NCT03838536 Synergistic Activity of Human Milk Nutrients and Infant Cognition
| NCT ID | NCT03838536 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Breastfeeding, Exclusive |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2019-02-05 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2019-02-05 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * infant with diagnosis or documented suspicion of developmental delay * egg allergy or family history of egg allergy * gestational diabetes * any documented seizure activity
Contact & Investigator
Carol L Cheatham, Ph.D.
PRINCIPAL INVESTIGATOR
Associate Professor, University of North Carolina-Chapel Hill
Frequently Asked Questions
Who can join the NCT03838536 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 35 Years, studying Breastfeeding, Exclusive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03838536 currently recruiting?
Yes, NCT03838536 is actively recruiting participants. Contact the research team at carol_cheatham@unc.edu for enrollment information.
Where is the NCT03838536 trial being conducted?
This trial is being conducted at Kannapolis, United States.
Who is sponsoring the NCT03838536 clinical trial?
NCT03838536 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Carol L Cheatham, Ph.D. at Associate Professor, University of North Carolina-Chapel Hill. The trial plans to enroll 84 participants.