Breastfeeding, ExclusiveNCT03838536
Synergistic Activity of Human Milk Nutrients and Infant Cognition
A study testing Whole Egg Powder and Egg White Powder in people with Breastfeeding, Exclusive, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal. Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Read more about this study
- Who is it for?
- Ages 3 months to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive
- What is being tested?
- Whole Egg Powder and Egg White Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2019to Mar 2027
- 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 3 months to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- infant is 12-15 weeks of age at enrollment
- healthy, lactating mother age 18-35
- gave birth at >38 weeks gestation without remarkable incident
- consuming <=50% of the recommended amounts of 2 of the 3, DHA, choline, and lutein
Who cannot join
- infant with diagnosis or documented suspicion of developmental delay
- egg allergy or family history of egg allergy
- gestational diabetes
- any documented seizure activity
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
Nutrition Research Institute
Kannapolis, North Carolina, 28081
Carol L Cheatham, Ph.D.
About this study
Official title: Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study
Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal.
Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Initial diet intake will be screened using the NDSR. Participants will come to the lab 3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma will be collected from the mother, while saliva and plasma (heel stick) are collected from the infant. Diet data will be collected at each visit. The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 months and 6 months.
- Conditions
- Breastfeeding, Exclusive
- Being tested
- Whole Egg Powder, Egg White Powder
- Keywords
- Breastfeeding, Eggs, Baby
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Egg PowderDietary supplement
Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
Egg White PowderDietary supplement
Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Whole egg powder | Experimental | Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid. Receives: Dietary Supplement: Whole Egg Powder |
| Egg white powder | Placebo comparator | The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid). Receives: Dietary Supplement: Egg White Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recognition Memory in an Oddball Task
The difference in microvolts between the negative deflection to novel pictures and the negative deflection to familiar pictures at approximately 100-400ms after the pictures come on the screen will be measured in an event-related potentials (ERP) paradigm. The investigators hypothesize that the whole egg group will have better memory for the familiar pictures than the egg white group.
Measured: 13 weeks (at 6 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start5 Feb 2019
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to whole egg or egg white powder to consume throughout the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Nutrition Center
- Responsible party
- Sponsor
- Investigators
- Carol L Cheatham, Ph.D., Principal investigator, Associate Professor, University of North Carolina-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838536
- Sponsor's protocol ID
- 18-2216
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2019
- Last updated
- 20 Apr 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study
- ClinicalTrials.gov ID
- NCT03838536
- Acronym / sponsor ID
- 18-2216
- Conditions
- Breastfeeding, Exclusive
- Keywords
- Breastfeeding, Eggs, Baby
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Egg Nutrition Center
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Feb 2019 (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.
Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal.
Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Initial diet intake will be screened using the NDSR. Participants will come to the lab 3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma will be collected from the mother, while saliva and plasma (heel stick) are collected from the infant. Diet data will be collected at each visit. The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 months and 6 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to whole egg or egg white powder to consume throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Whole egg powder | Experimental | Dietary Supplement: Whole Egg PowderParticipants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid. |
| Egg white powder | Placebo comparator | Dietary Supplement: Egg White PowderThe participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid). |
Who may qualify
- Ages
- 3 months to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- infant is 12-15 weeks of age at enrollment
- healthy, lactating mother age 18-35
- gave birth at >38 weeks gestation without remarkable incident
- consuming <=50% of the recommended amounts of 2 of the 3, DHA, choline, and lutein
Key exclusion criteria (4 listed)
- infant with diagnosis or documented suspicion of developmental delay
- egg allergy or family history of egg allergy
- gestational diabetes
- any documented seizure activity
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 |
|---|---|---|
| Whole Egg PowderBreastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months. | Dietary supplement | Whole egg powder |
| Egg White PowderBreastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months. | Dietary supplement | Egg white powder |
Primary outcome
Recognition Memory in an Oddball Task
Time frame: 13 weeks (at 6 months of age)
The difference in microvolts between the negative deflection to novel pictures and the negative deflection to familiar pictures at approximately 100-400ms after the pictures come on the screen will be measured in an event-related potentials (ERP) paradigm. The investigators hypothesize that the whole egg group will have better memory for the familiar pictures than the egg white group.
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 20 Apr 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.
Carol L Cheatham, Ph.D. principal investigator
Associate Professor, University of North Carolina-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Egg Powder and Egg White Powder in people with Breastfeeding, Exclusive, run by University of North Carolina, Chapel Hill 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 4 inclusion and 4 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 20 Apr 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 Carol L Cheatham, PhD (704-250-5010, carol_cheatham@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognition Memory in an Oddball Task (time frame: 13 weeks (at 6 months of 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 20 Apr 2026.