Effect of Lower Versus Higher Protein Content in Infant Formula Through the First Year on Body Composition from 1 to 6 Years: Follow-Up of a Randomized Clinical Trial

ObjectiveThe objective of this study was to investigate the effect of lower protein (LP) versus higher protein (HP) content in infant formula on body composition from 3 months to 6 years. MethodsIn a multicenter, double-blind European trial, healthy infants (N=1,090) were randomly assigned to different protein content formulas (upper [HP] and lower [LP] limits of the European Union regulations in 2001) during the first year; breastfed infants (N=588) were recruited for reference values. Weight, height, and triceps and subscapular skinfold (SF) thickness were measured repeatedly (N=650 at 6 years), and body composition was estimated (Slaughter). The 99th percentile of fat mass index reference data were used to assess excess body fat at 6 years. ResultsAt 2 and 6 years, the study observed greater sum of SFs ( 2 years: 0.5 mm, P=0.026, 6 years: 0.6 mm, P=0.045), fat mass index ( 2 years: 0.12 kg/m(2), P=0.008, 6 years: 0.15 kg/m(2), P=0.011), and fat-free mass index ( 2 years: 0.17 kg/m(2), P=0.003, 6 years: 0.18 kg/m(2), P=0.010) in the HP group compared with the LP group. At 6 years, the HP group had a twofold higher risk than the LP group for excess body fat (adjusted odds ratio: 2.13, P=0.019). ConclusionsInfant formula with HP levels induced greater fat mass in children from 2 to 6 years. Lowering the protein content of infant formula may result in a healthier body composition in early childhood.