Synergistic Activity of Human Milk Nutrients and Infant Cognition

University of North Carolina (UNC)

Status: Enrolling

Conditions: Breastfeeding, Exclusive

Treatments: Dietary Supplement: Egg White Powder; Dietary Supplement: Whole Egg Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT03838536

18-2216

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 3 months to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups, including a placebo group

Whole egg powder

Experimental group

Description:

Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.

Treatment:

Dietary Supplement: Whole Egg Powder

Egg white powder

Placebo Comparator group

Description:

The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid).

Treatment:

Dietary Supplement: Egg White Powder