NCT07583186

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Jan 2026Jun 2028

Study Start

First participant enrolled

January 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 13, 2026

Status Verified

October 1, 2025

Enrollment Period

2.4 years

First QC Date

April 30, 2026

Last Update Submit

May 6, 2026

Conditions

Pregnancy Related

Keywords

PregnancyPrenatal NutritionNeurodevelopment

Outcome Measures

Primary Outcomes (1)

  • Fetal neurodevelopment as indexed by heart rate variability (HRV)

    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

Secondary Outcomes (3)

  • Fetal neurodevelopment as indexed by heart rate variability (HRV)

    36 weeks gestational age

  • Infant neurodevelopment as indexed by event-related potentials (ERP)

    1 month postnatal age

  • Infant neurodevelopment as indexed by event-related potentials (ERP)

    1 month postnatal age

Study Arms (2)

EGG Group

EXPERIMENTAL

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.

Dietary Supplement: Egg Supplementation

HPD Group

PLACEBO COMPARATOR

The HPD group will receive education on a healthy prenatal diet

Dietary Supplement: Healthy Prenatal Diet

Interventions

Healthy Prenatal DietDIETARY_SUPPLEMENT

Educated on standard healthy prenatal diet and encouraged to follow recommendations.

HPD Group
Egg SupplementationDIETARY_SUPPLEMENT

Encouraged to consume 10-14 eggs per week.

EGG Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant females ≥18 years of age
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Study Officials

  • Danielle Christifano, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Mathis, MS

CONTACT

913-588-1906nmathis@kumc.edu

Lara Bennett, MS

CONTACT

913-945-9149lbennett@kumc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The Principal Investigator is blinded to participant intervention.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Dietetics and Nutrition

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 13, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 13, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)