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

9. november 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

18

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Lubbock, Texas, Forente stater, 79410
        • Nutrition & Metabolic Health Initiative
      • Lubbock, Texas, Forente stater, 79409
        • Texas Tech Neuroimaging Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år til 19 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Texas Tech University

Samarbeidspartnere

American Egg Board

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2019

Primær fullføring (Faktiske)

1. mars 2021

Studiet fullført (Faktiske)

1. mars 2021

Datoer for studieregistrering

Først innsendt

10. mai 2019

Først innsendt som oppfylte QC-kriteriene

14. mai 2019

Først lagt ut (Faktiske)

16. mai 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. november 2021

Sist bekreftet

1. november 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • TTUIRB2019-160

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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