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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Avocado

    Dietary supplement

    Intervention arm

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: AvocadoExperimental treatment 1 intervention
Group B: No AvocadoNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 12 (at 6 months of age)
2

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).

Time frame
Baseline, Week 12
3

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).

Time frame
Baseline, Week 12
4

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).

Time frame
Baseline, Week 12

Secondary outcomes

1

Bayley Scales of Infant Development (BSID)

Neurodevelopmental assessment scores are age dependent and based motor and behavioral abilities, often reported for normal or abnormal for age. Bayley Scales of Infant and Toddler Development, 3rd edition, (Bayley III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items, score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit.

Time frame
Week 6 (at 4.5 months of age)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

Avocado Nutrition Center

Collaborator