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

NCT03951883 | Completed

• 1 other identifier: TTUIRB2019-160
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Adolescents With Food Insecurity

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (2)

Typical Diet (TD)

ACTIVE COMPARATOR

Participants will be instructed to continue habitual dietary intake.

Other: Typical diet

Increased Egg Consumption (IE)

EXPERIMENTAL

Participants will be prescribed an additional 2 eggs per day to their diet.

Other: Increased Egg Consumption

Interventions

Increased Egg Consumption OTHER

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.

Increased Egg Consumption (IE)

Typical diet OTHER

Subjects will be instructed to maintain their current dietary patterns.

Typical Diet (TD)

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• aneurism clips
• any implanted medical devices (pacemaker, neurostimulator)
• known pregnancy
• shrapnel in body or any injury to eye involving metal

Sponsors & Collaborators

• Texas Tech University: lead
• American Egg Board: collaborator

Study Sites (2)

Texas Tech Neuroimaging Institute

Lubbock, Texas, 79409, United States

Location

Nutrition & Metabolic Health Initiative

Lubbock, Texas, 79410, United States

Location

Study Officials

• Martin Binks, PhD

  Texas Tech University- Department of Nutritional Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 16, 2019
• Study Start: May 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

US (2)