NCT06465888

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

June 13, 2024

Last Update Submit

September 23, 2025

Conditions

Keywords

luteinzeaxanthinmacular pigment optical density (MPOD)macular pigmenteggscognitioncognitive performance

Outcome Measures

Primary Outcomes (2)

  • Cognitive performance

    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

  • 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 Outcomes (1)

  • Serum Lipid Levels

    Through study completion which may take up to 2 years.

Study Arms (5)

No-Egg Control Group

NO INTERVENTION

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.

Egg White Group

ACTIVE COMPARATOR

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.

Other: egg whites

Whole Egg Group

ACTIVE COMPARATOR

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.

Other: whole eggs

Whole Omega-3 Egg Group

ACTIVE COMPARATOR

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.

Other: Omega-3 eggs

Egg Yolk Group

ACTIVE COMPARATOR

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.

Other: egg yolk

Interventions

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

Egg White Group

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

Whole Egg Group

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

Whole Omega-3 Egg Group

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

Egg Yolk Group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and post-menopausal women who are age 50 to 75 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gilchrist Building

College Station, Texas, 77843, United States

Location

MeSH Terms

Interventions

Egg WhiteEgg Yolk

Intervention Hierarchy (Ancestors)

EggsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Steven E. Riechman, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Brand name of eggs on cartons will be covered so participants will not know which eggs they were eating.
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 20, 2024

Study Start

August 22, 2017

Primary Completion

March 19, 2020

Study Completion

March 19, 2020

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations