Egg Supplementation for Infant Cognitive Development During Breastfeeding

(ICAN Trial)

Overseen By Study Coordinator

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Developmental delay, Egg allergy, Gestational diabetes, Seizure activity

Compensation: Varies

Number of Visits: 6

Duration: 13 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding whole eggs to a breastfeeding mother's diet can boost her baby's brain development. Researchers compare the effects of whole egg powder, rich in nutrients like choline and lutein, to egg white powder, which lacks these nutrients. The study invites healthy mothers aged 18-35 who had full-term babies and consume low amounts of these key nutrients. Participants will visit the lab three times over three months to track diet and collect health samples. As an unphased study, this trial offers a unique opportunity for mothers to contribute to understanding how diet can enhance infant brain development.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that whole egg powder is usually well-tolerated. One study found that replacing some foods with whole egg powder did not harm the thinking skills of children aged 9 to 12 over nine months, suggesting it can be safely included in the diet for an extended period without causing problems.

Another study found that nutrient-rich egg powder can help fight malnutrition in children under 5, supporting its safety for young children. While these studies focus on older children, they provide promising evidence about the safety of egg powder, which is important when considering its use for infants and breastfeeding mothers.

Egg white powder, while lacking some nutrients found in whole eggs, is still often used safely in foods. Since this trial compares whole egg powder to egg white powder, both have demonstrated safety in various situations and age groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using whole egg powder for infant cognitive development because it contains high levels of essential nutrients like choline, lutein, and docosahexaenoic acid (DHA), which are crucial for brain health. Unlike traditional infant supplements, which might lack these specific nutrients, whole egg powder provides a natural and concentrated source. Choline supports brain function, lutein plays a role in eye health, and DHA is vital for brain development. This nutrient-rich approach could offer a more comprehensive benefit to infants' cognitive growth during breastfeeding.

What evidence suggests that this trial's treatments could be effective for infant cognitive development?

Research has shown that whole eggs contain important nutrients like choline, lutein, and DHA, which aid brain development. One study found that eating eggs can improve nutrition and may boost brain growth in children. These nutrients support memory and learning. In this trial, participants will receive either whole egg powder, which contains these key nutrients, or egg white powder, which lacks choline, lutein, and DHA. Although more research is needed for infants, the nutrients in whole eggs appear promising for supporting brain growth in babies during breastfeeding. ^{1 2 3 4 6}

Who Is on the Research Team?

Carol L Cheatham, Ph.D.

Principal Investigator

Associate Professor, University of North Carolina-Chapel Hill

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My infant is between 12 to 15 weeks old.

You are not consuming enough of the recommended amounts of DHA, choline, and lutein.

gave birth at >38 weeks gestation without remarkable incident

Exclusion Criteria

I have had seizures.

My infant is suspected to have or has been diagnosed with developmental delay.

gestational diabetes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mothers are randomized to receive either whole egg or egg white powder, with diet intake screened using the NDSR. Milk, saliva, and plasma samples are collected from mothers and infants at 3, 4.5, and 6 months.

13 weeks

3 visits (in-person)

Assessment

Infants complete a recognition memory test using electrophysiology at 6 months and the Bayley Scales of Infant Development at 4.5 months. Mothers complete a temperament questionnaire at 3 and 6 months.

13 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Egg White Powder
• Whole Egg Powder

Trial Overview 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.

How Is the Trial Designed?

Group I: Whole egg powder Experimental Treatment 1 Intervention

Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.

Group II: Egg white powder Placebo Group 1 Intervention

The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid).

Egg White Powder is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Egg White Powder for:

• General nutritional supplement
• Food ingredient

Approved in European Union as Egg White Powder for:

• General nutritional supplement
• Food ingredient

Approved in Canada as Egg White Powder for:

• General nutritional supplement
• Food ingredient

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Egg Nutrition Center

Collaborator

Trials

16

Recruited

1,300+

Published Research Related to This Trial

In a study involving 163 very low birth weight (VLBW) infants, fortifying human milk with infant formula significantly improved weight gain and linear growth compared to exclusive human milk, indicating a beneficial alternative for growth in resource-limited settings.

The study found no significant differences in biochemical parameters or rates of complications like sepsis and necrotizing enterocolitis between the two groups, suggesting that the fortification method is safe for VLBW infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing the effect of fortification of human milk with an infant formula powder versus unfortified human milk on the growth of preterm very low birth weight infants. Gupta, V., Rebekah, G., Sudhakar, Y., et al.[2022]

A standardized bovine colostrum derivative was developed through a careful process involving collection within five hours after delivery, followed by centrifugation, filtration, and lyophilization, ensuring a stable and sterile product.

The final colostrum product contains significant and reproducible amounts of bioactive components such as cytokines, immunomodulating factors, growth factors, and immunoglobulins, making it a potentially effective supplement for immune support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological components in a standardized derivative of bovine colostrum. Sacerdote, P., Mussano, F., Franchi, S., et al.[2013]

Human milk contains important proteins like α-lactalbumin and lactoferrin that contribute to the health benefits of breastfeeding, and there is potential to add similar bovine proteins to infant formula to enhance its nutritional value.

