scholarly journals Safety and Tolerance Evaluation of Milk Fat Globule Membrane-Enriched Infant Formulas: A Randomized Controlled Multicenter Non-Inferiority Trial in Healthy Term Infants

2014 ◽  
Vol 8 ◽  
pp. CMPed.S16962 ◽  
Author(s):  
Claude Billeaud ◽  
Giuseppe Puccio ◽  
Elie Saliba ◽  
Bernard Guillois ◽  
Carole Vaysse ◽  
...  

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.

2020 ◽  
Vol 98 (Supplement_4) ◽  
pp. 68-68
Author(s):  
Sharon Donovan ◽  
Ryan N Dilger

Abstract The milk fat globule membrane (MFGM) is instrumental for the fat delivery system into human and bovine milk, but is typically removed during the manufacture of infant formula. MFGM contains components that may impact neurodevelopment, including sialic acid, gangliosides, sphingomyelin, choline, glycerophospholipids, proteins, and cholesterol. This presentation will review the clinical trial evidence linking MFGM supplementation to beneficial outcomes in infants and will describe potential mechanistic evidence linking MFGM with neurocognitive outcomes arising from preclinical studies in piglets. Infants fed formula supplemented with a MFGM (4% total protein) from 2 to 6 months of age had improved neurocognitive development at 1 year of age compared to infants fed standard formula. Infants fed formula with MFGM (5.0 g/L) and lactoferrin (0.6 g/L) for 1 year had an accelerated neurodevelopmental profile at 1 year and improved language subcategories at 18 months compared to infants fed a standard formula. To investigate potential mechanisms, piglets were fed a CONT formula or a TEST formula with MFGM and lactoferrin at the same concentrations from 2 to 31 days of age. Piglets underwent spatial T-maze testing to assess learning and memory, and magnetic resonance imaging to measure brain micro- and macrostructure. TEST piglets had lower radial and mean diffusivities in the internal capsule, suggesting greater myelination. The internal capsule contains motor and sensory projections from the cortex to corticospinal tract. Piglets on the CONT diet displayed shorter latency to choice in the T-maze compared to TEST piglets, potentially indicating anxiety-like behaviors or greater impulsivity. Aspects of the microbiome-gut-brain-axis (MGBA) were investigated to uncover potential mechanisms. TEST piglets had higher protein abundance of tyrosine hydroxylase and vasoactive intestinal peptide, longer villi and greater disaccharidase activity in the small intestine and differences in microbial abundances in the ascending colon and feces, suggesting potential modulation of the MGBA by MFGM.


1994 ◽  
Vol 1199 (1) ◽  
pp. 87-95 ◽  
Author(s):  
Naohito Aoki ◽  
Hidenori Kuroda ◽  
Miho Urabe ◽  
Yoshimi Taniguchi ◽  
Takahiro Adachi ◽  
...  

2002 ◽  
Vol 69 (4) ◽  
pp. 555-567 ◽  
Author(s):  
SUNG JE LEE ◽  
JOHN W. SHERBON

The effects of heat treatment and homogenization of whole milk on chemical changes in the milk fat globule membrane (MFGM) were investigated. Heating at 80 °C for 3–18 min caused an incorporation of whey proteins, especially β-lactoglobulin (β-lg), into MFGM, thus increasing the protein content of the membrane and decreasing the lipid. SDS-PAGE showed that membrane glycoproteins, such as PAS-6 and PAS-7, had disappeared or were weakly stained in the gel due to heating of the milk. Heating also decreased free sulphydryl (SH) groups in the MFGM and increased disulphide (SS) groups, suggesting that incorporation of β-lg might be due to association with membrane proteins via disulphide bonds. In contrast, homogenization caused an adsorption of caseins to the MFGM but no binding of whey proteins to the MFGM without heating. Binding of caseins and whey proteins and loss of membrane proteins were not significantly different between milk samples that were homogenized before and after heating. Viscosity of whole milk was increased when milk was treated with both homogenization and heating.


1977 ◽  
Vol 44 (3) ◽  
pp. 495-507 ◽  
Author(s):  
J. C. Allen ◽  
Catherine Humphries

SummaryBovine milk-fat globule membrane was solubilized with a zwitterionic surfactant and subjected to chromatography on agarose, with the surfactant in the eluant. Fractions were tested for their effects on the oxidation of buffered linoleate. The maximum oxidative capability was greatly enhanced by the addition of Cu, and became associated with the phospholipids.Further chromatography of the retarded protein peak from agarose on Sephadex G-200, again in the presence of surfactant, gave 2 protein peaks. Oxidative effectiveness resided almost entirely in the first peak, which was devoid of phospholipid, but high in xanthine oxidase activity. This fraction was subjected to isoelectric focusing, and the xanthine oxidase from this was highly pro-oxidative. Furthermore, its oxidative capability was almost doubled on heat treatment.


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