Effects of osteopontin-enriched formula on lymphocyte subsets in the first 6 months of life: a randomized controlled trial

Pediatr Res. 2017 Jul;82(1):63-71. doi: 10.1038/pr.2017.77. Epub 2017 May 24.


BackgroundHuman milk is rich in osteopontin (OPN), which has immunomodulatory functions.MethodsIn a randomized controlled trial, standard formula (SF) and the same formula with 65 mg of OPN/L (F65) or 130 mg of OPN/L (F130), representing ~50 and 100% of the OPN concentration in human milk, were compared. We examined frequencies and composition of peripheral blood immune cells by four-color immunoflow cytometry of formula-fed infants at ages 1, 4, and 6 months, and compared them with a breastfed (BF) reference group.ResultsThe F130 group had increased T-cell proportions compared with the SF (P=0.036, average effect size 0.51) and F65 groups (P=0.008, average effect size 0.65). Compared with the BF group, the monocyte proportions were increased in the F65 (P=0.001, average effect size 0.59) and F130 (P=0.006, average effect size 0.50) groups, but were comparable among the formula groups.ConclusionOPN in an infant formula at a concentration close to that of human milk increased the proportion of circulating T cells compared with both SF and formula with added OPN at ~50% of the concentration in human milk. This suggests that OPN may favorably influence immune ontogeny in infancy and that the effects appear to be dose-dependent.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Breast Feeding*
  • Female
  • Flow Cytometry
  • Humans
  • Immune System
  • Infant
  • Infant Formula / chemistry*
  • Infant, Newborn
  • Inflammation
  • Leukocytes / cytology
  • Lymphocyte Count
  • Lymphocyte Subsets / cytology*
  • Male
  • Milk, Human / chemistry
  • Monocytes / cytology
  • Osteopontin / administration & dosage*
  • Phenotype


  • Osteopontin