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

Part of paid clinical trials in Kannapolis, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06208085
Status
Recruiting

Conditions

  • Breastfeeding, Exclusive

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Avocado — DIETARY_SUPPLEMENT
    Intervention arm

Study Details

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.

Key Dates

Start date
Feb 8, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

Recognition Memory in an Oddball Task [ Time Frame: Week 12 (at 6 months of age) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nutrition Research InstituteKannapolisNorth Carolina28081
Brandi Childers
704-250-5005

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