Cognitive gains: Mead Johnson-backed China RCT reveals benefits of adding bovine MFGM to infant formula
The improved formula was also associated with significantly reduced diarrhoea and respiratory-associated adverse events in the first two years.
An international group of researchers from China, USA, and Australia conducted a randomised clinical trial to evaluate the effects on neurodevelopment, growth, and health outcomes infants receiving MFGM and LF in their formula. The study was sponsored by Mead Johnson Nutrition.
They released the findings in The Journal of Pediatrics.
A total of 451 healthy infants were enrolled in this multicentre, double-blind, randomised, controlled, parallel group trial at three clinical sites in Fuyang, Anhui Province, China. They were between 10 to 14 days of age at enrolment.
The infants were divided into two groups, control (n=228) and treatment (n=223) and consumed the formulas for one year.
The control group was given a cow milk-based infant formula, while the treatment group was fed infant formula with added MFGM and LF (containing bovine milk fat globule membrane [bMFGM; whey protein-lipid concentrate, 5 g/L] and bovine lactoferrin [0.6 g/L]).
The infants were evaluated on cognitive and developments at 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age.
The primary outcome was the cognitive composition score at day 365, analysed using the Bayley Scales of Infant Development, Bayley-III, which evaluates cognitive, language and motor skills
The secondary outcomes of this study were tolerance measures, additional neurodevelopmental and language outcomes, growth, and medically confirmed adverse events.
After one year, infants in the MFGM + LF group achieved significant (p<0.001) higher cognitive composite score (111) than the control group (102.3).
In language and motor, MFGM + LF group also had a significantly (p<0.001) higher mean score (122.6, 118.3), compared to control group (110.3, 105.7).
The researchers said: “The MFGM + LF group demonstrated accelerated neurodevelopment by 12 months characterised in part by significantly longer attentional engagement and higher selected Bayley-III scores.”
Furthermore, the infants’ growths were not affected and those in the MFGM + LF group showed significantly fewer adverse gastrointestinal and respiratory-associated problems through to 18 months of age.
Specifically, incidence of upper respiratory tract infections, cough, and diarrhoea, were significantly lower (p<0.05).
Clinical evidence of lower incidence of diarrhea and otitis media in infants receiving dietary MFGM were also consistent with preclinical data supporting antipathogenic effects.
The researchers however acknowledged several limitations of the present study.
A breastfed reference group was not enrolled which could “certainly help to gauge the degree to which formula-fed infants approach optimal levels of outcome.”
Another limitation was the inability to distinguish between individual effects of MFGM and LF, “we note that a growing body of clinical evidence to date has demonstrated neurodevelopmental or behavioral effects of MFGM and its components, whereas clinical evidence for LF in these domains is absent,” they added.
MFGM is a complex protein–phospholipid trilayer that surrounds fat droplets secreted into milk. It is highly conserved across mammalian species.
Initial research supported MFGM as a bioactive component for digestive health, immune, and central nervous system development and function.
In conclusion, the addition of MFGM and LF in an infant formula was associated with a significantly accelerated neurodevelopmental profile, as well as lower incidence of gastrointestinal- and respiratory-associated adverse events through to 18 months of age.
Researchers suggested that, “Dietary bMFGM and bovine lactoferrin together may not only provide a better approximation of the bioactive composition of human milk, but also contribute to beneficial cognitive, gastrointestinal, and respiratory health outcomes.
“More data will certainly be needed to evaluate neurodevelopmental outcomes in older children to help establish how the nutritive effects of MFGM may be manifested longitudinally using a developmental systems approach.”
Source: The Journal of Pediatrics
“Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial”
Authors: Fei Li, et al.