Micronutrient and Glucose-Related Biomarkers Until 24 Mo of Age in Infants Receiving Formula With Added Bovine Milk Fat Globule Membrane Through the First Year of Life: An RCT

Abstract Objectives Bovine milk fat globule membrane (bMFGM) added in routine infant formula supports normal growth and safety through 24 mo of age in term infants. The impact on micronutrients and glucose-related biomarkers is assessed here. Methods In this double-blind, randomized, controlled trial, formula-fed infants were enrolled (<120 days of age) and randomized to receive a standard cow´s milk-based infant formula (SF, n = 174) or a similar formula with added whey protein-lipid concentrate (5 g/L; bMFGM; EF n = 173); exclusively breastfed infants were enrolled as a reference (HM, n = 235). In 50% of infants (chosen at random), parents agreed to blood collection (2–4 h fasting) at baseline, 6, 12, and 24 mo of age. Serum micronutrients (zinc, iron, ferritin, transferrin receptor) and glucose-related biomarkers (glucose, insulin, HOMA-IR [Homeostatic Model Assessment-Insulin Resistance], IGF-1) were analyzed. Results At baseline, significant differences in markers of iron status (serum iron, ferritin) and glucose-related biomarkers (glucose, HOMA-IR, and IGF-1) were detected between HM and study formula groups. At 6 and 12 mo, no differences in any measure were detected between study formula groups. Serum iron and ferritin at 12 mo as well as glucose-related biomarkers at 6 mo (insulin, HOMA-IR, IGF-1) and 12 mo (IGF-1 only) were lower in the HM vs study formula groups. By 24 mo, micronutrients and glucose-related biomarkers were similar between study formula groups (with the exception of significantly lower serum iron in the SF group); for HM vs study formula groups, differences included significantly lower zinc and IGF-1. Conclusions Patterns of micronutrients and glucose-related biomarkers were similar through two years of age in infants who received formula through one year. This study add to the body of data available for glucose-related biomarkers in children at two years of age and younger. Funding Sources The study was funded by Mead Johnson Nutrition (MJN). TMP, SSW, and JLW are currently, and CLB was previously employed by MJN.