When adding bioactive proteins to infant formula, it's crucial to reduce the total protein content to avoid higher serum amino acid levels in formula-fed infants, while ensuring that the amino acid composition remains comparable to that of breastfed infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant formula and infant nutrition: bioactive proteins of human milk and implications for composition of infant formulas. Lönnerdal, B.[2023]

A multicomponent additive made from hen eggs, including lysozyme hydrolysate and a yolk-fatty emulsion, was developed to enhance milk mixtures for infants, making them closer in composition to human milk.

Clinical trials demonstrated that these enriched milk mixtures are highly effective for both healthy and sick infants, indicating a promising nutritional intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A multicomponent additive intended for preparing infant milk mixtures enriched with essential and protective factors]. Sharmanov, TSh., Fedotov, PV., Elantsev, AB.[2006]

Infants who received formula with added bovine milk fat globule membrane (MFGM) and lactoferrin showed significantly improved cognitive, language, and motor development scores at 365 days compared to those on standard cow's milk-based formula, indicating enhanced neurodevelopmental outcomes.

The MFGM + lactoferrin group experienced fewer respiratory-related adverse events and instances of diarrhea, suggesting that this formula not only supports growth and development but also promotes better overall health in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. Li, F., Wu, SS., Berseth, CL., et al.[2020]

Oral iron treatment effectively corrected iron deficiency anemia (IDA) in 21 out of 24 children within 6 to 12 weeks, regardless of whether they were fed whole cow's milk or soy formula.

Fecal blood loss was minimal and similar in both groups, and protein-losing enteropathy (PLE) associated with IDA resolved after the anemia was treated, indicating that both dietary options are safe and effective for managing IDA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of iron deficiency anemia and associated protein-losing enteropathy in children. Nickerson, HJ., Silberman, T., Park, RW., et al.[2019]

In a field trial involving 105 newborn calves across 14 farms, feeding egg powder with specific antibodies against E. coli K99 and rotavirus significantly reduced the frequency of diarrhea from 68.5% to 52.9%.

Calves infected with E. coli K99 experienced a dramatic decrease in diarrhea incidence from 92.3% to 30.7%, and those solely infected with E. coli K99 had a complete resolution of diarrhea, alongside a significant reduction in duration and severity of diarrhea compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New possibilities in oral immunoprophylaxis of newborn diarrhea in calves--a field study using specific egg antibodies]. Erhard, MH., Kellner, J., Eichelberger, J., et al.[2020]

In a study involving 277 Malawian infants, those who received a daily supplement of bovine colostrum with egg powder (BC/egg) showed significantly less linear growth faltering compared to those receiving a corn/soy flour control, with a notable difference in length-for-age z-scores (ΔLAZ) after 3 months.

The BC/egg group also had a lower prevalence of stunting at 17 months, indicating that this supplement may help improve growth outcomes in infants, particularly those with severe environmental enteric dysfunction (EED).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of bovine colostrum/egg supplementation compared with corn/soy flour in young Malawian children: a randomized, controlled clinical trial. Bierut, T., Duckworth, L., Grabowsky, M., et al.[2023]

In a study involving 34 critically ill patients with respiratory failure, egg white protein powder supplementation did not show a significant difference in serum prealbumin (PAB) levels compared to casein protein after 7 days of enteral nutrition support.

Both protein sources were found to be equally effective in maintaining PAB levels, suggesting that egg white powder can be a viable alternative to casein for protein supplementation in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change of serum prealbumin levels and serum protein markers between egg white powder and casein protein additives in standard enteral feeding formulas in critically ill patients with acute respiratory failure. Bhurayanontachai, R., Sa-Nguansai, S.[2020]

Oral administration of active egg white product (AEWP) significantly boosts the immune response in mice, enhancing their resistance to infections like E. coli.

AEWP not only helps prevent infections but also shows therapeutic effectiveness against existing S. aureus infections in mice, indicating its potential as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced resistance to bacterial infections in mice by oral administration of an active egg white product. Araki, S., Suzuki, M., Fujimoto, M.[2019]

The EFSA Panel concluded that whey basic protein isolate from skimmed cow's milk is safe for human consumption, including its use in infant formulas and food supplements, based on a review of its safety in 2018.

The Panel determined that extending the use of whey basic protein isolate in infant formulas and food supplements would not increase the potential intake beyond previously assessed levels, confirming its safety at these new proposed uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283. Turck, D., Castenmiller, J., de Henauw, S., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-1-2019-6d039

Egg Supplementation for Infant Cognitive Development ... Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10900354/

Eggs for Improving Nutrition, cognitive development and ... This study aims to examine the impact of an egg intervention in children, along with behaviour change communication (BCC) to the mother, on linear growth and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523036997

The effects of 9 months of formulated whole-egg or milk ... Replacement of foods with added whole egg powder does not impact 9-month changes in preadolescent executive functions. This trial was registered at ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12256981/

Nutritional Composition and Acceptability of Egg Powder‐ ... The composite had enhanced protein (18.09%) and carbohydrates (61.99%), with improved iron, zinc, magnesium, vitamin A, and folate levels.

5. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)03699-7/pdf

The effects of 9 months of formulated whole-egg or milk ... The primary outcomes were 3 NIH. Toolbox-Cognitive Battery measures of executive function: mental flexibility, working memory, and selective ...

6. supplysidefbj.com supplysidefbj.com/food-ingredients/study-highlights-egg-powder-s-potential-to-combat-malnutrition-in-children

Egg powder may be the answer to avoiding malnutrition in ... With a greater concentration of nutrients, spray-dried egg powder can help fight malnutrition in children under 5, according to a new study.