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Maternal Intake of Eggs and Infant Neurodevelopment (MIND)

6. maj 2026 opdateret af: Danielle Christifano, PhD, University of Kansas Medical Center
The fetal brain requires DHA, choline, lutein, and zeaxanthin (L/Z) for development, dependent on maternal intake during pregnancy. However, many pregnant women do not meet daily requirements through diet or prenatal vitamins. Egg yolks are rich in choline, and women who consume eggs daily are more likely to meet the adequate intake of 450 mg/day. A recent study by Christifano et al. found that maternal egg and neuroprotective nutrient intake predicted neurodevelopment at 32 and 36 weeks of gestation. This study aims to determine if fetal neurodevelopment is enhanced among women who consume a prenatal diet emphasizing egg consumption (EGG) versus a healthy prenatal diet education control group (HPD). Women between 12-20 weeks' gestation will be randomized into EGG and HPD groups. The EGG group will receive education on the importance of prenatal choline and egg consumption and be encouraged to consume 10-14 eggs per week. The HPD group will receive education on a healthy prenatal diet. Both groups will be encouraged to take a DHA supplement, and dietary intake of choline, L/Z, and DHA will be collected. Fetal heart rate variability will be measured at 36 weeks gestation and infant EEGs will be conducted postnatally to examine brain function. Increasing prenatal egg consumption is both economical and feasible to boost prenatal choline intake, promote offspring neurodevelopment, and guide prenatal dietary recommendations.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Rekruttering
        • The University of Kansas Medical Center
        • Kontakt:
          • Nicole Mathis, MS
          • Telefonnummer: 913-588-1906
        • Kontakt:
          • Lara Bennett, MS
          • Telefonnummer: 913-945-9149
        • Ledende efterforsker:
          • Danielle Christifano, PhD
        • Underforsker:
          • Alexandra Brown, PhD
        • Underforsker:
          • Ke Liao, PhD

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Pregnant females ≥18 years of age
  • 12 to 20-weeks' gestation at enrollment
  • No serious illnesses likely to confound study outcomes
  • Consuming 3 eggs/week or less at enrollment and willing to increase consumption during the study
  • Singleton gestation
  • Available by telephone and text

Exclusion Criteria:

  • Less than 18 years at enrollment
  • Gestational age at enrollment <12 or >20 weeks
  • Any serious illness likely to confound study outcomes
  • Consuming more than 3 eggs per week at enrollment
  • Unable/unwilling to consume eggs until delivery or egg allergy
  • Expecting multiple infants
  • No access to telephone or text

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: EGG Group
The EGG group will receive education on the importance of prenatal choline and egg consumption and be encouraged to consume 10-14 eggs per week.
Kosttilskud: Egg Supplementation
Encouraged to consume 10-14 eggs per week.
Placebo komparator: HPD Group
The HPD group will receive education on a healthy prenatal diet
Kosttilskud: Healthy Prenatal Diet
Educated on standard healthy prenatal diet and encouraged to follow recommendations.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fetal neurodevelopment as indexed by heart rate variability (HRV)
Tidsramme: 36 weeks gestational age
Group comparisons will be made between time-domain metrics of fetal HRV (SDNN, RMSSD) between those in EEG vs. HPD groups using a dedicated fetal heart rate monitor.
36 weeks gestational age

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fetal neurodevelopment as indexed by heart rate variability (HRV)
Tidsramme: 36 weeks gestational age
Relationship between intake of maternal neuroprotective nutrients, including choline, docosahexaenoic acid (DHA), lutein and zeaxanthin (L/Z) as measured by the Diet History Questionnaire-III and offspring neurodevelopment at 36 weeks gestation (fetal HRV).
36 weeks gestational age
Infant neurodevelopment as indexed by event-related potentials (ERP)
Tidsramme: 1 month postnatal age
Brain neurophysiology will be measured at 1 month of age. Assessments of band-limited spectral power during resting-state will be assessed. Event-related potentials (ERP) to auditory stimuli will be recorded. Group comparisons will be made between measures of resting state spectral power and auditory ERP components.
1 month postnatal age
Infant neurodevelopment as indexed by event-related potentials (ERP)
Tidsramme: 1 month postnatal age
Relationship between intake of maternal neuroprotective nutrients, including choline, docosahexaenoic acid (DHA), lutein and zeaxanthin (L/Z) as measured by the Diet History Questionnaire-III and offspring neurodevelopment at 1 month postnatal age (infant ERP).
1 month postnatal age

Samarbejdspartnere og efterforskere

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

Sponsor

University of Kansas Medical Center

Efterforskere

  • Ledende efterforsker: Danielle Christifano, PhD, University of Kansas Medical Center

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. januar 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2026

Sidst verificeret

1. oktober 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STUDY00161320
  • Award 2025-67017-44743 (Andet bevillings-/finansieringsnummer: USDA)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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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