- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06465888
Influence of Eggs on Cognitive Performance
Evaluating the Influence of Egg Nutrients on Visual Cognitive Performance in Older Adults: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
College Station, Texas, United States, 77843
- Gilchrist Building
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No-Egg Control Group
The No-Egg Control group will not eat eggs or foods with eggs being one of the primary components of the food for 30 days.
|
|
|
Active Comparator: Egg White Group
Participants will eat four egg whites/day for 30 days.
Participants will be given a specified number of Kieke eggs to last them until their next appointment.
They will be asked to eat no other eggs than whites from the eggs given to them and to return cartons with any leftover eggs.
|
Participants will eat four egg whites daily for the 4-week study
|
|
Active Comparator: Whole Egg Group
Participants will eat two whole eggs/day for 30 days.
Participants will be given a specified number of Kieke eggs to last them until their next appointment.
They will be asked to eat no other eggs than the eggs given to them and to return cartons with any leftover eggs.
|
Participants will eat two eggs daily for the 4-week study
|
|
Active Comparator: Whole Omega-3 Egg Group
Participants will eat two Christopher Farms whole omega-3 eggs/day for 30 days.
Participants will be given a specified number of Christopher Farm eggs that will last them until their next appointment.
They will be asked to eat no other eggs than the two from the eggs given to them and to return cartons with any leftover eggs.
|
Participants will eat two Christopher Farms omega-3 fortified eggs daily for the 4-week study.
|
|
Active Comparator: Egg Yolk Group
Participants will eat four egg yolks/day for 30 days.
Participants will be given a specified number of Kieke eggs to last them until their next appointment.
They will be asked to eat no other eggs than the yolks from the eggs given to them and to return cartons with any leftover eggs.
|
Participants will eat four egg yolks daily for the 4-week study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Through study completion which may take up to 2 years.
|
|
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.
|
15 cognitive sessions within 10 days over 2 week period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum Lipid Levels
Time Frame: Through study completion which may take up to 2 years.
|
Serum will be drawn and analyzed for lipoprotein subfractions
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Through study completion which may take up to 2 years.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven E. Riechman, PhD, Texas A&M University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2017-0379D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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