Added bovine milk fat globule membrane in formula: Growth, body composition, and safety through age 2: An RCT

•Adding bovine milk fat globule membrane (bMFGM) to infant formula may improve its composition.•This was the first randomized clinical trial to assess growth, body composition, and safety through 24 mo of age in infants who received added bMFGM in formula to 12 mo of age.•Formula with added bMFGM was safe and supported typical growth indices (including body weight, length, and head circumference) through 24 mo of age.•Formula-fed infants grew faster than human milk–fed infants between 6 and 24 mo of age.•Body composition data provided complementary evidence to support typical growth through 24 mo of age among infants who received formula feeding through 12 mo of age (with or without added bMFGM). The aim of this study was to assess the effects of an experimental formula (EF) with added whey protein-lipid concentrate (5 g/L; source of bovine milk fat globule membrane [bMFGM]) on growth, body composition, and safety through 24 mo of age in term infants. This was a double-blinded, randomized controlled trial conducted in Santiago, Chile. Infants were enrolled before 120 d and randomized to receive standard cow's milk-based formula (SF) or EF through the first year of life. Breastfed infants were the reference (HM). Growth (weight-for-age [WAZ], length-for-age [LAZ], BMI-for-age [BAZ], headcircumference-for-age [HCZ] z-scores); body composition (fat mass [FM] and fat-free mass, percentage body fat [%BF]); and adverse events through day 730 were recorded. Outcome trajectories were analyzed using a single generalized estimating equation testing the interaction between group and visit. We recruited 582 infants (HM = 235; SF = 174; EF = 173); 478 (>80%) completed the study. At baseline, only WAZ was different between the formula groups (0.14 lower in EF versus SF group, P = 0.035). WAZ, LAZ, and BAZ trajectories were higher from baseline to days 365 and 730 in EF or SF compared with HM (all P < 0.05). No differences in changes in body composition were observed between the formula groups. For EF versus HM, %BF was lower at day 180; however, this difference reversed from day 365. Fat-free mass was higher in formula groups compared with HM at all time points. No group difference in adverse event incidence rate was detected. During the first 2 y of life, infant formula with added bMFGM supports typical growth and safety compared with a standard formula.