Breastfeeding, ExclusiveNCT06208085
Avocado Consumption, Nutrients in Human Milk, and Infant Cognitive Development
A study testing Avocado in people with Breastfeeding, Exclusive, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive
- What is being tested?
- Avocado
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nutrition Research Institute
Kannapolis, North Carolina, 28081
Brandi Childers, 704-250-5005, brandi_childers@unc.edu
About this study
Official title: An Avocado Intervention to Increase the Nutrients in Human Milk in Support of Infant Cognitive Development
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:
- To document whether lactating mothers will comply in the consumption of 5 avocados a week for 12 weeks.
- To ascertain the choline, lutein, and fatty acids present in human milk in women who eat avocado.
- 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.
Read the detailed description
Nutrients do not appear in nature alone with some appearing together more often than not. It is reasonable to posit that nutrients are working together, and thus, the synergies among the nutrients are important to understand. First, choline is integral to brain fatty acids in that phosphatidylcholine (PC) serves an active role in mediating hepatic export of fatty acids to extra-hepatic tissues such as brain: fatty acids are stored in the liver, and PC moves them to the brain. Erythrocyte PC-DHA is integral to our consideration of a potential mechanism behind our results. Enriched in docosahexaenoic acid (DHA), PC comprises the cell membrane and influences membrane fluidity with downstream effects on signal transduction thereby improving speed of processing and recognition memory. Lutein has a very important role also in that it is known to co-localize with DHA specifically resulting in improvements in visual acuity, for example, and in general, it has been shown to protect fatty acids from peroxidation. Indeed, interventions with avocado have shown a significant increase in plasma lutein and a decrease in lipid peroxidation. It is hypothesized that lutein is also having this effect in the brain. As work with single nutrient supplementation does not yield strong cognitive effects, the investigators study the effects of co-occurring nutrients on cognitive development. The proposed study is designed to achieve an overall objective of establishing a whole food, avocado, as a viable study material in the pursuit of optimization of human milk with nutrients that support brain development. The long-term goal is to establish guidelines for maternal nutrition during gestation and lactation that include key nutrients for fetal and infant brain development, and the overall impact of this research program will be to set children on a trajectory for school readiness. The central hypothesis is that maternal avocado consumption will provide nutrients through human milk to support the development and function of neural substrates that support cognition. Specifically, choline, lutein, and fatty acids will work synergistically to improve brain function.
Mothers will be randomized to avocado or no avocado (due to lack of an appropriate control food). Participants will come to the lab 3 times across 6 months (enrollment/3months, 4.5 months, and 6 months). Milk sample will be provided every two weeks and will be picked up from the participants. At pickup, the avocado group will also be provided a new supply of avocados. Diet data will be collected at each visit/pickup (every two weeks). The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 and 6 months. Saliva samples will also be collected.
- Conditions
- Breastfeeding, Exclusive
- Being tested
- Avocado
- Keywords
- Breastfeeding, Avocados, Infant cognition
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvocadoDietary supplement
Intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Avocado | Experimental | Participants will be provided avocados and asked to consume an avocado a day for 12 weeks. Receives: Dietary Supplement: Avocado |
| No Avocado | No intervention | Comparison arm in which no intervention occurs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Week 6 (at 4.5 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start8 Feb 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Avocado Nutrition Center
- Responsible party
- Sponsor
- Investigators
- Carol L Cheatham, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208085
- Sponsor's protocol ID
- 23-2933
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To ensure long-term findability, accessibility, interoperability, and reusability, the de-identified data from participants who agree to sharing and the codebook will be deposited in the UNC Dataverse, a generalist data repository managed by the Odum Institute at the University of North Carolina at Chapel Hill.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Avocado Intervention to Increase the Nutrients in Human Milk in Support of Infant Cognitive Development
- ClinicalTrials.gov ID
- NCT06208085
- Acronym / sponsor ID
- 23-2933
- Conditions
- Breastfeeding, Exclusive
- Keywords
- Breastfeeding, Avocados, Infant cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Avocado Nutrition Center
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To document whether lactating mothers will comply in the consumption of 5 avocados a week for 12 weeks.
