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

Trial Summary

What is the purpose of this trial?

Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal. Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Initial diet intake will be screened using the NDSR. Participants will come to the lab 3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma will be collected from the mother, while saliva and plasma (heel stick) are collected from the infant. Diet data will be collected at each visit. 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 months and 6 months.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Egg White Powder, Egg White Protein Powder, Albumen Powder, Whole Egg Powder, Whole Egg Powder, Egg Powder, Dehydrated Egg for infant cognitive development during breastfeeding?

The research on egg white products shows that they can enhance resistance to infections in mice, suggesting potential health benefits. Additionally, egg white powder is used for protein supplementation in critically ill patients, indicating its nutritional value, which might support infant development. ^{1 2 3 4 5}

Is egg supplementation safe for humans?

There is limited safety data on egg supplementation in humans, but a study on critically ill patients using egg white powder for protein supplementation did not report any safety concerns. Additionally, egg powder has been used in animal studies without reported safety issues. ^{1 2 6 7 8}

How does egg supplementation during breastfeeding differ from other treatments for infant cognitive development?

Egg supplementation during breastfeeding is unique because it uses egg white and whole egg powders, which are rich in essential amino acids and nutrients that may support cognitive development. Unlike other treatments, this approach focuses on natural food sources rather than synthetic supplements or drugs. ^{3 8 9 10 11}

Research Team

Carol L Cheatham, Ph.D.

Principal Investigator

Associate Professor, University of North Carolina-Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Enhanced resistance to bacterial infections in mice by oral administration of an active egg white product. [2019]

2. England 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of iron deficiency anemia and associated protein-losing enteropathy in children. [2019]

5. England 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[New possibilities in oral immunoprophylaxis of newborn diarrhea in calves--a field study using specific egg antibodies]. [2020]

7. United States 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. [2020]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Biological components in a standardized derivative of bovine colostrum. [2013]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A multicomponent additive intended for preparing infant milk mixtures enriched with essential and protective factors]. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. [2020]