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Avocado Consumption for Exclusive Breastfeeding

N/A
Recruiting
Led By Carol L Cheatham, Ph.D.
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Any documented seizure activity in infant
Infant with diagnosis or documented suspicion of developmental delay
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 (at 4.5 months of age)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study if eating avocados can provide important nutrients for brain development in breastfeeding mothers and their infants. The study will involve 88 breastfeeding pairs, who will be asked to consume

Who is the study for?
This trial is for healthy breastfeeding women who are 13 weeks postpartum and their infants. Participants will be asked to eat an avocado a day for 12 weeks. The study aims to see if avocados in the mother's diet can improve nutrients in breast milk and benefit infant brain development.
What is being tested?
The study tests whether eating five avocados per week affects the levels of choline, lutein, and fatty acids in human milk, which are important for infant brain development. It also looks at potential cognitive benefits for infants whose mothers consume avocados.
What are the potential side effects?
Since this trial involves consuming avocados as part of a regular diet, no significant side effects are expected beyond typical food-related responses such as allergies or individual sensitivities.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My infant has had seizures.
Select...
My child is suspected to have or has been diagnosed with developmental delay.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6 (at 4.5 months of age)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 (at 4.5 months of age) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Choline Content of Milk
Change in Fatty Acid Content of Milk
Change in Lutein Content of Milk
+1 more
Secondary study objectives
Bayley Scales of Infant Development (BSID)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AvocadoExperimental Treatment1 Intervention
Participants will be provided avocados and asked to consume an avocado a day for 12 weeks.
Group II: No AvocadoActive Control1 Intervention
Comparison arm in which no intervention occurs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avocado
2011
N/A
~70

Find a Location

Who is running the clinical trial?

Avocado Nutrition CenterUNKNOWN
2 Previous Clinical Trials
446 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,619 Total Patients Enrolled
Carol L Cheatham, Ph.D.Principal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
352 Total Patients Enrolled
~59 spots leftby Dec 2028
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