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

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ClinicalTrials.gov Identifier: NCT03951883
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : November 11, 2021
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Martin Binks, Texas Tech University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adolescents With Food Insecurity Other: Increased Egg Consumption Other: Typical diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : March 1, 2021
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of functional activity during Eriksen-Flanker Task [ Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention) ]
    Changes in regional brain activation during an fMRI scan.

  2. Comparison of grey matter anatomical change [ Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention) ]
    Grey density as measured by MRI

  3. Comparison of white matter connectivity change [ Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention) ]
    White matter connectivity as measured by diffusion tensor imaging

  4. Comparison of cognitive battery performance change [ Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention) ]
    Cognitive performance as measured by stop signal reaction time task

  5. Comparison of cognitive battery performance change [ Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention) ]
    Cognitive performance as measured by operation span task

  6. Comparison of cognitive battery performance change [ Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention) ]
    Cognitive performance as measured by Raven's Progressive Matrices

  7. Comparison of cognitive battery performance change [ Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention) ]
    Cognitive performance as measured by Boston Naming Task

  8. Comparison of Eriksen-Flanker Task performance change [ Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention) ]
    Eriksen-Flanker task performance compared using the drift diffusion model


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951883


Locations
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United States, Texas
Texas Tech Neuroimaging Institute
Lubbock, Texas, United States, 79409
Nutrition & Metabolic Health Initiative
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Texas Tech University
American Egg Board
Investigators
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Principal Investigator: Martin Binks, PhD Texas Tech University- Department of Nutritional Sciences
More Information
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Responsible Party: Martin Binks, Associate Professor, Texas Tech University
ClinicalTrials.gov Identifier: NCT03951883    
Other Study ID Numbers: TTUIRB2019-160
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No