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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06465888
Other study ID # IRB2017-0379D
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 22, 2017
Est. completion date March 19, 2020

Study information

Verified date June 2024
Source Texas A&M University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date March 19, 2020
Est. primary completion date March 19, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
egg whites
Participants will eat four egg whites daily for the 4-week study
whole eggs
Participants will eat two eggs daily for the 4-week study
Omega-3 eggs
Participants will eat two Christopher Farms omega-3 fortified eggs daily for the 4-week study.
egg yolk
Participants will eat four egg yolks daily for the 4-week study

Locations

Country Name City State
United States Gilchrist Building College Station Texas

Sponsors (2)

Lead Sponsor Collaborator
Texas A&M University Egg Nutrition Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive performance Neurotracker 3-Dimensional software used to measure cognitive performance 15 cognitive sessions within 10 days over 2 week period
Primary Nutrient Intake (Lutein and Zeaxanthin) Serum will be drawn and analyzed for lutein and zeaxanthin content Through study completion which may take up to 2 years.
Secondary Serum Lipid Levels Serum will be drawn and analyzed for lipoprotein subfractions Through study completion which may take up to 2 years.
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