NutritionNCT03321227
Effect of Eggs and Egg Components on Cognitive Performance and Appetite in School-aged Children
A study testing Snack skipping, Whole eggs and Egg whites in people with Nutrition and Cognitive Performance, run by Toronto Metropolitan University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Cognitive Performance, Appetite
- What is being tested?
- Snack skipping, Whole eggs and Egg whites
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 9 Apr 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Nutrition, Cognitive Performance, Appetite
- Being tested
- Snack skipping, Whole eggs, Egg whites, Egg yolks, Yogurt
- Keywords
- Children, Nutrition, Eggs, Cognitive performance, Glycemic response, Appetite, Emotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snack skippingOther
No snack provided
Whole eggsOther
2 whole large eggs scrambled, provided as a snack
Egg whitesOther
2 egg whites scrambled, provided as a snack
Egg yolksOther
2 egg yolks scrambled, provided as a snack
YogurtOther
A serving of full fat yogurt that is isocaloric to the 2 whole eggs
| Study group | Role | What they receive |
|---|---|---|
| Snack skipping | Experimental | No snack provided Receives: Other: Snack skipping |
| Whole eggs | Experimental | 2 whole large eggs as a snack Receives: Other: Whole eggs |
| Egg whites | Experimental | 2 egg whites as a snack Receives: Other: Egg whites |
| Egg yolks | Experimental | 2 egg yolks as a snack Receives: Other: Egg yolks |
| Yogurt | Active comparator | Full fat yogurt as a snack Receives: Other: Yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 15, 30, 60, and 90 minutes
Secondary outcomes (10)
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.
Measured: 0, 15, 30, 60, and 90 minutes
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.
Measured: 0, 15, 30, 60, and 90 minutes
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).
Measured: 0, 15, 30, 60, and 90 minutes
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).
Measured: 0, 15, 30, 60, and 90 minutes
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).
Measured: 0, 15, 30, 60, and 90 minutes
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).
Measured: 0, 15, 30, 60, and 90 minutes
Change from baseline glycemic response
Blood glucose will be measured in whole blood using YSI 2300 STAT PLUS (YSI Incorporated, Yellow Springs, OH)
Measured: 0, 15, 30, 60, and 90 minutes
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.
Measured: 0, 15, 30, 60, and 90 minutes
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.
Measured: 0, 15, 30, 60, and 90 minutes
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.
Measured: 0, 15, 30, 60, and 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start9 Apr 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nick Bellissimo, Toronto Metropolitan University
- Investigators
- Nick Bellissimo, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321227
- Sponsor's protocol ID
- Ryerson-REB-2017
- Status last verified
- Mar 2020
- First submitted
- 18 Oct 2017
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eggs and Egg Components on Cognitive Performance and Appetite in School-aged Children
- ClinicalTrials.gov ID
- NCT03321227
- Acronym / sponsor ID
- Ryerson-REB-2017
- Conditions
- Nutrition, Cognitive Performance, Appetite
- Keywords
- Children, Nutrition, Eggs, Cognitive performance, Glycemic response, Appetite, Emotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Snack skipping | Experimental | Other: Snack skippingNo snack provided |
| Whole eggs | Experimental | Other: Whole eggs2 whole large eggs as a snack |
| Egg whites | Experimental | Other: Egg whites2 egg whites as a snack |
| Egg yolks | Experimental | Other: Egg yolks2 egg yolks as a snack |
| Yogurt | Active comparator | Other: YogurtFull fat yogurt as a snack |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snack skippingNo snack provided | Other | Snack skipping |
| Whole eggs2 whole large eggs scrambled, provided as a snack | Other | Whole eggs |
| Egg whites2 egg whites scrambled, provided as a snack | Other | Egg whites |
| Egg yolks2 egg yolks scrambled, provided as a snack | Other | Egg yolks |
| YogurtA serving of full fat yogurt that is isocaloric to the 2 whole eggs | Other | Yogurt |
Primary outcome
Change in memory from baseline
Time frame: 15, 30, 60, and 90 minutes
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.
Change in spatial working memory from baseline
Time frame: 0, 15, 30, 60, and 90 minutes
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.
Change in attention from baseline
Time frame: 0, 15, 30, 60, and 90 minutes
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.
Change in executive function from baseline
Time frame: 0, 15, 30, 60, and 90 minutes
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.
10 secondary outcomes
Change from baseline mood
Time frame: 0, 15, 30, 60, and 90 minutes
Change from baseline subjective appetite
Time frame: 0, 15, 30, 60, and 90 minutes
Change from baseline cholecystokinin (CCK)
Time frame: 0, 15, 30, 60, and 90 minutes
Change from baseline dipeptidyl peptidase 4 (DPP4)
Time frame: 0, 15, 30, 60, and 90 minutes
Change from baseline glucagonlike peptide1 (GLP1)
Time frame: 0, 15, 30, 60, and 90 minutes
Change from baseline insulin
Time frame: 0, 15, 30, 60, and 90 minutes
Change from baseline glycemic response
Time frame: 0, 15, 30, 60, and 90 minutes
Change from baseline amino acids
Time frame: 0, 15, 30, 60, and 90 minutes
Change from baseline fatty acids
Time frame: 0, 15, 30, 60, and 90 minutes
Change from baseline choline
Time frame: 0, 15, 30, 60, and 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Bellissimo, PhD principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snack skipping, Whole eggs and Egg whites in people with Nutrition and Cognitive Performance, run by Toronto Metropolitan University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in memory from baseline (time frame: 15, 30, 60, and 90 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.