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

T

Texas Tech University

Status

Completed

Conditions

Adolescents With Food Insecurity

Treatments

Other: Increased Egg Consumption
Other: Typical diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03951883
TTUIRB2019-160

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

13 to 19 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Typical Diet (TD)
Active Comparator group
Description:
Participants will be instructed to continue habitual dietary intake.
Treatment:
Other: Typical diet
Increased Egg Consumption (IE)
Experimental group
Description:
Participants will be prescribed an additional 2 eggs per day to their diet.
Treatment:
Other: Increased Egg Consumption

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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