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

9. november 2021 opdateret af: Martin Binks, Texas Tech University
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Lubbock, Texas, Forenede Stater, 79410
        • Nutrition & Metabolic Health Initiative
      • Lubbock, Texas, Forenede Stater, 79409
        • Texas Tech Neuroimaging Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

13 år til 19 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Typical Diet (TD)
Participants will be instructed to continue habitual dietary intake.
Andet: Typical diet
Subjects will be instructed to maintain their current dietary patterns.
Eksperimentel: Increased Egg Consumption (IE)
Participants will be prescribed an additional 2 eggs per day to their diet.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of functional activity during Eriksen-Flanker Task
Tidsramme: Baseline (pre-intervention) and 12 weeks (post-intervention)
Changes in regional brain activation during an fMRI scan.
Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of grey matter anatomical change
Tidsramme: Baseline (pre-intervention) and 12 weeks (post-intervention)
Grey density as measured by MRI
Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of white matter connectivity change
Tidsramme: Baseline (pre-intervention) and 12 weeks (post-intervention)
White matter connectivity as measured by diffusion tensor imaging
Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change
Tidsramme: Baseline (pre-intervention) and 12 weeks (post-intervention)
Cognitive performance as measured by stop signal reaction time task
Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change
Tidsramme: Baseline (pre-intervention) and 12 weeks (post-intervention)
Cognitive performance as measured by operation span task
Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change
Tidsramme: Baseline (pre-intervention) and 12 weeks (post-intervention)
Cognitive performance as measured by Raven's Progressive Matrices
Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change
Tidsramme: Baseline (pre-intervention) and 12 weeks (post-intervention)
Cognitive performance as measured by Boston Naming Task
Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of Eriksen-Flanker Task performance change
Tidsramme: Baseline (pre-intervention) and 12 weeks (post-intervention)
Eriksen-Flanker task performance compared using the drift diffusion model
Baseline (pre-intervention) and 12 weeks (post-intervention)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Texas Tech University

Samarbejdspartnere

American Egg Board

Efterforskere

  • Ledende efterforsker: Martin Binks, PhD, Texas Tech University- Department of Nutritional Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2019

Primær færdiggørelse (Faktiske)

1. marts 2021

Studieafslutning (Faktiske)

1. marts 2021

Datoer for studieregistrering

Først indsendt

10. maj 2019

Først indsendt, der opfyldte QC-kriterier

14. maj 2019

Først opslået (Faktiske)

16. maj 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • TTUIRB2019-160

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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