Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?

Quality nutrient intake is essential for proper development and well-being of children in all aspects of health, including cognitive development. Eggs are of particular interest based on potential cognitive and neurological benefits due in part to significant concentrations of choline and lutein. While overall, choline and lutein have received considerable attention in the literature in relation to cognition and brain function, most studies involving intake in young adults have had short intervention periods ranging from 90 minutes to 3 days. Food insecurity has been associated with decreased academic performance. Given that populations with food insecurity have limited resources to direct towards nutrition, identifying how a widely available, highly versatile and largely affordable source of nutrients (i.e. eggs) may have favorable impacts on cognitive function and brain function will be valuable in informing public health recommendations in this at-risk population. As such the investigators will examine whether an increased egg consumption dietary prescription can have positive effects on functional activity (i.e. fMRI) during an Eriksen-Flanker task, anatomical changes in the brain (i.e. DTI, MRI), and cognitive abilities as measured by the Stop Signal Reaction Time task, Operation Span task, Raven's Progressive Matrices and the Boston Naming Task.

Study Overview

• Status: Completed
• Conditions: Adolescents With Food Insecurity
• Intervention / Treatment: Other: Typical diet; Other: Increased Egg Consumption

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79410
      • Nutrition & Metabolic Health Initiative
    • Lubbock, Texas, United States, 79409
      • Texas Tech Neuroimaging Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 13-19 years.
• Household has food security status of low or very low as designated by scoring 2-6 raw score using the U.S. Household Food Security Survey Module: Six-Item Short Form.

Exclusion Criteria:

• Participants unable or unwilling to provide informed consent.
• Participants with motor, visual or hearing impairment.
• Participants with current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression)
• Participants with history of psychiatric hospitalization.
• Participants with habitual egg consumption (past 3 months) of 4 eggs per week or more
• Unable or unwilling to consume required study meals for any reason (e.g. dietary restrictions, allergies, or aversions to any of the food items used in the study).
• History of liver or kidney disease, cardiovascular disease, hematologic disease, metabolic disease, Epilepsy (or other seizure disorder) or malignant tumor
• Currently taking (or have taken in the past 4 weeks) any anti-anxiolytic, anti-epileptic, or anti-depression medications
• Currently taking (or have taken in the past 4 weeks) any proton pump inhibitor medications
• History of any cognitive disorder, medical and/or psychological conditions and/or medications affecting cognition

• Participants with contraindications for MRI scanning.

  1. aneurism clips
  2. any implanted medical devices (pacemaker, neurostimulator)
  3. known pregnancy
  4. shrapnel in body or any injury to eye involving metal
  5. any ferrous metal in body

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Typical Diet (TD); Participants will be instructed to continue habitual dietary intake.	Other: Typical diet; Subjects will be instructed to maintain their current dietary patterns.
Experimental: Increased Egg Consumption (IE); Participants will be prescribed an additional 2 eggs per day to their diet.	Other: Increased Egg Consumption; Subjects will be instructed to use a weekly food purchase supplement for inclusion of 2 additional eggs per day to be added to subject's typical daily diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of functional activity during Eriksen-Flanker Task	Changes in regional brain activation during an fMRI scan.	Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of grey matter anatomical change	Grey density as measured by MRI	Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of white matter connectivity change	White matter connectivity as measured by diffusion tensor imaging	Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change	Cognitive performance as measured by stop signal reaction time task	Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change	Cognitive performance as measured by operation span task	Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change	Cognitive performance as measured by Raven's Progressive Matrices	Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change	Cognitive performance as measured by Boston Naming Task	Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of Eriksen-Flanker Task performance change	Eriksen-Flanker task performance compared using the drift diffusion model	Baseline (pre-intervention) and 12 weeks (post-intervention)

Collaborators and Investigators

• Sponsor: Texas Tech University
• Collaborators: American Egg Board
• Investigators: Principal Investigator: Martin Binks, PhD, Texas Tech University- Department of Nutritional Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TTUIRB2019-160

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No