Increased Egg Consumption
OtherSubjects 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.
Completed
NCT Number: NCT03951883
Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?
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.
Completed
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Notify MeKey information
Conditions
Age range
13 year–19 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Nutrition & Metabolic Health Initiative, Lubbock, Texas, United States
Loading trial locations.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
- aneurism clips
- any implanted medical devices (pacemaker, neurostimulator)
- known pregnancy
- shrapnel in body or any injury to eye involving metal
- any ferrous metal in body
Treatment and study plan
Typical diet
OtherSubjects will be instructed to maintain their current dietary patterns.
Primary outcomes
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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.
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Comparison of grey matter anatomical change
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Grey density as measured by MRI
-
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
-
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
-
Comparison of cognitive battery performance change
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Cognitive performance as measured by operation span task
-
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
-
Comparison of cognitive battery performance change
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Cognitive performance as measured by Boston Naming Task
-
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
Sponsors and collaborators
Lead sponsor
Texas Tech University
Other
Collaborators
- American Egg Board
Registry information
Important dates
- Study start
- 2019
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- May 16, 2019
- Registry last updated
- Nov 11, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.