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Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well
Jacques Rigo1, Stefanie Schoen2, Marc Verghote3
1Department of Pediatrics, Neonatal Unit, University of Liege, CHU-CHR Citadelle, Boulevard du XIIème de Ligne 1, 4000 Liege, Belgium.
Insights
Partially hydrolyzed infant formulas with varying protein levels support adequate growth and are safe for healthy infants. These formulas demonstrated good tolerance and safety profiles in the study population.
Area of Science:
- Nutrition Science
- Pediatric Health
- Infant Nutrition
Background:
- Partially hydrolyzed infant formulas (pHF) are designed for easier digestion.
- Optimal protein content in pHF for infant growth and tolerance requires further investigation.
- Ensuring adequate growth and safety is paramount for infant feeding interventions.
Purpose of the Study:
- To assess the growth, safety, and tolerance of partially hydrolyzed whey infant formulas with different protein concentrations.
- To compare the efficacy of pHF with 1.8 g, 2.0 g, and 2.27 g protein/100 kcal against WHO Child Growth Standards.
- To determine the equivalence of daily weight gain between different pHF protein levels.
Main Methods:
- Randomized controlled trial involving 207 healthy, full-term infants fed exclusively formula.
- Infants were assigned to receive pHF with 1.8 g (pHF1.8), 2.0 g (pHF2.0), or 2.27 g (pHF2.27) protein/100 kcal until 4 months of age.
- Primary outcome: equivalence in daily weight gain (± 3 g/day); secondary outcomes: comparison with WHO standards, gastrointestinal tolerance, and adverse events.
Main Results:
- Equivalence in daily weight gain was demonstrated between pHF1.8 and pHF2.27 (difference: -1.12 g/day).
- Equivalence was inconclusive between pHF2.0 and pHF2.27 (difference: -2.52 g/day).
- All groups exhibited adequate infant growth compared to WHO Child Growth Standards, with good gastrointestinal tolerance and safety.
Conclusions:
- Partially hydrolyzed infant formulas with varying protein content (1.8-2.27 g/100 kcal) support adequate growth in healthy infants.
- The evaluated pHF are safe and well-tolerated, indicating suitability for infant feeding.
- Further research may refine optimal protein levels for specific infant populations.
Abstract:
The current study aimed to investigate growth, safety and tolerance of partially hydrolysed infant formulae in healthy full-term infants. Fully formula-fed infants were randomised ≤14 days of age to receive a partially hydrolysed whey formula with 2.27 g protein/100 kcal (pHF2.27) or the same formula with 1.8 g or 2.0 g protein/100 kcal (pHF1.8 and pHF2.0) until 4 months of age. The primary outcome was equivalence in daily weight gain within margins of ± 3 g/day; comparison with WHO Child Growth Standards; gastrointestinal tolerance parameters and number of (serious) adverse events were secondary outcomes. A total of 207 infants were randomised, and 61 (pHF1.8), 46 (pHF2.0) and 48 (pHF2.27) infants completed the study per protocol. Equivalence in daily weight gain was demonstrated for the comparison of pHF1.8 and pHF2.27, i.e., the estimated difference was -1.12 g/day (90% CI: [-2.72; 0.47]) but was inconclusive for the comparisons of pHF2.0 and pHF2.27 with a difference of -2.52 g/day (90% CI: [-4.23; -0.81]). All groups showed adequate infant growth in comparison with the World Health Organization (WHO) Child Growth Standards. To conclude, the evaluated partially hydrolysed formulae varying in protein content support adequate growth and are safe and well tolerated in healthy infants.
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