Breastfeeding, Exclusive
Conditions
Keywords
Breastfeeding, Eggs, Baby
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.
Interventions
DIETARY_SUPPLEMENTWhole Egg Powder
Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
DIETARY_SUPPLEMENTEgg White Powder
Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.
Sponsors
Egg Nutrition Center
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
The participants will be given a jar of egg powder without labeling and they will not be aware of which they receive (egg white or whole egg).
Intervention model description
Participants will be randomized to whole egg or egg white powder to consume throughout the study.
Eligibility
Sex/Gender
ALL
Age
3 Months to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recognition Memory in an Oddball Task | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bayley Scales of Infant Development (BSID) | 6 weeks (at 4.5 months of age) | BSID administered at 4.5 months |
Countries
United States
Contacts
Primary ContactCarol L Cheatham, PhD
Backup ContactStudy Coordinator
Outcome results
None listed