Iron-Fortified Formula for Infant Development

No longer recruiting at 39 trial locations

Overseen By Patrick McCarthy, JD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Aussie Bubs, Inc.

Disqualifiers: Health conditions impacting feeding

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well different iron-fortified formulas support infant growth. Researchers aim to measure the weight gain of healthy, full-term babies over four months while they consume one of four formula types, including grass-fed cow's milk, goat milk, and an organic option. Healthy, full-term babies without health issues affecting feeding or growth may be suitable for this study. As an unphased trial, it provides a unique opportunity for parents to contribute to the understanding of infant nutrition and growth.

Do I need to stop my baby's current medications for the trial?

The trial protocol does not specify if you need to stop your baby's current medications.

Do I need to stop my baby's current medications for the trial?

The trial information does not specify whether infants need to stop taking any current medications.

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

Research shows that the different infant formulas in this trial have varying safety profiles.

For the grass-fed cow's milk formula, past studies on similar products have raised concerns about milk-based formulas possibly increasing the risk of anemia. However, these formulas often contain organic ingredients that some infants may find easier to digest.

Goat milk-based formulas have been tested and found safe in previous studies. They are known for being easy to digest because they form smaller protein clumps, which can help improve gut health and nutrient absorption in infants.

The cow's milk formula without A1-beta casein has been studied for its potential to reduce digestive issues. Research suggests that milk without A1-beta casein may cause fewer stomach problems compared to regular milk, which might be linked to inflammation.

All formulas in this trial meet FDA nutrient requirements, indicating their safety. However, as with any infant formula, monitoring for individual reactions or sensitivities is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these infant formulas because they offer diverse nutritional bases that could enhance infant development in unique ways. Study Formula 1 uses grass-fed cow's milk, which may offer higher levels of certain nutrients compared to conventional milk. Study Formula 2 is based on goat milk, which some believe to be easier to digest for infants. Study Formula 3 is distinctive for excluding A1-BetaCasein, a protein that some think could cause digestive discomfort. Unlike standard formulas that often rely on non-organic sources, Study Formula 4 is USDA Organic and fortified with iron, potentially providing a cleaner option for parents concerned about organic nutrition. These variations in milk sources and nutritional profiles aim to address different dietary needs and preferences, giving parents more tailored options for their infants' growth and development.

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

This trial will compare different iron-fortified infant formulas. Studies have shown that iron-fortified cow's milk formula, one of the study formulas, effectively boosts iron levels in babies, with research indicating better iron levels compared to regular cow's milk. Another formula under study, the goat milk formula, supports similar growth to cow's milk formula and offers added benefits like improved gut health. Research on the cow's milk formula without A1-beta casein, also part of this trial, suggests it may cause fewer stomach problems than regular milk. Each of these formulas meets nutritional standards and supports healthy growth in babies. ^{1 3 6 7 8}

Who Is on the Research Team?

Keith Aqua, MD

Principal Investigator

Backtee Holdings, LLC

Are You a Good Fit for This Trial?

This trial is for healthy babies born at full term. It's not suitable for infants with health issues that could affect how they feed or grow.

Inclusion Criteria

My baby was born at full term and is healthy.

Exclusion Criteria

Any health condition that would negatively impact infant feeding and growth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants are fed iron-fortified infant formulas ad-libitum and monitored for growth and tolerance

16 weeks

5 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

• Infant Formula

Trial Overview

The study tests the growth effects of iron-fortified infant formula over a period of 4 months, monitoring weight gain and overall development in these infants.

How Is the Trial Designed?

Group I: Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein Experimental Treatment 1 Intervention

Infant Formula meets all nutrient requirements of the FDA.

Group II: Study Formula 2_Goat Milk Infant Formula Experimental Treatment 1 Intervention

Infant Formula meets all nutrient requirements of the FDA.

Group III: Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula Experimental Treatment 1 Intervention

Infant formula meets all nutrient requirements of the FDA.

Group IV: Study Formula 4_USDA Organic iron fortified infant formula Active Control 1 Intervention

Infant Formula meets all nutrient requirements of the FDA.

Infant Formula is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Infant Formula for:

• Nutritional supplement for infants

Approved in European Union as Infant Formula for:

• Nutritional supplement for infants

Approved in Canada as Infant Formula for:

• Nutritional supplement for infants

Who Is Running the Clinical Trial?

Aussie Bubs, Inc.

Lead Sponsor

Trials

1

Recruited

440+

Validcare

Collaborator

Validcare CRO

Collaborator

Published Research Related to This Trial

Soy infant formulas (SIF) are effective for managing cow's milk allergy and have a low risk of cross-allergy, making them a suitable alternative for infants with specific dietary needs.

SIFs demonstrate a good safety profile and offer advantages in cost, taste, and positive effects on gut microbiota, although evidence for their use in functional digestive disorders is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recomendaciones sobre la utilización de las fórmulas infantiles con proteína aislada de soya en la alimentación del lactante. Documento de posición basado en la evidencia]. Gutiérrez-Castrellón, P., Vázquez-Frías, R., Jiménez-Gutiérrez, C., et al.[2023]

A case study of a 9-month-old infant with renal disease showed that using Renastart pediatric renal formula alongside expressed breast milk improved growth and maintained normal serum electrolyte levels, indicating its efficacy for infants with renal impairment.

