AUTHOR=Billeaud Claude , Adamon Latif , Piloquet Hugues , Hays Nicholas P. , Dupuis Lénaïck , Metreau Isabelle , Léké André 

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

JOURNAL=Frontiers in Pediatrics

VOLUME=10

YEAR=2022

URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.937882

DOI=10.3389/fped.2022.937882

ISSN=2296-2360

ABSTRACT=<sec><title>Background</title><p>Standard 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.</p></sec><sec><title>Methods</title><p>Formula-fed (FF) infants (<italic>n</italic> = 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 (<italic>n</italic> = 86) (non-inferiority margin –3 g/day). GI tolerance was assessed using a validated questionnaire (scale range 13−65).</p></sec><sec><title>Results</title><p>WGV 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 <italic>p</italic> ≤ 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.</p></sec><sec><title>Conclusion</title><p>A 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.</p></sec><sec><title>Clinical trial registration</title><p>[<ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov/</ext-link>], identifier [NCT03276663].</p></sec>