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Infant Formula with Added Bovine Milk Fat Globule Membrane and Modified Iron Supports Growth and Normal Iron Status
James Hedrick1, Michael Yeiser2, Cheryl L Harris3
1Kentucky Pediatrics, 201 South 5th Street, Bardstown, KY 40004, USA.
Insights
Adding bovine milk fat globule membrane (bMFGM) to infant formula supports healthy growth and iron status in infants. This study found no significant differences in growth or iron markers between formulas with and without bMFGM.
Area of Science:
- Pediatrics
- Nutrition Science
- Biochemistry
Background:
- Bovine milk fat globule membrane (bMFGM) components are hypothesized to support infant brain development.
- Infant formulas (IFs) are evolving to better mimic human milk composition.
- The role of bMFGM in infant nutrition requires further investigation.
Purpose of the Study:
- To evaluate the impact of added bMFGM and modified nutrient profiles in infant formula on infant growth, tolerance, and iron status.
- To compare a novel infant formula containing bMFGM with a standard formula.
- To assess safety and efficacy markers throughout the first year of life.
Main Methods:
- A double-blind, prospective trial randomized healthy term infants to receive either a control or an investigational infant formula (INV-MFGM) containing bMFGM.
- Formulas differed in protein, iron, arachidonic acid (ARA), and bMFGM content.
- Growth, tolerance (stool, fussiness, gassiness), and iron status (hemoglobin, hematocrit) were monitored up to 365 days.
Main Results:
- No significant differences were observed in the primary outcome of weight gain rate between 14-120 days of age.
- Growth, tolerance indicators, and study completion rates were similar between the control and INV-MFGM groups.
- Iron status markers, including hemoglobin and hematocrit, and incidence of anemia at one year of age showed no group differences.
Conclusions:
- Infant formula supplemented with bMFGM, modified protein, iron, and ARA is well-tolerated in healthy term infants.
- This formula supports adequate growth throughout the first year of life.
- The inclusion of bMFGM in infant formula supports normal iron status at one year of age.
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.
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