CognitionNCT05460624
Daily Egg Consumption and Cognitive Function in Older Adults
A study testing Egg-containing breakfast and Typical American-style breakfast excluding eggs in people with Cognition, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of provisioning twelve eggs weekly, incorporated into breakfast meals, on composite scores of executive functioning and memory using the CNSVS computerized test platform in older adults in a randomized study. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Egg-containing breakfast and Typical American-style breakfast excluding eggs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2023to 10 Feb 2023
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participant has autonomy over their food choices.
- Participant has the common appliances for storing refrigerated and frozen foods (i.e., refrigerator and freezer).
- Participant has common appliances to defrost/prepare foods (e.g., microwave oven, oven, stove, etc.).
- Participant has sufficient corrected visual acuity to read simple instructions on a computer/laptop screen
- Participant has a CNSVS standard (age-matched) score of 85-105 (inclusive) for either the domain composite memory (raw score is the sum of verbal memory score and visual memory score) or the domain executive function, and 80-110 for the other.
- Participant has no plans to change their routine (physical activity pattern, dietary habits, sleep pattern, smoking habits) during the study period unless advised as part of study participation.
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- Participant is willing to follow screening/assessment visit instructions.
- Participant is willing to consume the study foods as provided at the breakfast meals during the study period.
- Participant is willing and able to visit IUB campus on specified in-person visit days.
- Participant understands the study procedures and signs the informed consent to participate in the study and is willing to complete study procedures.
Who cannot join
- Participant is not fully vaccinated for COVID-19.
- Participant reports habitually consuming greater than 5.5 eggs per week.
- Participant has sensitivity, allergy, taste aversion, or other aversion (e.g., vegan) to any ingredient of the study food.
- Participant has substantial dietary restrictions (e.g., chronic kidney disease or familial hypercholesterolemia diet) that, based on the judgment of the Principal Investigator, would interfere with the intervention.
- Participant has an established diagnosis of or is under treatment for dementia or ADHD. Anxiety or depression are not exclusionary.
- Participant is under active chemotherapy treatment.
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- Participant is participating in a parallel research study that, based on the judgment of the Principal Investigator, would interfere with his or her ability to comply with the study protocol, or which might confound the interpretation of the study results.
- Participant is not able to read.
- Participant reports current use of cognitive enhancing medications, attention/concentration enhancing medications, anticonvulsant medications, and mood stabilizing medications.
- Participant has a condition that, based on the judgment of the Principal Investigator, would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University-Bloomington
Bloomington, Indiana, 47401
About this study
The purpose of this study is to test the effects of provisioning twelve eggs weekly, incorporated into breakfast meals, on composite scores of executive functioning and memory using the CNSVS computerized test platform in older adults in a randomized study.
Read the detailed description
Procedure: This study will test the effects of incorporating eggs at breakfast versus breakfasts that match a typical American breakfast on executive function and composite memory in adults 65 to 90 years old.
Randomization: Participants will be randomized using a permuted block randomization scheme to balance randomization across time with rolling enrollment, while ensuring allocation concealment through block sizes unknown to the investigators. Randomization will be also stratified by whether the individual participant is being randomized or multiple people from the same household (e.g., a couple being randomized together). This is to balance the number of randomized individual participants and households across the two conditions. Participants will be assigned sequentially
Analysis plan: An intention-to-treat analysis approach will be followed for data analysis. Primary statistical approach will be linear mixed models, including time, group, and their interaction as factors, where the interaction is the main test of interest to determine if the treatment group improved significantly more than the control group. The model will also include random effects for subjects (to account for repeated measurements) and for households (to adjust for clustering effect). Covariates for pre-randomization variables such as age, sex, education level, and computer familiarity may be included to account for variation in the outcomes and thereby improve power for the test of the intervention. For joint primary outcomes, we will split alpha of 0.05 between the two outcomes (p<0.025 for two-sided statistical significance). We will perform a compliers (threshold to be specified) and completers (those with both pre- and post-values) analysis as pre-specific secondary analyses on the primary outcomes. For pre-specified secondary outcomes, we will use the primary approach for the list of secondary outcomes. Results will be presented with and without multiple comparison or false discovery rate (FDR) corrections, and all analyzed outcomes will be reported.
