated), global vigour and affect (alert, sad, tense, effort, happy, weary, calm and sleepy), and wellness. These sub scales will be combined to compute an average total score for each category.	0, 15, 30, 60, and 90 minutes
Secondary	Change from baseline subjective appetite	Measured using visual analogue scale (mm). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings. Average appetite will combine four questions (desire to eat, hunger, fullness, and prospective food consumption) to calculate the score.	0, 15, 30, 60, and 90 minutes
Secondary	Change from baseline cholecystokinin (CCK)	Blood CCK (pmol/L). CCK concentration in serum will be determined in duplicate via enzymelinked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).	0, 15, 30, 60, and 90 minutes
Secondary	Change from baseline dipeptidyl peptidase 4 (DPP4)	Blood DPP4 (ng/mL). DPP4 concentration in serum will be determined in duplicate via enzymelinked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).	0, 15, 30, 60, and 90 minutes
Secondary	Change from baseline glucagonlike peptide1 (GLP1)	Blood GLP1 (pmol/L). GLP1 concentration in serum will be determined in duplicate via enzymelinked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).	0, 15, 30, 60, and 90 minutes
Secondary	Change from baseline insulin	Blood insulin (pmol/L). Insulin concentration in serum will be determined in duplicate via enzymelinked immunosorbent assay kits (ELISA; Millipore, Billerica, Massachusetts).	0, 15, 30, 60, and 90 minutes
Secondary	Change from baseline glycemic response	Blood glucose will be measured in whole blood using YSI 2300 STAT PLUS (YSI Incorporated, Yellow Springs, OH)	0, 15, 30, 60, and 90 minutes
Secondary	Change from baseline amino acids	From plasma blood samples. Amino acids will be determined using the pre-column derivatization HPLC procedure. A plasma sample will be de-proteinizied with a 5-sulfosalicyclic acid solution, then centrifuged at 4°C and 18,400 G for 15 minutes. The amino acids will be derivatized from the sample with ortho-phthaldehyde reagent. The sample will then be analyzed using the Perkin Elmer Series HPLC System in the Ryerson University Analytical Centre.	0, 15, 30, 60, and 90 minutes
Secondary	Change from baseline fatty acids	From plasma blood samples. Fatty acids will be assessed via gas chromatography, an effective method to measure both the proportions and concentrations of fatty acids in plasma. A plasma sample will be prepared by trans-esterification of total lipid aliquots with a MeOH/HCl mixture and n-hexane. The sample will then be analyzed using the Perkin Elmer Auto-System in the Ryerson University Analytical Centre.	0, 15, 30, 60, and 90 minutes
Secondary	Change from baseline choline	From plasma blood samples. Will be analyzed for choline using a fluorimetric assay; free choline will be oxidized by choline oxidase to betaine and H2O2 that reacts with a specific dye to form a pink colored product. The fluorescence intensity at 530/585 nm is directly proportional to the choline concentration in the sample.	0, 15, 30, 60, and 90 minutes