Conducted in Singapore, the RCT measures the impact of the formula on the babies yearly up until they reach five years old. For example, their weight gain, BMI-for age z-score, immunological, microbial, and cognitive outcomes will be measured.
The infant formula of interest contains milk droplets of novel lipid structure and is not yet commercially available.
The concept, trademarked Nuturis, is about how infant formula could better mimic mothers’ milk by designing products with larger milk droplets – having a mode diameter of three to five micrometre – and are covered by phospholipids, milk proteins, and cholesterol.
Regular infant formula produces small droplets only covered by milk proteins, while human milk consists of large droplets – with a mode diameter of four to 10 micrometre – and are covered by a phospholipid trilayer, membrane proteins, and cholesterol.
In fact, it is the specific surface composition and size of the lipid globules in human milk that have been shown to play a role in the gut maturation, as well as the development of immune and central nervous systems in infants.
Based on existing findings, the researchers believe that introducing infant formula with more complex lipid structure, by more closely mimicking mothers’ milk, would enable growth patterns seen in breastfed infants.
In this RCT, infants recruited into the study have been randomised into three groups, consuming either 1) Nuturis alongside prebiotics, or 2) a standard infant formula with prebiotics, or 3) a standard infant formula without prebiotics.
Parents were encouraged to continue breastfeeding and could decide to introduce the formula at any time within their babies’ first year of life.
A total of 336 infants have been randomised into the three study arms.
Aside from physical growth, stool, saliva and buccal smear samples assessing safety, gastrointestinal tolerance and cognitive outcomes would be collected.
The clinical study, sponsored by Danone Asia Pacific Holdings, involves researchers from A*STAR, National University of Singapore, Nutricia Research, KK Women’s and Children’s Hospital, and the University of Groningen in The Netherlands.
Milk is complex
Responding to queries from NutraIngredients-Asia, the company pointed out that it has been studying the combination of different nutrients in its research of breast milk.
“We have been studying breast milk for over 50 years, it is a complex substance and the magic of it is in the interplay of its components.
“That’s why with our innovations, we aim to achieve a combination of lipids, proteins, lactose, prebiotic oligosaccharides, vitamins, minerals and beneficial metabolites like postbiotics inspired by the quantity, diversity and functionality of components in breast milk,” Dr. Rocio Martin, Director, Medical Affairs at Danone Specialized Nutrition said.
In the case of lipids, it is an essential component, with fats being the second largest group of macronutrients in breast milk.
“Lipids provide essential fatty acids and serve as an energy source essential for healthy growth whilst supporting the development of a baby’s brain and immune system.
“As part of our research programs we study both the impact of lipid structure as well as composition on growth, body composition and metabolic development during the first years of life.
“At present, we continue to study dietary lipid structure and composition, the concept [of Nuturis] is currently not on the market,” she said.
The Nuturis concept has been proven safe and well-tolerated when consumed by healthy infants up to four months old.
An earlier proof-of-concept study also suggested that fats and carbohydrates from infant formula developed with the concept were more rapidly absorbed by the body.
On the other hand, reduced body fat accumulation during adulthood was seen in mice fed with the formula when they were between 15 and 42 days old.
This was because the formula had improved metabolic profile, with a reduction of fasting plasma leptin, resistin, glucose and lipids.