- Conditions
- Cognition
- Being tested
- Egg-containing breakfast, Typical American-style breakfast excluding eggs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg-containing breakfastOther
Involves participants eating six premade egg-containing breakfast meals per week for 12 weeks. Each meal contains 2 eggs to provide 12 eggs per week.
Typical American-style breakfast excluding eggsOther
Involves participants eating six premade egg-excluding breakfast meals per week for 12 weeks. Breakfast meals are matched to the intervention egg-containing breakfast meals on total energy and saturated fat and to the 'What We Eat in America' on percent energy from macronutrients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants randomized to the intervention group will receive six premade egg-containing breakfast meals per week in the form of a 3-day rotating menu. Each meal contains 2 eggs to provide 12 eggs per week for a duration of 12 weeks. Receives: Other: Egg-containing breakfast |
| Control group | Other | Participants randomized to the control group will receive breakfast meals in the form of a 3-day rotating menu including typical foods found in American diets excluding eggs, e.g., corn flakes, milk, sausage, granola bars, fruit. Control recipes are matched to the intervention foods on total energy and saturated fat and to the 'What We Eat in America' on percent energy from macronutrients. Receives: Other: Typical American-style breakfast excluding eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Memory
Derived from the CNSVS verbal and visual memory test scores
Measured: 12-week
Executive Function
Derived from Shifting Attention Test (SAT) from CNSVS battery of tests
Measured: 12-week
Secondary outcomes (7)
Verbal memory
Derived from verbal memory test of CNSVS battery of tests
Measured: 12-week
Visual memory
Derived from visual memory test of CNSVS battery of tests
Measured: 12-week
Processing speed
Derived from symbol digit coding test of CNSVS battery of tests
Measured: 12-week
Reaction time
Derived from Stroop test of CNSVS battery of tests
Measured: 12-week
Simple Attention
Derived from continuous performance of CNSVS battery of tests
Measured: 12-week
Working memory
Derived from 4-Part continuous performance of CNSVS battery of tests
Measured: 12-week
Sustained Attention
Derived from 4-Part continuous performance of CNSVS battery of tests
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start10 Feb 2023
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Why it stopped: Study funding terminated prior to recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Andrew Brown, Indiana University
- Investigators
- Andrew W Brown, PhD, Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460624
- Sponsor's protocol ID
- 13618
- Status last verified
- Feb 2023
- First submitted
- 12 Jul 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified data and statistical code used for publication of the study results will be accessible publicly for other researchers to be able to reproduce and/or verify published results after confirmation that deidentified data cannot be reasonably statistically re-identified.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Egg Consumption and Cognitive Function in Older Adults
- ClinicalTrials.gov ID
- NCT05460624
- Acronym / sponsor ID
- 13618
- Conditions
- Cognition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study funding terminated prior to recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 15 Jul 2022 (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 this study is to test the effects of provisioning twelve eggs weekly, incorporated into breakfast meals, on composite scores of executive functioning and memory using the CNSVS computerized test platform in older adults in a randomized study.
Detailed description
Procedure: This study will test the effects of incorporating eggs at breakfast versus breakfasts that match a typical American breakfast on executive function and composite memory in adults 65 to 90 years old.
