Journal Article

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

Wu, Steven S., Patterson, Ashley C., Hedrick, James, Yeiser, Michael, London, Hila Elisha, Harris, Cheryl L., Wampler, Jennifer L.

2021

Overview

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.

• Publisher: MDPI AG,MDPI
• Subject: Age Factors / Anemia / anthropometric measurements / arachidonic acid / Babies / Baby foods / Birth weight / Blood / brain / Child Development - physiology / cows / Fatty acids / Female / Food, Fortified / Gestational age / Glycolipids - administration & dosage / Glycoproteins - administration & dosage / hematocrit / hemoglobin / Humans / Hypotheses / Infant / Infant Formula / infant formulas / Infant Nutritional Physiological Phenomena / Infant, Newborn / Ingredients / Iron / Iron - metabolism / Iron, Dietary - administration & dosage / Lipid Droplets / Male / Milk / milk fat / Oils & fats / Pediatrics / Proteins / randomized clinical trials / weight gain / whey