Influence of Eggs on Cognitive Performance

Not Applicable

Completed

• Conditions: Cognitive Function

• Registration Number: NCT06465888
• Lead Sponsor: Texas A&M University

Brief Summary

This clinical trial aims to evaluate the nutrients in eggs in healthy adult's cognitive performance. The main questions it aims to answer are:

* How do the nutrients in eggs impact visual cognitive performance (VCP) in generally healthy older individuals?

* Will omega-3 fatty acids in eggs improve VCP in generally healthy older individuals?

Participants will be randomly placed in one of five dietary treatment groups, including four egg whites, two whole regular eggs, two whole omega-3 fortified eggs, four egg yolks, and a no-egg control. Blood will be drawn at baseline. During the first two weeks, participants will eat assigned eggs, consume their usual diet other than the eggs, and keep five food logs. Cognitive performance testing will start on day 15 and be measured over a 10-day period using the Neurotracker (NT) 3-D program. Data on ancillary factors influencing outcomes will be collected, and food will be logged on each NT training day. Blood will be drawn at the end of the study and compared with baseline levels.

Detailed Description

Generally, healthy males or 2 years post-menopausal females between 50 and 75 years old will be recruited for this study. Potential subjects will communicate interest to researchers, and a standardized email with a consent form will be sent to persons of interest. Prospective participants will complete a preliminary questionnaire evaluating visual health and Mini Mental State Exam (MMSE) to confirm inclusion criteria met, a study ID will be assigned. subjects will be randomly placed in a control group or one of four intervention groups: four egg whites, two whole regular eggs, two whole omega-3 eggs, and four egg yolks. Eggs will be provided to subjects based on their treatment groups; egg distribution will occur on days 1 and 15. Fifteen days of food logs, five days during the first 14 days of the study, and ten days of food logs each day the subjects train on the Neurotracker software. Food logs will be analyzed using Nutribase software.

Two weeks after the commencement of the study (Day 15), cognitive performance testing will begin. This testing will be conducted over a 10-day period, consisting of 15 training sessions. The Neurotracker (NT) 3-D program will be used for these sessions. On each NT training day, a daily data questionnaire will be used to collect data on ancillary factors that may influence the outcomes of the study.

Blood will be drawn at baseline, on day 15, and at the end of the study. Average nutrient intake and dietary patterns, baseline plasma draws, rate of change, and maximal performance on the NT software will be examined.

Study Timeline

• Study Start: 2017-08-22
• Primary Completion: 2020-03-19
• Study Completion: 2020-03-19
• Status Verified: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Healthy men and post-menopausal women who are age 50 to 75 years

Exclusion Criteria

• Taking supplements with >6 mg L and/or >2 mg Z two months before the study
• Self-reported diagnosis of age-related macular degeneration, diabetic retinopathy, glaucoma, or other eye conditions that may negatively impact visual cognitive performance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Cognitive performance	15 cognitive sessions within 10 days over 2 week period	Neurotracker 3-Dimensional software used to measure cognitive performance
Nutrient Intake (Lutein and Zeaxanthin)	Through study completion which may take up to 2 years.	Serum will be drawn and analyzed for lutein and zeaxanthin content

Secondary Outcome Measures

Name	Time	Method
Serum Lipid Levels	Through study completion which may take up to 2 years.	Serum will be drawn and analyzed for lipoprotein subfractions

Trial Locations

Locations (1)

Gilchrist Building; 🇺🇸 College Station, Texas, United States