- To ascertain the choline, lutein, and fatty acids present in human milk in women who eat avocado.
- 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.
Detailed description
Nutrients do not appear in nature alone with some appearing together more often than not. It is reasonable to posit that nutrients are working together, and thus, the synergies among the nutrients are important to understand. First, choline is integral to brain fatty acids in that phosphatidylcholine (PC) serves an active role in mediating hepatic export of fatty acids to extra-hepatic tissues such as brain: fatty acids are stored in the liver, and PC moves them to the brain. Erythrocyte PC-DHA is integral to our consideration of a potential mechanism behind our results. Enriched in docosahexaenoic acid (DHA), PC comprises the cell membrane and influences membrane fluidity with downstream effects on signal transduction thereby improving speed of processing and recognition memory. Lutein has a very important role also in that it is known to co-localize with DHA specifically resulting in improvements in visual acuity, for example, and in general, it has been shown to protect fatty acids from peroxidation. Indeed, interventions with avocado have shown a significant increase in plasma lutein and a decrease in lipid peroxidation. It is hypothesized that lutein is also having this effect in the brain. As work with single nutrient supplementation does not yield strong cognitive effects, the investigators study the effects of co-occurring nutrients on cognitive development. The proposed study is designed to achieve an overall objective of establishing a whole food, avocado, as a viable study material in the pursuit of optimization of human milk with nutrients that support brain development. The long-term goal is to establish guidelines for maternal nutrition during gestation and lactation that include key nutrients for fetal and infant brain development, and the overall impact of this research program will be to set children on a trajectory for school readiness. The central hypothesis is that maternal avocado consumption will provide nutrients through human milk to support the development and function of neural substrates that support cognition. Specifically, choline, lutein, and fatty acids will work synergistically to improve brain function.
Mothers will be randomized to avocado or no avocado (due to lack of an appropriate control food). Participants will come to the lab 3 times across 6 months (enrollment/3months, 4.5 months, and 6 months). Milk sample will be provided every two weeks and will be picked up from the participants. At pickup, the avocado group will also be provided a new supply of avocados. Diet data will be collected at each visit/pickup (every two weeks). The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 and 6 months. Saliva samples will also be collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Avocado | Experimental | Dietary Supplement: AvocadoParticipants will be provided avocados and asked to consume an avocado a day for 12 weeks. |
| No Avocado | No intervention | –Comparison arm in which no intervention occurs. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvocadoIntervention arm | Dietary supplement | Avocado |
Primary outcome
Recognition Memory in an Oddball Task
Time frame: Week 12 (at 6 months of age)
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.
Change in Choline Content of Milk
Time frame: Baseline, Week 12
Human milk will be assayed for choline every two weeks and analyzed for change over time (7 data points across 12 weeks).
Change in Lutein Content of Milk
Time frame: Baseline, Week 12
Human milk will be assayed for lutein every two weeks and analyzed for change over time (7 data points across 12 weeks).
Change in Fatty Acid Content of Milk
Time frame: Baseline, Week 12
Human milk will be assayed for fatty acids every two weeks and analyzed for change over time (7 data points across 12 weeks).
1 secondary outcome
Bayley Scales of Infant Development (BSID)
Time frame: Week 6 (at 4.5 months of age)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. To ensure long-term findability, accessibility, interoperability, and reusability, the de-identified data from participants who agree to sharing and the codebook will be deposited in the UNC Dataverse, a generalist data repository managed by the Odum Institute at the University of North Carolina at Chapel Hill.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carol L Cheatham, Ph.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avocado in people with Breastfeeding, Exclusive, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol L Cheatham, Ph.D. (704-250-5010, carol_cheatham@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognition Memory in an Oddball Task (time frame: Week 12 (at 6 months of age)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.