Safety and tolerance assessment of milk fat globule membrane-enriched infant formulas in healthy term Chinese infants: a randomised multicenter controlled trial

Abstract

Background Milk fat globule membrane (MFGM), natural to breast milk, is essential for neonatal development, but lacking from standard infant formulas. Objectives To evaluate the safety and tolerability of MFGM supplementation in formula for infants 0 to 12 months. Methods In a prospective, multicentre, double-blind, randomized trial, healthy term infants were randomized to a standard formula (SF, n = 104) or an MFGM-enriched formula (MF, n = 108) for 6 months and a corresponding follow-on formula until 12 months. Exclusively breast-fed infants (n = 206) were recruited as the reference group (BFR). Tolerance and safety events were recorded continuously. Anthropometric measurements were assessed at enrolment, 42 days and 4, 6, 8 and 12 months. Results Infants (n = 375) completed the study with average dropout of < 20%. Stool frequency, color, and consistency between SF and MF were not significantly different throughout, except the incidence of loose stools in MF at 6 months being lower than for SF (odds ratio 0.216, P < 0.05) and the frequency of green-colored stools at 12 months being higher in MF (CI 95%, odds ratio 8.92, P < 0.05). The BFR had a higher frequency of golden stools and lower rate of green stools (4–6 months) than the two formula-fed groups (P < 0.05). SF displayed more diarrhoea (4.8%) than MF (1%) and BFR (1%) at the 8-month visit (P < 0.05). BFR (0–1%) had significantly less (P < 0.05) lower respiratory infections than MF (4.6–6.5%) and SF (2.9–5.8%) at 6- and 8-months, respectively. Formula intake, frequency of spit-up/vomiting or poor sleep were similar between SF and MF. Growth rate (g/day) was similar at 4, 6, 8 and 12 months between the 3 groups, but growth rate for BFR was significantly higher than for SF and MF at 42 days (95% CI, P = 0.001). Conclusions MFGM-enriched formula was safe and well-tolerated in healthy term infants between 0 and 12 months, and total incidences of adverse events were similar to that for the SF group. A few differences in formula tolerance were observed, however these differences were not in any way related to poor growth.

Milk Fat Globules: 2024 Updates

“…116 In term infants, MFG membrane supplementation begun in the 1st week seems safe. 117 We still need to study preterm infants, who may possibly show greater benefit because of lower stores. HM and MFG membrane components may possibly protect against necrotizing enterocolitis, stunted brain growth, and brain injury, retinopathy of prematurity, and infections.…”

Milk Fat Globule Membranes for Mental Health across the Human Lifespan

“…The development of typical behavioural and emotional skills is a key feature of early life associated with rapid central nervous system development that underpins mood stability later in life. Breastmilk is the gold standard of infant nutrition and is rich in nutrients and MFGMs [ 76 ]. Fortification of infant formula aims to bring formula composition closer to that of breastmilk [ 77 , 78 ].…”

Beyond ingredients: Supramolecular structure of lipid droplets in infant formula affects metabolic and brain function in mouse models

“…modulates infant growth trajectories or has a protective effect against overweight or metabolic disturbances. Several studies show similar growth patterns, both weight and height, at 4, 6, 12 and 18 months [64][65][66][68][69][70]. In addition, some studies show differences in plasma cholesterol and plasma and erythrocyte polar lipids between experimental and control IF, but these differences were no longer observed at 12 months [71].…”