Infant Formula with Added Bovine Milk Fat Globule Membrane and Modified Iron Supports Growth and Normal Iron Status at One Year of Age: A Randomized Controlled Trial

Abstract

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.

Beyond ingredients: Supramolecular structure of lipid droplets in infant formula affects metabolic and brain function in mouse models

“…The clinical growth equivalence and tolerance studies published to date show that MGFM, as an ingredient, can be safely added to IF, yet there is no evidence that the mere presence of MFGM in IF modulates infant growth trajectories or has a protective effect against overweight or metabolic disturbances. Several studies show similar growth patterns, both weight and height, at 4, 6, 12 and 18 months (58–60, 62–64). In addition, some studies show differences in plasma cholesterol and plasma and erythrocyte polar lipids between experimental and control IF, but these differences were no longer observed at 12 months (65).…”

Beyond ingredients: Supramolecular structure of lipid droplets in infant formula affects metabolic and brain function in mouse models

“…The clinical growth equivalence and tolerance studies published to date show that MGFM, as an ingredient, can be safely added to IF, yet there is no evidence that the mere presence of MFGM in IF modulates infant growth trajectories or has a protective effect against overweight or metabolic disturbances. Several studies show similar growth patterns, both weight and height, at 4, 6, 12 and 18 months [ 64 – 66 , 68 – 70 ]. In addition, some studies show differences in plasma cholesterol and plasma and erythrocyte polar lipids between experimental and control IF, but these differences were no longer observed at 12 months [ 71 ].…”

Brain–immune–gut benefits with early life supplementation of milk fat globule membrane

“…Therefore, it would not be amiss to consider MFGM supplementation in children in addition to more “traditional” nutrients such as docosahexaenoic acid (DHA) and arachidonic acid (ARA), to ensure the best possible conditions for wholesome childhood development. In healthy term infants, MFGM supplementation, in addition to protein, iron, and ARA, was well tolerated, associated with adequate growth throughout the first year of life, and supported normal iron status at 1 year of age 47 …”

“…In healthy term infants, MFGM supplementation, in addition to protein, iron, and ARA, was well tolerated, associated with adequate growth throughout the first year of life, and supported normal iron status at 1 year of age. 47 What are the evidence gaps and suggestions for future clinical research?. Available efficacy and safety data show a tendency of MFGM supplementation to improve cognitive scores and immunity (Table 3).…”

“…In healthy term infants, MFGM supplementation, in addition to protein, iron, and ARA, was well tolerated, associated with adequate growth throughout the first year of life, and supported normal iron status at 1 year of age. 47 …”