Influence of Eggs on Cognitive Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-22

Study Completion Date

2020-03-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This is a 30-day study. Serum analysis and diagnostic testing will be conducted at baseline. Participants will be randomly assigned to a no-egg control or one of the following dietary treatment groups: 4 large egg whites daily; 2 large whole eggs daily; 2 large whole omega-3 fortified eggs daily; or 4 large egg yolks daily. Participants will be asked to follow their routine food and beverage intake other than the assigned dietary treatment guidelines. Fifteen food logs will be completed. The last two weeks will include 15 Neurotracker 3-D cognitive training sessions over 10 days with diagnostic measures, physical activity, and sleep patterns recorded. Serum blood draw at day 30.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Brand name of eggs on cartons will be covered so participants will not know which eggs they were eating.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

egg whites

Intervention Type OTHER

Participants will eat four egg whites daily for the 4-week study

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.

Group Type ACTIVE_COMPARATOR

whole eggs

Intervention Type OTHER

Participants will eat two eggs daily for the 4-week study

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.

Group Type ACTIVE_COMPARATOR

Omega-3 eggs

Intervention Type OTHER

Participants will eat two Christopher Farms omega-3 fortified eggs daily for the 4-week study.

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.

Group Type ACTIVE_COMPARATOR

egg yolk

Intervention Type OTHER

Participants will eat four egg yolks daily for the 4-week study

Interventions

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egg whites

Participants will eat four egg whites daily for the 4-week study

Intervention Type OTHER

whole eggs

Participants will eat two eggs daily for the 4-week study

Intervention Type OTHER

Omega-3 eggs

Participants will eat two Christopher Farms omega-3 fortified eggs daily for the 4-week study.

Intervention Type OTHER

egg yolk

Participants will eat four egg yolks daily for the 4-week study

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes