Added bovine milk fat globule membrane in formula: growth, body composition, and safety through age 2: an RCT.

Objective. The aim of this study was to assess the effects of an experimental formula (EF) with added whey protein-lipid concentrate (5g/L; source of bovine milk fat globule membrane [bMFGM]) on growth, body composition, and safety through 24mo of age in term infants. Methods. 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. Results. We recruited 582 infants (HM = 235; SF = 174; EF = 173); 478 (>80%) completed the study....