AI Article Synopsis
- Milk fat globule membrane (MFGM) is important for infant development but is not present in standard infant formulas; this study aimed to assess the safety of adding MFGM to formula for infants aged 0 to 12 months.
- In a trial involving 375 infants, those on MFGM-enriched formula experienced fewer instances of diarrhea and soft stools compared to those on standard formula, indicating better digestive tolerance.
- Overall, MFGM-enriched formula was found to be safe and well-tolerated, although breast-fed infants showed better growth and health outcomes compared to both formula-fed groups.
Article 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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9347101 | PMC |
| http://dx.doi.org/10.1186/s12887-022-03507-8 | DOI Listing |
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