The study highlights the importance of monitoring protein intake and electrolytes when using Renastart, suggesting that phosphorus supplementation may be necessary, and calls for larger studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renastart Use in an Infant on Peritoneal Dialysis. Keung, LG.[2019]

Preterm infants fed Similac With Iron showed better absorption and retention of calcium, phosphorus, and zinc compared to those fed Similac With Whey + Iron, which is crucial for their growth and development.

Despite the benefits of both formulas, the retention of essential minerals like calcium, phosphorus, and zinc was still inadequate to meet the estimated fetal requirements, highlighting a risk for deficiencies in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrient retention in preterm infants fed standard infant formulas. Cooke, RJ., Nichoalds, G.[2019]

Both milk-based, iron-fortified formulas containing 7.4 mg/L and 12.7 mg/L of iron support normal growth and iron status in healthy infants during their first year, as shown in a study of 347 infants, with 172 included in the final analysis.

There were no significant differences in growth, formula tolerance, or iron levels between the two formula groups, indicating that both iron levels are effective and well-tolerated options for infants who are not breast-fed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of two iron-fortified, milk-based formulas during infancy. Bradley, CK., Hillman, L., Sherman, AR., et al.[2013]

In a study involving 16 adult women, iron absorption from a soy formula was found to be very low at only 1.7%, indicating that soy products may inhibit iron absorption.

Despite this low absorption rate in adults, a study of 47 infants showed that those fed soy formula had similar iron nutritional status and low anemia rates compared to those fed iron-fortified cow's milk, suggesting that soy formula can effectively prevent iron deficiency in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability of iron in soy-based formula and its effect on iron nutriture in infancy. Hertrampf, E., Cayazzo, M., Pizarro, F., et al.[2023]

In a study examining the stability of vitamins and minerals in the Similac Special Care formula for premature infants, significant reductions in calcium (44-54%), iron (23-34%), and zinc (18-32%) were observed after continuous infusion, indicating that infants may not receive the expected amounts of these nutrients.

In contrast, another formula, Similac 24LBW, showed stable concentrations of all vitamins and minerals tested, suggesting that it may be a more reliable option for ensuring nutrient delivery in premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability of vitamin and mineral concentrations of a low-birth-weight infant formula during continuous enteral feeding. Antonson, DL., Smith, JL., Nelson, RD., et al.[2019]

A study involving 45 infants aged 1-6 months found that the new Israeli soy formula, Materna Tsimchit, is as effective as the well-known Isomil formula in managing cow-milk allergy and lactose intolerance over a 2-month period.

No significant differences were observed between the two formulas in terms of compliance, behavior, growth parameters, and overall health assessments, suggesting that Materna Tsimchit is a viable alternative to Isomil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a new Israel infant soy formula]. Weizman, Z.[2023]

In a study involving 967 healthy infants, the new infant formula (NF) was found to be well tolerated, showing stool consistencies that were softer than those of other marketed formulas (OF) and more similar to those of infants fed human milk (HM).

There were no significant differences in gastrointestinal intolerance symptoms among the different feeding regimens, indicating that all formulas, including NF, were well tolerated by the infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal tolerance of a new infant milk formula in healthy infants: multicenter study conducted in Taiwan. Chen, N., Alarcon, PA., Comer, GM., et al.[2019]

Soya-based infant formulas (SIF) have been found to support growth and bone health in children similarly to cow's milk-based formulas (CMF) and human milk (HM), despite concerns about their safety.

The study showed no significant negative effects on reproductive, endocrine, immune, or cognitive functions in children fed SIF compared to those fed CMF or HM, indicating that modern SIF can be a safe alternative for infants with specific dietary needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of soya-based infant formulas in children. Vandenplas, Y., Castrellon, PG., Rivas, R., et al.[2014]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12264312/

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Consumption of milk free of A1‐type β‐casein (A1PF) can result in reduced gastrointestinal/inflammatory symptoms versus conventional milk ...

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(PDF) Effect of Infant Formula Made With Milk Free of A1‐ ...

PDF | Consumption of milk free of A1‐type β‐casein (A1PF) can result in reduced gastrointestinal/inflammatory symptoms versus conventional milk.

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mdpi.com

mdpi.com/2304-8158/6/7/50

Production of Cow's Milk Free from Beta-Casein A1 and Its ...

This work was aimed to produce milk containing BC A2 with no BC A1 (BC A2 milk) using genetically selected CSN2 A2A2 Jersey cows.

5.

semanticscholar.org

semanticscholar.org/paper/Production-of-Cow%E2%80%99s-Milk-Free-from-Beta-Casein-A1-Duarte-V%C3%A1zquez-Garc%C3%ADa-Ugalde/318d646c6af717f7dadcf455e683b46b8650356e

Production of Cow's Milk Free from Beta-Casein A1 and Its ...

It is demonstrated that using BC A2 milk in IF formulation significantly reduces BCM7 formation during SGID, and an infant formula suitable for healthy ...

6.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/abs/10.1002/fsn3.70606

Effect of Infant Formula Made With Milk Free of A1‐Type β‐ ...

Consumption of milk free of A1-type β-casein (A1PF) can result in reduced gastrointestinal/inflammatory symptoms versus conventional milk ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0022316622001407

Beneficial Effects of Milk Having A2 β-Casein Protein

A1 milk consumption has been associated with enhanced inflammatory markers. It has also been reported to have an opioid-like response that can lead to ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11959105/

Effect of A1 protein‐free formula versus conventional ...

Milk free of A1 β‐casein (A1PF milk) may support the immune system, but few studies have investigated A1PF milk in toddler formula and any ...