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Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial.


ABSTRACT: A high early protein intake is associated with rapid postnatal weight gain and altered body composition. We aimed to evaluate the safety of a low-protein formula in healthy full-term infants.A randomized controlled trial was conducted. A total of 118 infants were randomized to receive two different protein content formulas (formula A or formula B (protein content: 1.2 vs. 1.7 g/100 mL, respectively)) for the first 4 months of life. Anthropometry and body composition by air displacement plethysmography were assessed at enrolment and at two and 4 months. The reference group comprised 50 healthy, exclusively breastfed, full-term infants.Weight gain (g/day) throughout the study was similar between the formula groups (32.5?±?6.1 vs. 32.8?±?6.8) and in the reference group (30.4?±?5.4). The formula groups showed similar body composition but a different fat-free mass content from breastfed infants at two and 4 months. However, the formula A group showed a fat-free mass increase more similar to that of the breastfed infants. The occurrence of gastrointestinal symptoms or adverse events was similar between the formula groups.Feeding a low-protein content formula appears to be safe and to promote adequate growth, although determination of the long-term effect on body composition requires further study.The present study was retrospectively registered in ClinicalTrials.gov (trial number: NCT03035721 on January 18, 2017).

SUBMITTER: Liotto N 

PROVIDER: S-EPMC5812222 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial.

Liotto Nadia N   Orsi Anna A   Menis Camilla C   Piemontese Pasqua P   Morlacchi Laura L   Condello Chiara Cristiana CC   Giannì Maria Lorella ML   Roggero Paola P   Mosca Fabio F  

BMC pediatrics 20180213 1


<h4>Background</h4>A high early protein intake is associated with rapid postnatal weight gain and altered body composition. We aimed to evaluate the safety of a low-protein formula in healthy full-term infants.<h4>Methods</h4>A randomized controlled trial was conducted. A total of 118 infants were randomized to receive two different protein content formulas (formula A or formula B (protein content: 1.2 vs. 1.7 g/100 mL, respectively)) for the first 4 months of life. Anthropometry and body compos  ...[more]

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