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Randomized Controlled Trial
. 2021 Dec 18;13(12):4541.
doi: 10.3390/nu13124541.

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

James Hedrick  1 , Michael Yeiser  2 , Cheryl L Harris  3 , Jennifer L Wampler  3 , Hila Elisha London  3 , Ashley C Patterson  3 , Steven S Wu  3
Affiliations
Randomized Controlled Trial

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

James Hedrick et al. Nutrients. .

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.

Keywords: growth; infant feeding; infant formula; iron status; milk fat globule membrane.

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Conflict of interest statement

The authors J.H. and M.Y. were provided funding in order to independently enroll study participants. C.L.H., E.L., J.L.W., A.C.P. and S.S.W. are employees of Reckitt|MJNI and had a role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the decision to publish the results.

Figures

Figure 1
Figure 1
Flow of study participants.
Figure 2
Figure 2
Mean achieved weight for male participants with World Health Organization (WHO) reference percentiles (2nd to 98th) through 12 months (days 14 to 365) of age. Control, red diamonds; INV-MFGM, blue circles. No statistically significant group differences by two-tailed ANOVA test.
Figure 3
Figure 3
Mean achieved weight for female participants with World Health Organization (WHO) reference percentiles (2nd to 98th) through 12 months (days 14 to 365) of age. Control, red diamonds; INV-MFGM, blue circles. * Denotes significant group difference, p < 0.05, two-tailed ANOVA test.
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