Maternal Intake of Eggs and Infant Neurodevelopment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Kansas Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Egg Supplementation

    Dietary supplement

    Encouraged to consume 10-14 eggs per week.

  • Healthy Prenatal Diet

    Dietary supplement

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: EGG GroupExperimental treatment 1 intervention
Group B: HPD GroupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
36 weeks gestational age

Secondary outcomes

1

Fetal neurodevelopment as indexed by heart rate variability (HRV)

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).

Time frame
36 weeks gestational age
2

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

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.

Time frame
1 month postnatal age
3

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

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).

Time frame
1 month postnatal age

Other outcomes

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