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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.

Author information

1
Nutrition and Neonatologie, CIC 005 Peditrique INSERM, CHU Bordeaux, Bordeaux, France.
2
Università degli Studi di Palermo, Dipartimento Materno Infantile, Palermo, Italy.
3
Hôpital Clocheville, CHU de Tours, Tours, France.
4
Hôpital Clemenceau, CHU de Caen, Caen, France.
5
ITERG Bordeaux University, Bordeaux, France.
6
Nestlé Clinical Development Unit, Nestec Ltd, Vevey, Switzerland.

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%]).

CONCLUSION:

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.

KEYWORDS:

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

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