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Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized
Nadia Liotto1,2, Anna Orsi3, Camilla Menis3
1Fondazione 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.
Insights
A low-protein infant formula is safe and supports adequate growth. Further research is needed to understand its long-term effects on infant body composition.
Area of Science:
- Pediatrics
- Nutrition Science
- Infant Health
Background:
- High early protein intake in infants is linked to rapid weight gain and altered body composition.
- The safety of low-protein formulas for healthy, full-term infants requires evaluation.
Purpose of the Study:
- To assess the safety and growth outcomes of a low-protein infant formula.
- To compare body composition in infants fed low-protein formula versus breast milk.
Main Methods:
- A randomized controlled trial involving 118 infants fed one of two formulas (1.2 vs. 1.7 g/100 mL protein) for 4 months.
- Anthropometry and body composition (air displacement plethysmography) were measured at enrollment, 2 months, and 4 months.
- A reference group of 50 exclusively breastfed infants was included for comparison.
Main Results:
- Weight gain was similar across all groups (low-protein formula groups and breastfed reference group).
- Infants fed formula had similar body composition, but differed in fat-free mass compared to breastfed infants at 2 and 4 months.
- Formula A (lower protein) showed a fat-free mass increase closer to that of breastfed infants; adverse events were similar between formula groups.
Conclusions:
- Low-protein infant formula appears safe and supports appropriate infant growth.
- Long-term effects of low-protein formula on body composition warrant additional investigation.
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).
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