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

NCT ID: NCT03951883

Last Updated: 2021-11-11

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Adolescents With Food Insecurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Typical Diet (TD)

Participants will be instructed to continue habitual dietary intake.

Group Type ACTIVE_COMPARATOR

Typical diet

Intervention Type OTHER

Subjects will be instructed to maintain their current dietary patterns.

Increased Egg Consumption (IE)

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

Group Type EXPERIMENTAL

Increased Egg Consumption

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Typical diet

Subjects will be instructed to maintain their current dietary patterns.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Egg Board

OTHER

Sponsor Role collaborator

Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Martin Binks

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Binks, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University- Department of Nutritional Sciences

Locations

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Texas Tech Neuroimaging Institute

Lubbock, Texas, United States

Site Status

Nutrition & Metabolic Health Initiative

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TTUIRB2019-160

Identifier Type: -

Identifier Source: org_study_id