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Clin Med Insights Pediatr. 2014 Nov 3;8:51-60. doi: 10.4137/CMPed.S16962. eCollection 2014.

Safety and tolerance evaluation of milk fat globule membrane-enriched infant formulas: a randomized controlled multicenter non-inferiority trial in healthy term infants.

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Nutrition and Neonatologie, CIC 005 Peditrique INSERM, CHU Bordeaux, Bordeaux, France.
Università degli Studi di Palermo, Dipartimento Materno Infantile, Palermo, Italy.
Hôpital Clocheville, CHU de Tours, Tours, France.
Hôpital Clemenceau, CHU de Caen, Caen, France.
ITERG Bordeaux University, Bordeaux, France.
Nestlé Clinical Development Unit, Nestec Ltd, Vevey, Switzerland.



This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions.


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.


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%]).


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.


formula tolerance; growth; infant feeding; milk fat globule membrane; safety

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