Daily Egg Consumption and Cognitive Function in Older Adults

Cognition Clinical Trial

Official title:

Daily Egg Consumption and Cognitive Function in Older Adults

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05460624
• Other study ID #: 13618
• Status: Withdrawn
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: February 10, 2023

Study information

• Verified date: February 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Indiana University-Bloomington	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	American Egg Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary intakes	Measurement tool: 3-day food record	12-week
Other	Physical performance	Measurement tool: The Short Physical Performance Battery (SPPB)	12-week
Other	Serum total cholesterol		12-week
Other	Serum LDL cholesterol		12-week
Other	Serum HDL cholesterol		12-week
Other	Serum total triglycerides		12-week
Other	Blood Pressure		12-week
Other	Heart rate		12-week
Other	Skin carotenoids score	Measurement tool: The Vegie Meter®	12-week
Other	Body composition	Measurement tool: Dual-energy X-ray absorptiometry (DEXA)	12-week
Primary	Composite Memory	Derived from the CNSVS verbal and visual memory test scores	12-week
Primary	Executive Function	Derived from Shifting Attention Test (SAT) from CNSVS battery of tests	12-week
Secondary	Verbal memory	Derived from verbal memory test of CNSVS battery of tests	12-week
Secondary	Visual memory	Derived from visual memory test of CNSVS battery of tests	12-week
Secondary	Processing speed	Derived from symbol digit coding test of CNSVS battery of tests	12-week
Secondary	Reaction time	Derived from Stroop test of CNSVS battery of tests	12-week
Secondary	Simple Attention	Derived from continuous performance of CNSVS battery of tests	12-week
Secondary	Working memory	Derived from 4-Part continuous performance of CNSVS battery of tests	12-week
Secondary	Sustained Attention	Derived from 4-Part continuous performance of CNSVS battery of tests	12-week