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Egg Supplementation for Infant Cognitive Development During Breastfeeding (ICAN Trial)

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
infant is 12-15 weeks of age at enrollment
healthy, lactating mother age 18-35
Must not have
any documented seizure activity
infant with diagnosis or documented suspicion of developmental delay
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks (at 4.5 months of age)
Awards & highlights

Summary

This trial is testing whether eggs can provide nutrients that support optimal brain development in mothers and infants. 84 breastfeeding dyads will be studied over the course of 3 months, with mothers being randomized to eating either whole eggs or egg whites. Data will be collected on diet, milk and saliva production, and infant development.

Who is the study for?
This trial is for healthy breastfeeding mothers aged 18-35, who gave birth at full term without complications and whose infants are 12-15 weeks old. Participants must be consuming less than half the recommended amounts of DHA, choline, or lutein. Those with egg allergies or a family history of it, gestational diabetes, or infants suspected of developmental delays cannot join.Check my eligibility
What is being tested?
The study tests if adding whole egg or egg white to the diet of breastfeeding mothers can improve brain development in their babies. Over three months, mother-infant pairs will visit the lab for dietary assessments and provide milk and saliva samples; infants will also undergo cognitive tests.See study design
What are the potential side effects?
Since this trial involves food supplementation with eggs, potential side effects may include digestive discomfort or allergic reactions in participants not previously identified with an egg allergy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My infant is between 12 to 15 weeks old.
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I am a healthy breastfeeding mother aged 18-35.

Exclusion Criteria

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

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recognition Memory in an Oddball Task
Other outcome measures
Bayley Scales of Infant Development (BSID)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Whole egg powderExperimental Treatment1 Intervention
Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.
Group II: Egg white powderPlacebo Group1 Intervention
The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid).

Find a Location

Who is running the clinical trial?

Egg Nutrition CenterOTHER
14 Previous Clinical Trials
1,028 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,526 Previous Clinical Trials
4,197,153 Total Patients Enrolled
Carol L Cheatham, Ph.D.Principal InvestigatorAssociate Professor, University of North Carolina-Chapel Hill
4 Previous Clinical Trials
356 Total Patients Enrolled

Media Library

Egg White Powder (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03838536 — N/A
Exclusive Breastfeeding Research Study Groups: Whole egg powder, Egg white powder
Exclusive Breastfeeding Clinical Trial 2023: Egg White Powder Highlights & Side Effects. Trial Name: NCT03838536 — N/A
Egg White Powder (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03838536 — N/A
~8 spots leftby Mar 2025
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