A safety evaluation of mixed human milk oligosaccharides in neonatal farm piglets

Abstract

Human Milk Oligosaccharides (HMOs) are the third most abundant, solid component of human milk after lactose and fat. As novel processes are developed to cost-effectively produce commercial volumes of these oligosaccharides, they are becoming more common components of infant formulas worldwide. The study evaluated the safety of a novel mixture of HMOs in a neonatal piglet model with the objective of identifying potential effects during the sensitive, preweaning developmental stage of life. The mixture of HMOs (HMO MIX 1) was composed of 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), lacto-N-tetraose (LNT), 3′-sialyllactose (3′-SL), and 6′-sialyllactose (6′-SL), and was administered to 2-day old piglets at either 5.75 or 8.0 g/L for a period of 21 days. Piglets in the 5.75 and 8.0 g/L HMO MIX 1 dosing groups did not exhibit differences in body weight, food consumption, or feed efficiency. Analysis of clinical chemistry parameters on Study Day 7 and Study Day 21 did not demonstrate any effects that could be attributed to HMO MIX 1, nor were there any findings in organ weight, macroscopic, or microscopic inspection of tissues that could be attributed to this oligosaccharide blend. Therefore, since administration of HMO MIX 1 in a liquid diet up to 8.0 g/L resulted in no toxicologically-relevant effects in comparison with animals fed a control diet, this study supports the safety of this ingredient for addition to infant formula products.

Neonatal subchronic toxicity and in vitro genotoxicity studies of the human‐identical milk oligosaccharide 3‐fucosyllactose

“…These potential differences in the absorption, distribution, metabolism, and excretion of HMOs between adult and neonatal rats may have contributed to the changes in urinary parameters being observed in this and other neonatal rat 90‐day studies of HiMOs and oligofructose but not in studies of HiMOs using adult rats. Interestingly, there were no effects on urinalysis parameters when a mixture of 5 HiMOs (10.4% of which comprised 3‐FL) was administered in the diet to neonatal farm piglets for 21 days (Hanlon, 2020). This may suggest that age is not the only factor and that this could be a rat‐specific effect, and/or these differences may relate to the way in which the test article is administered (gradual daily consumption through the diet vs. gavage, which, as a bolus dose, is more representative of infant formula consumption); this represents an interesting area of future research.…”