Abstract
ABSTRACTBackgroundLipid 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.ObjectivesThis 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.MethodsFully 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.ResultsEquivalence 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.ConclusionsAn 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.
Highlights
Exclusive human milk is the preferred feeding for infants and provides a complete supply of nutrients to support growth and development in early life
Mean ± SD vitamin E levels were not apparently different in infants of both infant milk formulas (IMFs) groups (32.29 ± 6.27 μmol/L for Concept IMF and 32.73 ± 6.46 μmol/L for Control IMF; P = 0.62 TT) and all subjects of both formula-fed and breastfed groups had values within the adequate range (11– 50 μmol/L). This double-blind, randomized, controlled trial evaluated a concept IMF with lipid droplets that are large, milk phospholipid– coated, and contain dairy lipids (48%), features that are inspired by the large, triple-layer membrane–enveloped lipid droplets in human milk [12]
We observed an equivalent daily weight gain for infants fed the Concept IMF compared with those fed a standard IMF up to 17 wk of age despite a slightly lower formula intake at 13 and 17 wk of age in the Concept IMF group compared with the standard IMF group
Summary
Exclusive human milk is the preferred feeding for infants and provides a complete supply of nutrients to support growth and development in early life. 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. 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.
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