Clinical trial NCT06465888: Influence of Eggs on Cognitive Performance
Official title: Evaluating the Influence of Egg Nutrients on Visual Cognitive Performance in Older Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Keywords: lutein
zeaxanthin
macular pigment optical density (MPOD)
macular pigment
eggs
cognition
cognitive performance
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Egg Nutrition Center
First posted: 2024-06-20
Enrollment: 106
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a 30-day study. Serum analysis and diagnostic testing will be conducted at baseline. Participants will be randomly assigned to a no-egg control or one of the following dietary treatment groups: 4 large egg whites daily; 2 large whole eggs daily; 2 large whole omega-3 fortified eggs daily; or 4 large egg yolks daily. Participants will be asked to follow their routine food and beverage intake other than the assigned dietary treatment guidelines. Fifteen food logs will be completed. The last two weeks will include 15 Neurotracker 3-D cognitive training sessions over 10 days with diagnostic measures, physical activity, and sleep patterns recorded. Serum blood draw at day 30.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive performance
timeFrame: 15 cognitive sessions within 10 days over 2 week period
measure: Nutrient Intake (Lutein and Zeaxanthin)
timeFrame: Through study completion which may take up to 2 years.
Secondary outcomes:
measure: Serum Lipid Levels
timeFrame: Through study completion which may take up to 2 years.
Other outcomes:
Locations:
city: College Station
country: United States
facility: Gilchrist Building
state: Texas
Study officials:
affiliation: Texas A&M University
name: Steven E. Riechman, PhD
role: PRINCIPAL_INVESTIGATOR
References: