title: Safety and tolerance evaluation of milk fat globule membrane-enriched infant formulas: a randomized controlled multicenter non-inferiority trial in healthy term infants.
abstract: OBJECTIVE
  This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions.
  
  
  METHODS
  Healthy, full-term infants (n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: -3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated.
  
  
  RESULTS
  Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]).
  
  
  CONCLUSIONS
  Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group.
authors.affiliation: Nutrition and Neonatologie, CIC 005 Peditrique INSERM, CHU Bordeaux, Bordeaux, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Billeaud
authors.affiliation: Università degli Studi di Palermo, Dipartimento Materno Infantile, Palermo, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Puccio
authors.affiliation: Hôpital Clocheville, CHU de Tours, Tours, France.
authors.forename: Elie
authors.initials: E
authors.lastname: Saliba
authors.affiliation: Hôpital Clemenceau, CHU de Caen, Caen, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Guillois
authors.affiliation: ITERG Bordeaux University, Bordeaux, France.
authors.forename: Carole
authors.initials: C
authors.lastname: Vaysse
authors.affiliation: Nestlé Clinical Development Unit, Nestec Ltd, Vevey, Switzerland.
authors.forename: Sophie
authors.initials: S
authors.lastname: Pecquet
authors.affiliation: Nestlé Clinical Development Unit, Nestec Ltd, Vevey, Switzerland.
authors.forename: Philippe
authors.initials: P
authors.lastname: Steenhout
keywords: formula tolerance; growth; infant feeding; milk fat globule membrane; safety