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

2015 ◽  
Vol 9 ◽  
pp. CMPed.S27185 ◽  
Author(s):  
Niklas Timby ◽  
Magnus Domellöf ◽  
Bo Lönnerdal ◽  
Olle Hernell
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.


PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0244916
Author(s):  
Benjamin B. Albert ◽  
José G. B. Derraik ◽  
Yin-Yin Xia ◽  
Tom Norris ◽  
Ting Zhang ◽  
...  

Background Gangliosides are a class of sphingolipids that are present in the cell membranes of vertebrates. Gangliosides influence a broad range of cellular processes through effects on signal transduction, being found abundantly in the brain, and having a role in neurodevelopment. Objective We aimed to assess the effects of maternal daily consumption of ganglioside-enriched milk vs non-enriched milk and a non-supplemented group of pregnant women on maternal ganglioside levels and pregnancy outcomes. Design Double-blind parallel randomized controlled trial. Methods 1,500 women aged 20–40 years were recruited in Chongqing (China) between 11 and 14 weeks of a singleton pregnancy, and randomized into three groups: Control–received standard powdered milk formulation (≥4 mg gangliosides/day); Complex milk lipid-enhanced (CML-E) group–same formulation enriched with complex milk lipids (≥8 mg gangliosides/day) from milk fat globule membrane; Reference–received no milk. Serum ganglioside levels were measured in a randomly selected subsample of 250 women per group. Results CML-E milk was associated with marginally greater total gangliosides levels in maternal serum compared to Control (13.02 vs 12.69 μg/ml; p = 0.034) but not to Reference group. CML-E milk did not affect cord blood ganglioside levels. Among the 1500 women, CML-E milk consumption was associated with a lower rate of gestational diabetes mellitus than control milk [relative risk 0.80 (95% CI 0.64, 0.99)], but which was not different to the Reference group. CML-E milk supplementation had no other effects on maternal or newborn health. Conclusions Maternal supplementation with milk fat globule membrane, as a source of gangliosides, was not associated with any adverse health outcomes, and did not increase serum gangliosides compared with the non-supplemented reference group. Trial registration Chinese Clinical Trial Register (ChiCTR-IOR-16007700). Clinical trial registration ChiCTR-IOR-16007700; www.chictr.org.cn/showprojen.aspx?proj=12972.


2019 ◽  
Vol 7 ◽  
Author(s):  
Xiaonan Li ◽  
Yongmei Peng ◽  
Zailing Li ◽  
Britt Christensen ◽  
Anne B. Heckmann ◽  
...  

2016 ◽  
Vol 61 ◽  
pp. 228-238 ◽  
Author(s):  
Lorena Claumarchirant ◽  
Antonio Cilla ◽  
Esther Matencio ◽  
Luis Manuel Sanchez-Siles ◽  
Pilar Castro-Gomez ◽  
...  

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4541
Author(s):  
James Hedrick ◽  
Michael Yeiser ◽  
Cheryl L. Harris ◽  
Jennifer L. Wampler ◽  
H. Elisha London ◽  
...  

Inclusion of bovine-derived milk fat globule membrane (bMFGM) or bMFGM components in infant formulas (IFs) may support healthy brain development. This double-blind, prospective trial evaluated growth, tolerance, and iron status in infants receiving added bMFGM and modified protein, iron, and arachidonic acid (ARA) concentrations in IF. Healthy term infants were randomized to: control (marketed, routine cow’s milk-based IF/100 kcal: 2.1 g protein, 1.8 mg iron, 34 mg ARA) or INV-MFGM (investigational cow’s milk-based IF/100 kcal: 1.9 g protein, 1.2 mg iron, 25 mg ARA and whey protein-lipid concentrate, 5 g/L (source of bMFGM)). Anthropometrics, stool characteristics, fussiness, and gassiness through day 365 and blood markers of iron status at day 365 were evaluated. The primary outcome was rate of weight gain from 14–120 days of age. Of 373 infants enrolled (control: 191, INV-MFGM: 182), 275 completed the study (control: 141; INV-MFGM: 134). No group differences in growth rate (g/day) from day 14–120 or study discontinuation were detected. Few group differences in growth or parent-reported fussiness, gassiness, or stool characteristics were detected. No group differences were detected in hemoglobin, hematocrit, or incidence of anemia. In healthy term infants, bMFGM and modified protein, iron, and ARA concentrations in a cow’s milk-based IF were well-tolerated, associated with adequate growth throughout the first year of life, and supported normal iron status at one year of age.


Dairy ◽  
2021 ◽  
Vol 2 (2) ◽  
pp. 202-217
Author(s):  
Michele Manoni ◽  
Donata Cattaneo ◽  
Sharon Mazzoleni ◽  
Carlotta Giromini ◽  
Antonella Baldi ◽  
...  

Milk lipids are composed of milk fat globules (MFGs) surrounded by the milk fat globule membrane (MFGM). MFGM protects MFGs from coalescence and enzymatic degradation. The milk lipid fraction is a “natural solvent” for macronutrients such as phospholipids, proteins and cholesterol, and micronutrients such as minerals and vitamins. The research focused largely on the polar lipids of MFGM, given their wide bioactive properties. In this review we discussed (i) the composition of MFGM proteome and its variations among species and phases of lactation and (ii) the micronutrient content of human and cow’s milk lipid fraction. The major MFGM proteins are shared among species, but the molecular function and protein expression of MFGM proteins vary among species and phases of lactation. The main minerals in the milk lipid fraction are iron, zinc, copper and calcium, whereas the major vitamins are vitamin A, β-carotene, riboflavin and α-tocopherol. The update and the combination of this knowledge could lead to the exploitation of the MFGM proteome and the milk lipid fraction at nutritional, biological or technological levels. An example is the design of innovative and value-added products, such as MFGM-supplemented infant formulas.


2021 ◽  
pp. 106378
Author(s):  
Iolly Tábata Oliveira Marques ◽  
Fábio Roger Vasconcelos ◽  
Juliana Paula Martins Alves ◽  
Assis Rubens Montenegro ◽  
César Carneiro Linhares Fernandes ◽  
...  

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