Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06208085

Conditions

Breastfeeding, Exclusive

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Avocado

Study Details

Brief summary:

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.

Conditions

Breastfeeding, Exclusive

Study ID

NCT06208085

Start date

Feb 8, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria

  • Healthy lactating women at 13 weeks postpartum
  • Planning to exclusively breastfeed to 6 months of age
  • Gave birth at 38 weeks or greater gestation without remarkable incident
  • Pre-pregnancy BMI <30

Exclusion Criteria

  • Gestational diabetes
  • Infant with diagnosis or documented suspicion of developmental delay
  • Any documented seizure activity in infant
  • Family history of avocado, latex, or banana allergies

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Avocado

Participants will be provided avocados and asked to consume an avocado a day for 12 weeks.

no intervention: No Avocado

Comparison arm in which no intervention occurs.

Interventions

Avocado

Intervention arm

Primary outcome measure

  • Recognition Memory in an Oddball Task [ Time Frame: Week 12 (at 6 months of age) ]
  • Change in Choline Content of Milk [ Time Frame: Baseline, Week 12 ]
  • Change in Lutein Content of Milk [ Time Frame: Baseline, Week 12 ]
  • Change in Fatty Acid Content of Milk [ Time Frame: Baseline, Week 12 ]

Central Contacts and Locations

Central contacts

Carol L Cheatham, Ph.D.

704-250-5010carol_cheatham@unc.edu

Study Coordinator

704-250-5018feedingbrains@unc.edu

Locations

Nutrition Research Institute

Recruiting

Kannapolis, North Carolina, United States, 28081

Contacts

Brandi Childers

704-250-5005brandi_childers@unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Breastfeeding
  • Avocados
  • Infant cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-04-21.