An infant formula with large, milk phospholipid–coated lipid droplets containing a mixture of dairy and vegetable lipids supports adequate growth and is well tolerated in healthy, term infants

Abstract

Background Lipid droplets in human milk have a mode diameter of ∼4 μm and are surrounded by a native phospholipid-rich membrane. Current infant milk formulas (IMFs) contain small lipid droplets (mode diameter ∼0.5 μm) primarily coated by proteins. A concept IMF was developed mimicking more closely the structure and composition of human milk lipid droplets. Objectives This randomized, controlled, double-blind equivalence trial evaluates the safety and tolerance of a concept IMF with large, milk phospholipid–coated lipid droplets (mode diameter 3–5 μm) containing vegetable and dairy lipids in healthy, term infants. Methods Fully formula-fed infants were enrolled up to 35 d of age and randomly assigned to 1 of 2 formulas until 17 wk of age: 1) Control IMF with small lipid droplets containing vegetable oils (n = 108); or 2) Concept IMF with large, milk phospholipid–coated lipid droplets comprised of 48% dairy lipids (n = 115). A group of 88 breastfed infants served as reference. Primary outcome was daily weight gain during intervention. Additionally, number and type of adverse events, growth, and tolerance parameters were monitored. Results Equivalence of daily weight gain was demonstrated (Concept compared with Control IMF: −1.37 g/d; 90% CI: −2.71, −0.02; equivalence margin ± 3 g/d). No relevant group differences were observed in growth, tolerance and number, severity, or relatedness of adverse events. We did observe a higher prevalence of watery stools in the Concept than in the Control IMF group between 5 and 12 wk of age (P < 0.001), closer to the stool characteristics observed in the breastfed group. Conclusions An infant formula with large, milk phospholipid–coated lipid droplets containing dairy lipids is safe, well tolerated, and supports an adequate growth in healthy infants. This trial was registered in the Dutch Trial Register (www.trialregister.nl) as NTR3683.

An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial

“…In line with previous findings [ 7 , 32 , 33 ], the most common types of (serious) adverse events reported in this study are gastro-intestinal disorders and infections. Strict and detailed safety evaluation did not reveal any clinically relevant differences in the frequency, type or severity of (serious) adverse events between formula groups.…”

Nutritional programming in early life: the role of dietary lipid quality for future health

“…However, our present studies suggest that we can further improve IMF lipid quality beyond FA composition by adjusting the lipid structure. This infant formula, containing large, PL-coated lipid droplets (Nuturis ® , Gallier et al, 2015) supports equivalent growth in term born infants (Breij et al, 2019), and further clinical studies testing growth-and other developmental outcomes are ongoing.…”

Lipid Composition, Digestion, and Absorption Differences among Neonatal Feeding Strategies: Potential Implications for Intestinal Inflammation in Preterm Infants

“…In contrast, MFGs of bovine-based formula are typically surrounded by a thick layer of casein and whey proteins, with PC and limited PE from soybean lecithin added as stabilizers [ 20 , 21 ] after the original MFGM is lost through processing [ 22 ]. These structural differences in MFG configuration largely derive from the manufacturing processes associated with formula production, particularly homogenization, which renders uniformly sized MFGs of bovine-, goat-, or soy-based formula significantly smaller than the average diameter of MFGs found in HM [ 13 , 23 , 24 ]. Furthermore, aggregates of denatured milk proteins, a consequence of preventative microbiological heat treatment, often occur at the surface of bovine-based formula MFGs [ 21 ].…”