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BMC Pediatr. 2018 Feb 13;18(1):59. doi: 10.1186/s12887-018-1046-6.

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

Author information

1
Fondazione I.R.C.C.S. Ca Granda Ospedale Maggiore Policlinico, Neonatal Intensive Care Unit Department of Clinical Science and Community Health, University of Milan, Milan, Italy. nadia.liotto@policlinico.mi.it.
2
Centro di Nutrizione a Partenza neonatale, Clinica Mangiagalli, Via Della Commenda, 12, 20122, Milan, Italy. nadia.liotto@policlinico.mi.it.
3
Fondazione I.R.C.C.S. Ca Granda Ospedale Maggiore Policlinico, Neonatal Intensive Care Unit Department of Clinical Science and Community Health, University of Milan, Milan, Italy.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

TRIAL REGISTRATION:

The present study was retrospectively registered in ClinicalTrials.gov (trial number: NCT03035721 on January 18, 2017).

KEYWORDS:

Body composition; Full-term infants; Growth; Low-protein formula; Safety

PMID:
29439736
PMCID:
PMC5812222
DOI:
10.1186/s12887-018-1046-6
[Indexed for MEDLINE]
Free PMC Article

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