Trial reportBMC pediatrics2022
Safety and tolerance assessment of milk fat globule membrane-enriched infant formulas in healthy term Chinese infants: a randomised multicenter controlled trial.
Trial report in BMC pediatrics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 18 citations in OpenAlex.
- Effects of an infant formula containing a whey protein concentrate on feeding tolerance and markers of intestinal immune defense in Chinese infants.BMC nutrition · 2026Article
- Milk Fat Globule Membrane: Structural Organization, Bioactive Constituents, and Therapeutic Applications.Foods (Basel, Switzerland) · 2026Review
- Milk fat globule membrane in early-life nutrition: composition, production, and biological effects on infant immune maturation, intestinal development, neurocognitive function, and growth.Frontiers in nutrition · 2026Review
- Functional Significance of Probiotic Bacterial Interactions with Milk Fat Globules in a Human Host.Microorganisms · 2025Review
- Modifying physicochemical properties, rheology, and creaming stability of milk fat globule and membrane through ultrasound treatment.Ultrasonics sonochemistry · 2024Article
- Article
- Tolerance of Infants Fed a Hydrolyzed Rice Infant Formula with 2'-Fucosyllactose (2'-FL) Human Milk Oligosaccharide (HMO).Nutrients · 2024Article
- Milk Fat Globule Membranes for Mental Health across the Human Lifespan.Foods (Basel, Switzerland) · 2024Review
- Supplemented Infant Formula and Human Breast Milk Show Similar Patterns in Modulating Infant Microbiota Composition and Function In Vitro.International journal of molecular sciences · 2024Article
- Comparative study of interfacial properties and thermal behaviour of milk fat globules and membrane prepared from ultrasonicated bovine milk.Ultrasonics sonochemistry · 2024Article
- Beyond ingredients: Supramolecular structure of lipid droplets in infant formula affects metabolic and brain function in mouse models.PloS one · 2023Article
- The Immunological Role of Milk Fat Globule Membrane.Nutrients · 2022Review
- Milk Fat Globules: 2024 Updates.Newborn (Clarksville, Md.)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMilk fat globule membrane (MFGM), natural to breast milk, is essential for neonatal development, but lacking from standard infant formulas.
objectivesTo evaluate the safety and tolerability of MFGM supplementation in formula for infants 0 to 12 months.
methodsIn 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.
resultsInfants (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).
conclusionsMFGM-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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