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Recruiting NCT07583186

Maternal Intake of Eggs and Infant Neurodevelopment

No phase Interventional Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Egg Supplementation, Healthy Prenatal Diet.
Who it may be relevant to
Registry conditions: Pregnancy Related. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Dietary supplement Egg Supplementation
    Encouraged to consume 10-14 eggs per week.
  • Dietary supplement Healthy Prenatal Diet
    Educated on standard healthy prenatal diet and encouraged to follow recommendations.

Primary outcome measures

  • Fetal neurodevelopment as indexed by heart rate variability (HRV) [Time frame: 36 weeks gestational age]
Secondary outcome measures (3)
  • Fetal neurodevelopment as indexed by heart rate variability (HRV) [Time frame: 36 weeks gestational age]
  • Infant neurodevelopment as indexed by event-related potentials (ERP) [Time frame: 1 month postnatal age]
  • Infant neurodevelopment as indexed by event-related potentials (ERP) [Time frame: 1 month postnatal age]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • The University of Kansas Medical Center — Kansas City

Identifiers

NCT: NCT07583186 · STUDY00161320 · Award 2025-67017-44743

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