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

Rigo, Jacques; Schoen, Stefanie; Verghote, Marc; Overmeire, Bart Van; Marion, W F van; Abrahamse‐Berkeveld, Marieke; Alliët, Philippe

doi:10.3390/nu11071654

Cited by 13 publications

(15 citation statements)

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“…The voluntary blood sample obtained in a subgroup of infants at 17 weeks of age did not reveal any statistically significant differences between intervention groups. The serum urea levels are within normal ranges and the values for the subgroup of the PHF-fed infants observed in the current study (median of 18.0 mg/dL) are in line with previously reported values for 4-month-old infants consuming this PHF (median of 20.5 mg/dL) [ 19 ]. Interestingly, breastfed infants had lower serum urea levels and a lower body weight at four months of age compared to both formula groups, as reported previously [ 34 , 35 ], and this can be (partially) attributed to differences in protein quality and quantity [ 36 ].…”

Section: Discussionsupporting

confidence: 92%

“…In our study, a significantly lower body weight was observed at 8 and 13 weeks of age in the PHF (and the breastfed reference group) versus the IPF group, which was not paralleled by any statistically significant differences in length or head circumference outcomes. Confirming previous findings [ 19 ], we observed infant growth outcomes for the PHF group that were close to those of breastfed infants and to the WHO growth standard median, indicative of normal infant growth. In addition, as evident from the demonstrated equivalence in daily weight gain, length gain and head circumference gain in the randomized groups, the current study confirms the suitability and nutritional adequacy of this PHF in comparison to a standard IPF, following stringent evaluation according to regulatory guidelines [ 20 , 21 ].…”

Section: Discussionsupporting

confidence: 90%

“…Hence, as a first step, the nutritional adequacy and safety of (partially) hydrolyzed infant formulas need to be confirmed [ 1 , 18 ]. The aforementioned PHF, supplemented with specific prebiotic mixtures, was shown to support adequate growth according to the WHO growth standards, and it was found to be safe and well-tolerated in infants [ 7 , 19 ]. However, a more stringent, specifically designed clinical evaluation is required in order to confirm its safety and suitability, including a head-to-head comparison to a standard intact cow’s milk protein formula [ 20 , 21 ].…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

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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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“…Non-inferior weight gain was also shown in another trial of infants fed a pHF-W (1.9 g/100 kcal) vs. extensively hydrolyzed protein formula (2.3 g/100 kcal) ( 37 ). To our knowledge, only one previous study has assessed pHF-W formula with a protein level below this range; Rigo et al ( 38 ) showed that infants fed with pHF-W containing 1.8 g protein/100 kcal had equivalent weight gain from enrollment (≤14 days of age) to 4 months compared to infants fed pHF-W with 2.27 g protein/100 kcal.…”

Section: Introductionmentioning

confidence: 99%

A new partially hydrolyzed whey-based follow-on formula with age-adapted protein content supports healthy growth during the first year of life

Billeaud¹,

Adamon²,

Piloquet³

et al. 2022

Front. Pediatr.

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BackgroundStandard infant formulae often have higher protein content than breastmilk in order to compensate for potentially lower digestibility; excess protein intake may promote adverse effects later in life. A new partially hydrolyzed whey-based (pHF-W) follow-on formula (FoF) with age-adapted protein content was evaluated for growth and gastrointestinal (GI) tolerance in healthy infants.MethodsFormula-fed (FF) infants (n = 108) received standard pHF-W formula (1.9 g protein/100 kcal) from enrollment (age ≤ 30 days) until age 120 days followed by new pHF-W FoF (1.6 g protein/100 kcal) until 360 days. Weight gain velocity (WGV) (mean daily WG from enrollment to age 180 days) was compared to WHO growth standards and a breastfed (BF) reference group (n = 86) (non-inferiority margin –3 g/day). GI tolerance was assessed using a validated questionnaire (scale range 13−65).ResultsWGV in FF infants (mean ± SD 24.0 ± 4.4 g/day) was non-inferior to BF (23.7 ± 3.9 g/day) and WHO standards (all p ≤ 0.013). Weight-for-age, length-for-age, weight-for-length, and head circumference-for-age z-scores of FF infants were not significantly different from BF at any timepoint. Symptoms of GI intolerance were low (≤23) at all timepoints and similar between groups.ConclusionA new pHF-W FoF with age-adapted protein content fed sequentially after standard pHF-W infant formula is safe, well-tolerated, and promotes a healthy growth pattern consistent with BF infants and WHO standards during the first year of life.Clinical trial registration[https://clinicaltrials.gov/], identifier [NCT03276663].

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“…To obtain hydrolysates, various raw materials of animal (dairy, meat, fish) and vegetable (soy, lentils, beans, chickpeas) origin with a high protein content are used. Thus, the protein component of modern hypoallergenic formulae for infants is represented by extensively or partially hydrolysated milk proteins [9], such as whey, casein proteins or mixtures thereof [10]. Although whey proteins have a balanced composition of essential amino acids [11], β-lactoglobulin, which accounts for 58% of whey proteins (12% of total protein), has the highest allergenic potential [12,13].…”

Section: Introductionmentioning

confidence: 99%

Influence of technological parameters on the degree of enzymatic hydrolysis of high-protein products

Avdieiea¹,

Zhukotskyi²,

Dekusha³

2019

Ukr. food j.

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Introduction. Research have been conducted to determine the influence of technological parameters on the degree of hydrolysis of soy and whey proteins, as well as their mixtures to obtain balanced protein compositions with a high degree of hydrolysis. Materials and methods. Researched here are isolated soy protein, whey protein concentrate and mixtures at different ratio thereof that were hydrolyzed by proteases «Protamex», «Bioprotease N100L» and «Profix 6500». A degree of protein hydrolysis was evaluated by spectrophotometric method, the amino acid composition of hydrolysates was determined using ion exchange chromatography. Results and discussion. To obtain a highly hydrolyzed isolated soy protein rational modes of its proteolysis were determined, namely: mass concentration of protein in an aqueous solution-9%, mass concentration of protease-5%, pH 6.5-7.0, hydrolysis temperature 55-60 °C and duration of the process-60 min. Under these conditions, the degree of hydrolysis of isolated soy protein is 80-82% obtained with «Protamex», 50-51%with «Bioprotease N100L» and 30-33%with «Profix 6500». Hydrolytic effect of the above mentioned proteases on the degree of hydrolysis of whey protein concentrate under the same conditions is slightly less and amounts to 45-46% for «Protamex», 30-33% for «Bioprotease N100L» and 19-20% for «Profix 6500» which can be explained by the smaller specificity of this substrate to the enzymes. To achieve a balanced composition of essential amino acids relative to human milk, it is rational to combine a whey protein concentrate and isolated soy protein in a mass ratio of 1:1 respectively. In doing so, the degree of hydrolysis of this mixture is high and amounts to more than 80% under the action of «Protamex» at a concentration of 5% by weight of protein, a temperature of 55-60 °C and a duration of 60 minutes. Conclusions. For the first time the rational technological parameters for the proteolysis of isolated soy protein, whey protein concentrate and their mixtures were determined to obtain a high degree of hydrolysis.

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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

Cited by 13 publications

References 28 publications

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

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

A new partially hydrolyzed whey-based follow-on formula with age-adapted protein content supports healthy growth during the first year of life

Influence of technological parameters on the degree of enzymatic hydrolysis of high-protein products

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