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.
