Synergistic Activity of Human Milk Nutrients and Infant Cognition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole Egg Powder, Egg White Powder.
- Who it may be relevant to
- Registry conditions: Breastfeeding, Exclusive. Basic parameters: 3 months — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study
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.
Interventions
- Dietary supplement Whole Egg Powder
Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months. - Dietary supplement Egg White Powder
Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.
Primary outcome measures
- Recognition Memory in an Oddball Task [Time frame: 13 weeks (at 6 months of age)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Nutrition Research Institute — Kannapolis
Identifiers
NCT: NCT03838536 · 18-2216