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Safety and efficacy of infant formula with protein content of 1.61 g/100 kcal for infants between 3 and 12 months

Posted:  Tuesday, August 30, 2016

A randomized controlled trial on adequacy of infant formula with protein content of 1.61 g/100 kcal for infants between 3 and 12 months

High amount of protein in infant formulas, although suitable during the first months of life, may result in unnecessary protein intake in older infants, making them susceptible to risk of obesity at later stages. The regulatory minimum limit of protein concentration in infant formulas in the European Union and the United States is 1.8 g/100 kcal. A study published in the Journal of Pediatric Gastroenterology and Nutrition aimed to investigate the adequacy of a formula with a protein content of 1.61 g/100 kcal in supporting the growth of infants after the age of 3 months.

In this study, 194 formula-fed infants less than 3 months of age were randomly assigned to either experimental formula (EXPL, 1.61 g protein/100 kcal) or control formula (CTRL, 2.15 g protein/100 kcal). In addition, 112 breastfed (BF) infants were assigned to the reference group. The infants were fed with the study formulas from 3 to 12 months. Small amounts of complementary foods were allowed from 4–6 months and unrestricted amounts were allowed after 6 months.

The study observed similar weight gain (g/day) from 3–6 months in both EXPL and CTRL groups. Longitudinal weight gain from 4–12 months was lower in EXPL than in CTRL group but higher than BF group. The EXPL group had fewer infants with weight >85th percentile compared to CTRL group, indicated by longitudinal analysis of odds ratios performed between 4 and 12 months. Compared to the CTRL group, the serum biochemical parameters of EXPL group were similar to that of BF infants.

The study concluded that a formula containing high-quality protein content of 1.61 g/100 kcal supports normal growth in children after the age of 3 months and is less likely to result in infants with weight >85th percentile compared to those fed with standard formula.

News Source: Ziegler E, Fields D, Chernausek S, et al. Adequacy of Infant Formula With Protein Content of 1.6 g/100 kcal for Infants Between 3 and 12 Months. Journal of Pediatric Gastroenterology and Nutrition. 2015;61(5):596-603.