Synergistic Activity of Human Milk Nutrients and Infant Cognition

Study Overview
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Brief Summary
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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.

Official Title
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Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study

Conditions
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Breastfeeding, Exclusive

Intervention / Treatment
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* Dietary Supplement: Whole Egg Powder
* Dietary Supplement: Egg White Powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to whole egg or egg white powder to consume throughout the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole egg powder<br>Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid. | Dietary Supplement: Whole Egg Powder<br>* Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.<br>|
| Placebo Comparator: Egg white powder<br>The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid). | Dietary Supplement: Egg White Powder<br>* Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 13 weeks (at 6 months of age) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Eggs, Baby