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Recruiting Not applicable NCT03838536

Synergistic Activity of Human Milk Nutrients and Infant Cognition

No applicable phase (e.g. observational)
Conditions: Breastfeeding, Exclusive

Sponsor: University of North Carolina, Chapel Hill

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Whole Egg Powder
DIETARY_SUPPLEMENT
Egg White Powder
DIETARY_SUPPLEMENT
Locations 1
United States (1)
Nutrition Research Institute
Kannapolis , North Carolina
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
3 Months
Maximum age
35 Years
Healthy volunteers
No
Start date
05.02.2019
Completion date
01.03.2027
Registry ID
NCT03838536
Source
clinicaltrials.gov
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