Mimicking human breast milk: Another novel synthetic formula ingredient on the horizon?

Danish biotech firm Glycom has filed another application for a synthetic version of a compound found in breast milk, a development one infant formula expert said was promising.

According to the European Food Safety Authority’s (EFSA) register of questions, a novel food application is now under consideration for N-Acetyl-D-neuramicin acid after being forwarded on by the European Commission.

Dr Sandra Einerhand, founder and consultant at Einerhand Science & Innovation, said Glycom's filing was interesting in the mimicry of the ‘golden standard’ of breast milk in infant formula production.

“This is certainly of interest and it will be another step to bringing infant formula closer to human breast milk, because human milk contains a large amount of sialic acid compared with bovine milk,” said Einerhand, who worked previously as scientific programme director at Danone Nutricia Early Life Nutrition.

“However it is of note that sialic acid in human milk is mostly contained in oligosaccharides, glycolipids and glycoproteins in milk and is considered to play important roles in physiological functions in infancy. The levels of free sialic acid in human milk are very low.”

Described as an endogenous human and ubiquitous nutritional monosaccharide, N-Acetyl-D-neuraminic acid is most commonly referred to as sialic acid.

Emerging data 

Discussing the profile of free N-Acetyl-D-neuraminic acid or sialic acid, a 2015 paper said there was “emerging data” demonstrating it is linked to “positive nutritional effects including pronounced anti-oxidative properties” and past research has suggested it is important for brain health.

“These data and the extremely high safety profile of N-Acetyl-D-neuraminic acid (NANA) justify dietary enrichment at levels that correspond to the dietary intake of NANA in infants through breast milk,” the researchers wrote.

This latest filing with EFSA follows similar investigations into the safety of two synthetic oligosaccharides – lacto-N-neotetraose (LNnT) and 2'-O-fucosyllactose (2'-FL) – after novel food applications from Glycom.

Finding the missing jigsaw pieces

EFSA confirmed the safety of these two synthetic oligosaccharides - opening the door for their use in infant and follow-on formula.

However a few months later a second evaluation from EFSA’s dietetic products, nutrition and allergies (NDA) panel focusing on children aged one to 10 raised some concerns about mild gastrointestinal symptoms.

Discussing Glycom’s latest applications, Einerhand said this was a “very nice addition” because sialic acids had been “lacking” in most prebiotics on the infant formula market to date and likewise Glycom’s two recently approved human milk oligosaccharides do not contain sialic acid either.

However she warned that human milk was “quite complex”, and so while these applications meant the industry was “getting closer to the composition of breast milk”, there was still a long way to go.

“[M]oreover, I haven’t seen a study in infants showing the effect of the free N-Acetyl-D-neuraminic acid and so a strong statement on the benefit of this compound cannot be made until clinical proof in infants is provided.”

Speaking at NutraIngredient’s event Probiota last year, Einerhand called for greater research into the mimicry of components of human breastmilk so that their health properties could be recreated in infant formula. 

While promising, she said the applications from Glycom represented just a few in hundreds of oligosaccharides naturally present in breastmilk. 

Glycom did not respond to our requests for comment in time for the publication of this article.