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

NCT06208085 | Recruiting

• 1 other identifier: 23-2933
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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. 1.To document whether lactating mothers will comply in the consumption of 5 avocados a week for 12 weeks.
2. 2.To ascertain the choline, lutein, and fatty acids present in human milk in women who eat avocado.
3. 3.To measure the cognitive advantage conferred to infants whose mothers consume avocados while breastfeeding compared to a non-avocado-eating reference group.

Conditions

Breastfeeding, Exclusive

Keywords

Breastfeeding; Avocados; Infant cognition

Outcome Measures

Primary Outcomes (4)

• 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 avocado group will have better memory for the familiar pictures than the no avocado group.

  Week 12 (at 6 months of age)

• Change in Choline Content of Milk

  Human milk will be assayed for choline every two weeks and analyzed for change over time (7 data points across 12 weeks).

  Baseline, Week 12

• Change in Lutein Content of Milk

  Human milk will be assayed for lutein every two weeks and analyzed for change over time (7 data points across 12 weeks).

  Baseline, Week 12

• Change in Fatty Acid Content of Milk

  Human milk will be assayed for fatty acids every two weeks and analyzed for change over time (7 data points across 12 weeks).

  Baseline, Week 12

Secondary Outcomes (1)

• Bayley Scales of Infant Development (BSID)

  Week 6 (at 4.5 months of age)

Study Arms (2)

Avocado

EXPERIMENTAL

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

Dietary Supplement: Avocado

No Avocado

NO INTERVENTION

Comparison arm in which no intervention occurs.

Interventions

Avocado DIETARY_SUPPLEMENT

Intervention arm

Avocado

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Avocado Nutrition Center: collaborator

Study Sites (1)

Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Carol L Cheatham, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol L Cheatham, Ph.D.

CONTACT

704-250-5010; carol_cheatham@unc.edu

Study Coordinator

CONTACT

704-250-5018; feedingbrains@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to avocado or no avocado groups. The avocado group will be asked to consume an avocado a day for 12 weeks.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: February 8, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data will be made available in University of North Carolina at Chapel Hill (UNC) Dataverse at the time of associated publication or end of the performance period, whichever comes first. Data will be stored and available in UNC Dataverse in perpetuity as indicated in UNC Dataverse preservation policies.
• Access Criteria: Interested researchers who email their interest will be granted access on a case-by-case basis after agreement between the funder and the PI, who co-own the data.

Locations

US (1)