RECRUITING

Avocado Consumption, Nutrients in Human Milk, and Infant Cognitive Development

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

The goal of this interventional study is to establish a whole food, avocado, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. Eighty-eight breastfeeding dyads, 3m postnatal, will participate in this study designed to: 1. To document whether lactating mothers will comply in the consumption of 5 avocados a week for 12 weeks. 2. To ascertain the choline, lutein, and fatty acids present in human milk in women who eat avocado. 3. To measure the cognitive advantage conferred to infants whose mothers consume avocados while breastfeeding compared to a non-avocado-eating reference group. To this end, healthy, lactating women who are 13 weeks postpartum and their infants will be enrolled. Mothers will be provided avocados on a bi-weekly basis and will be asked to consume an avocado a day. Infant cognition will be tested when the infants are 4.5 and 6 months of age. Milk samples and diet data will be collected and assayed on a bi-weekly basis.

Official Title

An Avocado Intervention to Increase the Nutrients in Human Milk in Support of Infant Cognitive Development

Quick Facts

Study Start:2024-02-08
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06208085

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:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Carol L Cheatham, Ph.D.
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
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, 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 Date2024-02-08
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-02-08
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Breastfeeding
  • Avocados
  • Infant cognition

Additional Relevant MeSH Terms

  • Breastfeeding, Exclusive