Randomization: Participants will be randomized using a permuted block randomization scheme to balance randomization across time with rolling enrollment, while ensuring allocation concealment through block sizes unknown to the investigators. Randomization will be also stratified by whether the individual participant is being randomized or multiple people from the same household (e.g., a couple being randomized together). This is to balance the number of randomized individual participants and households across the two conditions. Participants will be assigned sequentially
Analysis plan: An intention-to-treat analysis approach will be followed for data analysis. Primary statistical approach will be linear mixed models, including time, group, and their interaction as factors, where the interaction is the main test of interest to determine if the treatment group improved significantly more than the control group. The model will also include random effects for subjects (to account for repeated measurements) and for households (to adjust for clustering effect). Covariates for pre-randomization variables such as age, sex, education level, and computer familiarity may be included to account for variation in the outcomes and thereby improve power for the test of the intervention. For joint primary outcomes, we will split alpha of 0.05 between the two outcomes (p<0.025 for two-sided statistical significance). We will perform a compliers (threshold to be specified) and completers (those with both pre- and post-values) analysis as pre-specific secondary analyses on the primary outcomes. For pre-specified secondary outcomes, we will use the primary approach for the list of secondary outcomes. Results will be presented with and without multiple comparison or false discovery rate (FDR) corrections, and all analyzed outcomes will be reported.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Egg-containing breakfastParticipants randomized to the intervention group will receive six premade egg-containing breakfast meals per week in the form of a 3-day rotating menu. Each meal contains 2 eggs to provide 12 eggs per week for a duration of 12 weeks. |
| Control group | Other | Other: Typical American-style breakfast excluding eggsParticipants randomized to the control group will receive breakfast meals in the form of a 3-day rotating menu including typical foods found in American diets excluding eggs, e.g., corn flakes, milk, sausage, granola bars, fruit. Control recipes are matched to the intervention foods on total energy and saturated fat and to the 'What We Eat in America' on percent energy from macronutrients. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Participant has autonomy over their food choices.
- Participant has the common appliances for storing refrigerated and frozen foods (i.e., refrigerator and freezer).
- Participant has common appliances to defrost/prepare foods (e.g., microwave oven, oven, stove, etc.).
- Participant has sufficient corrected visual acuity to read simple instructions on a computer/laptop screen
- Participant has a CNSVS standard (age-matched) score of 85-105 (inclusive) for either the domain composite memory (raw score is the sum of verbal memory score and visual memory score) or the domain executive function, and 80-110 for the other.
Key exclusion criteria (10 listed)
- Participant is not fully vaccinated for COVID-19.
- Participant reports habitually consuming greater than 5.5 eggs per week.
- Participant has sensitivity, allergy, taste aversion, or other aversion (e.g., vegan) to any ingredient of the study food.
- Participant has substantial dietary restrictions (e.g., chronic kidney disease or familial hypercholesterolemia diet) that, based on the judgment of the Principal Investigator, would interfere with the intervention.
- Participant has an established diagnosis of or is under treatment for dementia or ADHD. Anxiety or depression are not exclusionary.
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 |
|---|---|---|
| Egg-containing breakfastInvolves participants eating six premade egg-containing breakfast meals per week for 12 weeks. Each meal contains 2 eggs to provide 12 eggs per week. | Other | Intervention group |
| Typical American-style breakfast excluding eggsInvolves participants eating six premade egg-excluding breakfast meals per week for 12 weeks. Breakfast meals are matched to the intervention egg-containing breakfast meals on total energy and saturated fat and to the 'What We Eat in America' on percent energy from macronutrients. | Other | Control group |
Primary outcome
Composite Memory
Time frame: 12-week
Derived from the CNSVS verbal and visual memory test scores
Executive Function
Time frame: 12-week
Derived from Shifting Attention Test (SAT) from CNSVS battery of tests
7 secondary outcomes
Verbal memory
Time frame: 12-week
Visual memory
Time frame: 12-week
Processing speed
Time frame: 12-week
Reaction time
Time frame: 12-week
Simple Attention
Time frame: 12-week
Working memory
Time frame: 12-week
Sustained Attention
Time frame: 12-week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: Yes. All deidentified data and statistical code used for publication of the study results will be accessible publicly for other researchers to be able to reproduce and/or verify published results after confirmation that deidentified data cannot be reasonably statistically re-identified.
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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.
Andrew W Brown, PhD principal investigator
Indiana University, Bloomington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg-containing breakfast and Typical American-style breakfast excluding eggs in people with Cognition, run by Indiana University at 1 site in United States.
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 10 inclusion and 10 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: withdrawn, as of the sponsor's last update on 28 Feb 2023. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Composite Memory (time frame: 12-week). The study lists 2 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 28 Feb 2023.