Safety evaluation of 3′-siallylactose sodium salt supplementation on growth and clinical parameters in neonatal piglets

Sialyllactose (SL) is an abundant oligosaccharide in human milk with health benefits that include intestinal maturation, gut microbiota modulation, and cognitive development. Recent technological advances support large scale production of different forms of sialyllactose, which will enable their use as a food ingredient. The objective of the study was to investigate the dose-dependent effects of novel enzymatically-synthesized 3′-sialyllactose (3′SL) sodium salt supplemented to swine milk replacer on growth, hematological parameters and tissue histology in a pre-clinical neonatal pig model. Forty-five two-day-old male and female pigs were provided one of four experimental diets for 21 days. Diets were formulated to contain 0 (CON), 140 (LOW), 200 (MOD) or 500 (HIGH) mg/L of 3′SL sodium salt. Samples were collected on days 8 and 22 of the study for hematological and histological analyses. The addition of 3′SL sodium salt to formula at all doses was well-tolerated by neonatal piglets and supported growth and development comparable to those observed in the CON group. In addition, serum chemistries as well as hematology and organ microscopic structure were unaffected by 3′SL (p > 0.05). These data provide supportive evidence for the safety of supplementation of this enzymatically-synthesized 3′SL sodium salt to human infant formula.