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出境医 / 临床实验 / Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?

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

Study Description
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
Layout table for study information
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
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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
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

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Martin Binks, PhD Texas Tech University- Department of Nutritional Sciences
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?
Official Title  ICMJE Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Adolescents With Food Insecurity
Intervention  ICMJE
  • 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.
  • Other: Typical diet
    Subjects will be instructed to maintain their current dietary patterns.
Study Arms  ICMJE
  • Active Comparator: Typical Diet (TD)
    Participants will be instructed to continue habitual dietary intake.
    Intervention: Other: Typical diet
  • Experimental: Increased Egg Consumption (IE)
    Participants will be prescribed an additional 2 eggs per day to their diet.
    Intervention: Other: Increased Egg Consumption
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 30, 2021) 		18
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2019) 		14
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951883
Other Study ID Numbers  ICMJE TTUIRB2019-160
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin Binks, Texas Tech University
Study Sponsor  ICMJE Texas Tech University
Collaborators  ICMJE American Egg Board
Investigators  ICMJE
Principal Investigator: Martin Binks, PhD Texas Tech University- Department of Nutritional Sciences
PRS Account Texas Tech University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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