Abstract
Human milk oligosaccharides (HMOs) are complex sugars that occur naturally in human breast milk and provide many beneficial functions. Most formula products lack HMOs or contain only the most abundant HMO, 2′-fucosyllactose; however, benefits of HMOs come from multiple sugars. We therefore developed a mixture of five HMOs (5HMO-Mix) mimicking the natural concentrations of the top five HMOs (5.75 g/L total, comprising 52% 2′-fucosyllactose, 13% 3-fucosyllactose, 26% lacto-N-tetraose, 4% 3′-sialyllactose, and 5% 6′-sialyllactose) representing the groups of neutral, neutral-fucosylated, and sialylated HMOs. We conducted the first multicenter, randomized, controlled, parallel-group clinical study assessing the safety, tolerability, and effect on growth of formula containing the 5HMO-Mix in healthy infants. We enrolled 341 subjects aged ≤14 days; 225 were randomized into groups fed either with infant formula containing 5HMO-Mix (5HMO-Mix) or infant formula without HMOs (IF) for 4 months, with the others exclusively breastfed. There were no differences in weight, length, or head circumference gain between the two formula groups. The 5HMO-Mix was well tolerated, with 5HMO-Mix and breastfed infants producing softer stools at a higher stool frequency than the control formula group. Adverse events were equivalent in all groups. We conclude that the 5HMO-Mix at 5.75 g/L in infant formula is safe and well tolerated by healthy term infants during the first months of life.
Highlights
Breastfeeding is the most effective way to ensure infant health because human breast milk provides a nutritionally complete meal as well as all the bioactive components needed for optimal development during the first months of life [1]
As an example, sialylated human milk oligosaccharides (HMOs) and 2 -fucosyllactose (2 -FL) have been reported to impact brain development and learning capacities [22,23,25], nonfucosylated HMOs are a preferred substrate for specific bifidobacteria [8], and HMOs from different classes act as decoys to prevent adhesion of specific viral or bacterial pathogens to receptors on human cells [28]
To provide infant formulae that match the HMO profile of natural breast milk as closely as possible, we developed a mixture of five HMOs (5HMO-Mix) that combines the five most abundant HMOs across all three structural classes, aiming for synergistical and complementary beneficial effects for the infant’s development
Summary
Breastfeeding is the most effective way to ensure infant health because human breast milk provides a nutritionally complete meal as well as all the bioactive components needed for optimal development during the first months of life [1]. HMOs are known to perform a range of beneficial physiological functions including the establishment and maintenance of a healthy gut microbiome [4,5,6,7,8,9,10,11,12,13,14], the development of the immune system and modulation of inflammatory responses [1,15,16,17], the strengthening of the gastrointestinal barrier [18,19], and the promotion of neuronal development and cognitive function [20,21,22,23,24,25] These health-promoting effects have been extensively reviewed elsewhere [1,15,26,27]. More research and clinical application is necessary to explore defined functions of specific HMOs and to investigate synergistic effects of HMOs in blends
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