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Clinical Trials/NCT06465888
NCT06465888
Completed
Not Applicable

Evaluating the Influence of Egg Nutrients on Visual Cognitive Performance in Older Adults: A Randomized Controlled Trial

Texas A&M University1 site in 1 country106 target enrollmentAugust 22, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Function
Sponsor
Texas A&M University
Enrollment
106
Locations
1
Primary Endpoint
Cognitive performance
Status
Completed
Last Updated
7 months ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
August 22, 2017
End Date
March 19, 2020
Last Updated
7 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven E.Riechman, PhD, MPH

Associate Professor

Texas A&M University

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

Outcomes

Primary Outcomes

Cognitive performance

Time Frame: 15 cognitive sessions within 10 days over 2 week period

Neurotracker 3-Dimensional software used to measure cognitive performance. Subjects performed 20 trials within a single training session obtaining a "speed threshold," (ST) the level at which the participant correctly tracked and selected the correct objects 50% of the time. The final ST for each training session and the progression over 15 sessions were the primary determinants of cognitive performance.

Nutrient Intake (Lutein and Zeaxanthin)

Time Frame: Through study completion which may take up to 2 years.

Serum will be drawn and analyzed for lutein and zeaxanthin content

Secondary Outcomes

  • Serum Lipid Levels(Through study completion which may take up to 2 years.)

Study Sites (1)

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