Background

Human milk is the gold standard for infant nutrition, enriched with bioactive components that support immune, gastrointestinal, and neural development. One such component, osteopontin (OPN), is significantly abundant in human milk but occurs in much lower concentrations in bovine milk. Interest has grown in supplementing infant formula with bovine milk osteopontin (bmOPN) to replicate the physiological roles of human milk OPN (hmOPN).

However, the safety and physiological impact of bmOPN remain topics of scientific scrutiny. To address these concerns, an expert panel convened to evaluate existing data, focusing on the safety of bmOPN in infant nutrition to address FDA concerns and identify critical research gaps.

What we did

We formed a committee to identify and invite academic experts to a 2-day in-person workshop. Traverse specifically assisted with the planning of the scientific agenda, delegating review topics, and moderating during the workshop. Traverse led post-workshop additional meetings, fact checking, conduct of the narrative review, and manuscript writing and journal submission.

You can read the full article published in Frontiers in Nutrition here.

Disclaimer: This work was financially supported by Arla Foods Ingredients Group P/S (AFI) and Building Block Nutritionals, LLC (BBN). Conduct of the narrative review, original manuscript, and draft were completed independently by authors only.

Key Takeaways

• Exposure and Absorption
  • Human Milk OPN (hmOPN) is present at 250–350 mg/L in colostrum, declining to 65–250 mg/L in mature milk.
  • In contrast, standard infant formulas contain 9–15 mg/L of bmOPN.
  • Dietary bmOPN is partially resistant to digestion and is absorbed into the bloodstream, though it accounts for less than 5% of total plasma OPN in formula-fed infants.
• Physiological Impact
  • Immune Development: bmOPN supplementation has been shown to modulate immune responses, shifting immune markers closer to those observed in breastfed infants.
  • Gastrointestinal Development: Preclinical studies suggest bmOPN can influence intestinal growth and cell proliferation without adverse effects.
  • Neurodevelopment: Animal studies indicate that bmOPN may support myelination and cognitive development, although this has not been studied in humans.
• Safety Profile
  • No adverse effects on growth, gastrointestinal health, immune function, or neurodevelopment have been reported in preclinical or clinical studies.
  • Functional Bioequivalence: Studies comparing bmOPN with human and recombinant forms of OPN found similar absorption and physiological effects.
  • Regulatory Status: While the European Food Safety Authority (EFSA) deems bmOPN safe at concentrations up to 151 mg/L, the U.S. FDA has not approved its use in infant formula, citing gaps in long-term safety data and uncertainty regarding mechanisms of action of its bioactivity.

Research Gaps & Recommendations

More research is needed to evaluate the long-term impacts of bmOPN on cognitive and immune development and to reproduce the current findings.