RECRUITING

Synergistic Activity of Human Milk Nutrients and Infant Cognition

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2019-02-05
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03838536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Months to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * infant is 12-15 weeks of age at enrollment
  2. * healthy, lactating mother age 18-35
  3. * gave birth at \>38 weeks gestation without remarkable incident
  4. * consuming \<=50% of the recommended amounts of 2 of the 3, DHA, choline, and lutein
  1. * infant with diagnosis or documented suspicion of developmental delay
  2. * egg allergy or family history of egg allergy
  3. * gestational diabetes
  4. * any documented seizure activity

Contacts and Locations

Study Contact

Carol L Cheatham, PhD
CONTACT
704-250-5010
carol_cheatham@unc.edu
Study Coordinator
CONTACT
704-250-5018
feedingbrains@unc.edu

Principal Investigator

Carol L Cheatham, Ph.D.
PRINCIPAL_INVESTIGATOR
Associate Professor, University of North Carolina-Chapel Hill

Study Locations (Sites)

Nutrition Research Institute
Kannapolis, North Carolina, 28081
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Carol L Cheatham, Ph.D., PRINCIPAL_INVESTIGATOR, Associate Professor, University of North Carolina-Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-05
Study Completion Date2025-03

Study Record Updates

Study Start Date2019-02-05
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Breastfeeding
  • Eggs
  • Baby

Additional Relevant MeSH Terms

  • Breastfeeding, Exclusive