Pregnancy RelatedMINDNCT07583186
Maternal Intake of Eggs and Infant Neurodevelopment
A study testing Egg Supplementation and Healthy Prenatal Diet in people with Pregnancy Related, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Egg Supplementation and Healthy Prenatal Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Nicole Mathis, MS, 913-588-1906
Lara Bennett, MS, 913-945-9149
About this study
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.
- Conditions
- Pregnancy Related
- Being tested
- Egg Supplementation, Healthy Prenatal Diet
- Keywords
- Pregnancy, Prenatal Nutrition, Neurodevelopment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg SupplementationDietary supplement
Encouraged to consume 10-14 eggs per week.
Healthy Prenatal DietDietary supplement
Educated on standard healthy prenatal diet and encouraged to follow recommendations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Egg Supplementation |
| HPD Group | Placebo comparator | The HPD group will receive education on a healthy prenatal diet Receives: Dietary Supplement: Healthy Prenatal Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 weeks gestational age
Secondary outcomes (3)
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).
Measured: 36 weeks gestational age
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.
Measured: 1 month postnatal age
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).
Measured: 1 month postnatal age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Christifano, PhD, University of Kansas Medical Center
- Investigators
- Danielle Christifano, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583186
- Sponsor's protocol ID
- STUDY00161320
- Other IDs
- Award 2025-67017-44743
- Acronym
- MIND
- Status last verified
- Oct 2025
- First submitted
- 30 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Intake of Eggs and Infant Neurodevelopment
- ClinicalTrials.gov ID
- NCT07583186
- Acronym / sponsor ID
- MIND / STUDY00161320
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Prenatal Nutrition, Neurodevelopment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGG Group | Experimental | Dietary Supplement: Egg SupplementationThe EGG group will receive education on the importance of prenatal choline and egg consumption and be encouraged to consume 10-14 eggs per week. |
| HPD Group | Placebo comparator | Dietary Supplement: Healthy Prenatal DietThe HPD group will receive education on a healthy prenatal diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg SupplementationEncouraged to consume 10-14 eggs per week. | Dietary supplement | EGG Group |
| Healthy Prenatal DietEducated on standard healthy prenatal diet and encouraged to follow recommendations. | Dietary supplement | HPD Group |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danielle Christifano, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg Supplementation and Healthy Prenatal Diet in people with Pregnancy Related, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Mathis, MS (913-588-1906, nmathis@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal neurodevelopment as indexed by heart rate variability (HRV) (time frame: 36 weeks gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.