Clinical trial NCT05460624: Daily Egg Consumption and Cognitive Function in Older Adults
Official title: Daily Egg Consumption and Cognitive Function in Older Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cognition
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2022-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Composite Memory
timeFrame: 12-week
measure: Executive Function
timeFrame: 12-week
Secondary outcomes:
measure: Verbal memory
timeFrame: 12-week
measure: Visual memory
timeFrame: 12-week
measure: Processing speed
timeFrame: 12-week
measure: Reaction time
timeFrame: 12-week
measure: Simple Attention
timeFrame: 12-week
measure: Working memory
timeFrame: 12-week
measure: Sustained Attention
timeFrame: 12-week
Other outcomes:
measure: Dietary intakes
timeFrame: 12-week
measure: Physical performance
timeFrame: 12-week
measure: Serum total cholesterol
timeFrame: 12-week
measure: Serum LDL cholesterol
timeFrame: 12-week
measure: Serum HDL cholesterol
timeFrame: 12-week
measure: Serum total triglycerides
timeFrame: 12-week
measure: Blood Pressure
timeFrame: 12-week
measure: Heart rate
timeFrame: 12-week
measure: Skin carotenoids score
timeFrame: 12-week
measure: Body composition
timeFrame: 12-week
Locations:
city: Bloomington
country: United States
facility: Indiana University-Bloomington
state: Indiana
Study officials:
affiliation: Indiana University, Bloomington
name: Andrew W Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: