Neurodevelopment, nutrition, and growth until 12 mo of age in infants fed a low-energy, low-protein formula supplemented with bovine milk fat globule membranes: a randomized controlled trial.

Randomized controlled trial in Sweden among healthy term infants 37 to 42 weeks' gestation, birth weight 2500 to 4500 g, and age 2 months or younger at inclusion. The formula-fed infants were randomized 1:1; 80 were randomized to the MFGM-supplemented formula arm and 80 to standard formula, with a breastfed reference group used for comparison.

Infants in the experimental arm received a powdered low-energy, low-protein formula supplemented with bovine milk fat globule membrane (MFGM) fraction Lacprodan MFGM-10, fed orally from enrollment before 2 months of age until 6 months of age. The EF formula provided 60 kcal/100 mL and 1.20 g protein/100 mL; MFGM proteins made up 4% (wt:wt) of total protein. The comparator was a standard formula with 66 kcal/100 mL and 1.27 g protein/100 mL.

The MFGM-supplemented formula improved cognitive performance at 12 months compared with standard formula and brought scores close to those seen in breastfed infants. On Bayley-III, the EF group scored 105.8 6 9.2 versus 101.8 6 8.0 in the SF group, a 4.0-point higher score (95% CI: 1.1, 7.0; P = 0.008); the breastfed reference group scored 106.4 6 9.5, which was not different from EF (P = 0.73). There were no significant differences in linear growth, weight gain, BMI, percentage body fat, or head circumference between the two formula groups. Infants in the EF group consumed more formula (864 6 174 mL/d vs 797 6 165 mL/d; P = 0.022), suggesting compensation for the lower energy density, while total energy and protein intakes were similar.

The trial was relatively small and conducted in a single Swedish center, which limits generalizability. Follow-up was short, ending at 12 months, and six participants dropped out because of gastrointestinal symptoms. The intervention also changed formula energy and protein content along with MFGM supplementation, so the specific effect of MFGM cannot be fully isolated.