Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth

Ahrens, Birgit; Hellmuth, Christian; Haiden, Nadja; Olbertz, Dirk; Hamelmann, Eckard; Vusurovic, Milica; Fleddermann, Manja; Roehle, Robert; Knoll, Anette; Koletzko, Berthold; Wahn, Ulrich; Beyer, Kirsten

doi:10.1097/mpg.0000000000001853

Cited by 14 publications

(36 citation statements)

References 40 publications

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“…Our findings are in line with previous studies from Ahrens et al [26] and Ziegler et al [27], indicating adequate growth in infants fed whey-based pHF with reduced protein content (1.9 g/100 kcal) in comparison with a control formula containing either 2.3 g/100 kcal protein [26] or 2.4 g/100 kcal [27]. Ahrens et al reported for the period between 28 and 112 days of age a median (IQR) daily weight gain of 28.5 (8.5) g/day for a formula without synbiotics and 28.9 (6.9) g/day for a formula with synbiotics.…”

Section: Discussionsupporting

confidence: 94%

Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants

et al. 2019

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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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Section: Discussionsupporting

confidence: 94%

Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants

et al. 2019

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“…The observed weight gain value for the PHF group in the current study is close to those reported in previous studies evaluating (partially) hydrolyzed formulas [ 7 , 17 , 26 , 27 ]. Previously, a randomized, clinical study of infants at risk for allergy showed that the weight development of infants consuming a whey-based partially hydrolyzed formula, which was quite similar to the PHF evaluated in the current study, was not significantly different during the first 18 months of life and only resulted in transiently higher length and head circumference values at 4 and 12 weeks compared to infants consuming a standard intact cow’s milk formula [ 7 ].…”

Section: Discussionsupporting

confidence: 90%

An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial

Picaud

Pajek²,

Arciszewska³

et al. 2020

Nutrients

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The current study evaluates the safety and tolerance of a partially hydrolyzed whey protein-based infant formula (PHF) versus an in intact cow’s milk protein formula (IPF). Breastfed infants were included as a reference group. In a multi-country, multicenter, randomized, double-blinded, controlled clinical trial, infants whose mothers intended to fully formula feed were randomized to PHF (n = 134) or IPF (n = 134) from ≤14 days to 17 weeks of age. The equivalence analysis of weight gain per day within margins of +/−3 g/d (primary outcome), the recorded adverse events, growth and gastro-intestinal tolerance parameters were considered for the safety evaluation. Equivalence of weight gain per day from enrolment until 17 weeks of age was demonstrated in the PHF group compared to the IPF group (difference in means −1.2 g/d; 90% CI (−2.42; 0.02)), with estimated means (SE) of 30.2 (0.5) g/d and 31.4 (0.5) g/d, respectively. No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups. A partially hydrolyzed whey protein-based infant formula supports adequate infant growth, with a daily weight gain equivalent to a standard intact protein-based formula; it is also safe for use and well-tolerated in healthy term infants.

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“…Of these, 180 were excluded through abstract screening, and a further 10 were excluded during full-text screening (analyzed bacteria in feces rather than metabolites ( n = 4); analyzed <3 metabolites ( n = 5); dietary exposure unclear ( n = 1)). Accordingly, a total of 24 articles were analyzed fully [ 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 ]. This scoping review focused on metabolomic analyses as opposed to individual and single biomarkers, therefore studies with fewer than three metabolites analyzed were excluded from further review.…”

Section: Methodsmentioning

confidence: 99%

Dietary Intake Influences Metabolites in Healthy Infants: A Scoping Review

et al. 2020

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Metabolites are generated from exogenous sources such as diet. This scoping review will summarize nascent metabolite literature and discriminating metabolites for formula vs. human- milk-fed infants. Using the PICOS framework (P—Patient, Problem or Population; I—Intervention; C—Comparison; O—Outcome; S—Study Design) and PRISMA item-reporting protocols, infants less than 12 months old, full-term, and previously healthy were included. Protocol was registered with Open Science Framework (OSF). Publications from 1 January 2009–2019 were selected, for various biofluids, study designs, and techniques (such as high-performance liquid chromatography (HPLC)). From 711 articles, blinded screening of 214 articles using Abstrackr® software, resulted in 24 for final review. Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines were adopted, which included a 24-point checklist. Articles were stratified according to biofluid. Of articles reporting discriminating metabolites between formula- and human milk-fed infants, 62.5% (5/8) of plasma/serum/dried blood spot, 88% (7/8) of urine and 100% (6/6) of feces related articles reported such discriminating metabolites. Overall, no differences were found between analytical approach used (targeted (n = 9) vs. un-targeted (n = 10)). Current articles are limited by small sample sizes and differing methodological approaches. Of the metabolites reviewed herein, fecal metabolites provided the greatest distinction between diets, which may be indicative of usefulness for future diet metabolite-focused work.

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Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth

Abstract: All tested hydrolyzed LP formulas allowed normal weight gain without being inferior to regular protein eHF in the first 4 months of life. This trial was registered at clinicaltrials.gov, NCT01143233.

Cited by 14 publications

References 40 publications

Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants

Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants

An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial

Dietary Intake Influences Metabolites in Healthy Infants: A Scoping Review

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