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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks (at 4.5 months of age)

Awards & highlights

ICAN Trial 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.

ICAN Trial 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.

ICAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks (at 4.5 months of age)

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)

ICAN 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).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Egg Nutrition CenterOTHER

13 Previous Clinical Trials

922 Total Patients Enrolled

University of North Carolina, Chapel HillLead Sponsor

1,506 Previous Clinical Trials

4,190,477 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this research?

"Confirming, the information on clinicaltrials.gov attests that this health study is recruiting participants currently. The trial was initially advertised on 2/5/2019 and had its most recent update on 5/19/2022. This research endeavour requires 84 individuals from 1 medical site to enrol in it."

Answered by AI

May I have the opportunity to participate in this research project?

"To join this clinical trial, participants must have been exclusively breastfeeding between 3 months and 35 months. The study is currently enrolling approximately 84 individuals."

Answered by AI

Are elderly individuals being included in the analysis of this trial?

"Patient qualifications for this study are narrow, with the age range of participants set between 3 months to 35 years old. Separately, there are 8 trials specifically targeting minors and 9 seeking older adults above 65 years old."

Answered by AI

What is the aggregate figure of participants engaged in this clinical experiment?

"Affirmative, according to the information published on clinicaltrials.gov, this research project is yet open for participants. Its initial posting dates back to February 5th 2019 and was last modified on May 19th 2022. Currently 84 volunteers are required at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Synergistic Activity of Human Milk Nutrients and Infant Cognition

Carol Cheatham, PhD 2019. "Synergistic Activity of Human Milk Nutrients and Infant Cognition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03838536.