Daily Egg Consumption and Cognitive Function in Older Adults

NCT ID: NCT05460624

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2023-02-10

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.

Conditions

Cognition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Egg-containing breakfast

Intervention Type: OTHER

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.

Control group

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.

Group Type: OTHER

Typical American-style breakfast excluding eggs

Intervention Type: OTHER

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.

Interventions

Egg-containing breakfast

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.

Intervention Type: OTHER

Typical American-style breakfast excluding eggs

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Egg Board

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Brown

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew W Brown, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University, Bloomington

Locations

Indiana University-Bloomington

Bloomington, Indiana, United States

Countries

United States

Other Identifiers

13618

Identifier Type: -

Identifier Source: org_study_id