Daily Egg Consumption and Cognitive Function in Older Adults

NCT05460624 | Withdrawn

• 1 other identifier: 13618
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition

Outcome Measures

Primary Outcomes (2)

• Composite Memory

  Derived from the CNSVS verbal and visual memory test scores

  12-week

• Executive Function

  Derived from Shifting Attention Test (SAT) from CNSVS battery of tests

  12-week

Secondary Outcomes (7)

• Verbal memory

  12-week

• Visual memory

  12-week

• Processing speed

  12-week

• Reaction time

  12-week

• Simple Attention

  12-week

Other Outcomes (10)

• Dietary intakes

  12-week

• Physical performance

  12-week

• Serum total cholesterol

  12-week

Study Arms (2)

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.

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.

Other: Typical American-style breakfast excluding eggs

Interventions

Egg-containing breakfast 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.

Intervention group

Typical American-style breakfast excluding eggs 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.

Control group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Indiana University: lead
• American Egg Board: collaborator

Study Sites (1)

Indiana University-Bloomington

Bloomington, Indiana, 47401, United States

Location

Study Officials

• Andrew W Brown, PhD

  Indiana University, Bloomington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be conducted before randomization at baseline and by individuals blinded to the treatment assignments at follow-up. Data will be analyzed prior to unblinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: February 10, 2023
• Primary Completion: February 10, 2023
• Study Completion: February 10, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately
• Access Criteria: Publicly available to anyone for the purpose of reproducing and/or verifying published results.

Locations

US (1)