Clinical trial NCT03951883: Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?
Official title: Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescents With Food Insecurity
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2019-05-16
Enrollment: 18
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Comparison of functional activity during Eriksen-Flanker Task
timeFrame: Baseline (pre-intervention) and 12 weeks (post-intervention)
measure: Comparison of grey matter anatomical change
timeFrame: Baseline (pre-intervention) and 12 weeks (post-intervention)
measure: Comparison of white matter connectivity change
timeFrame: Baseline (pre-intervention) and 12 weeks (post-intervention)
measure: Comparison of cognitive battery performance change
timeFrame: Baseline (pre-intervention) and 12 weeks (post-intervention)
measure: Comparison of cognitive battery performance change
timeFrame: Baseline (pre-intervention) and 12 weeks (post-intervention)
measure: Comparison of cognitive battery performance change
timeFrame: Baseline (pre-intervention) and 12 weeks (post-intervention)
measure: Comparison of cognitive battery performance change
timeFrame: Baseline (pre-intervention) and 12 weeks (post-intervention)
measure: Comparison of Eriksen-Flanker Task performance change
timeFrame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech Neuroimaging Institute
state: Texas
city: Lubbock
country: United States
facility: Nutrition & Metabolic Health Initiative
state: Texas
Study officials:
affiliation: Texas Tech University- Department of Nutritional Sciences
name: Martin Binks, PhD
role: PRINCIPAL_INVESTIGATOR
References: