Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465888
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-06-13
Brief Title:
Influence of Eggs on Cognitive Performance
Sponsor:
Texas AM University
Organization:
Texas AM University
Study Overview
Official Title:
Evaluating the Influence of Egg Nutrients on Visual Cognitive Performance in Older Adults A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to evaluate the nutrients in eggs in healthy adults 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None