- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07583186
Maternal Intake of Eggs and Infant Neurodevelopment (MIND)
May 6, 2026 updated by: 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicole Mathis, MS
- Phone Number: 913-588-1906
- Email: nmathis@kumc.edu
Study Contact Backup
- Name: Lara Bennett, MS
- Phone Number: 913-945-9149
- Email: lbennett@kumc.edu
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- The University of Kansas Medical Center
-
Contact:
- Nicole Mathis, MS
- Phone Number: 913-588-1906
-
Contact:
- Lara Bennett, MS
- Phone Number: 913-945-9149
-
Principal Investigator:
- Danielle Christifano, PhD
-
Sub-Investigator:
- Alexandra Brown, PhD
-
Sub-Investigator:
- Ke Liao, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Encouraged to consume 10-14 eggs per week.
|
|
Placebo Comparator: HPD Group
The HPD group will receive education on a healthy prenatal diet
|
Educated on standard healthy prenatal diet and encouraged to follow recommendations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fetal neurodevelopment as indexed by heart rate variability (HRV)
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fetal neurodevelopment as indexed by heart rate variability (HRV)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Danielle Christifano, PhD, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
April 30, 2026
First Submitted That Met QC Criteria
May 6, 2026
First Posted (Actual)
May 13, 2026
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 6, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00161320
- Award 2025-67017-44743 (Other Grant/Funding Number: USDA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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