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_SUPPLEMENTIntervention 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: AvocadoParticipants will be provided avocados and asked to consume an avocado a day for 12 weeks.
- No Intervention: No AvocadoComparison 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
- Carol L Cheatham, Ph.D.704-250-5010
- Study Coordinator704-250-5018
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nutrition Research Institute | Kannapolis | North Carolina | 28081 |
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