Open AccessEffects of a Novel High‐Quality Protein Infant Formula on Energetic Efficiency and Tolerance
Author(s) -
Kuehn Devon,
Zeisel Steven H.,
Orenstein Diana F.,
German J. Bruce,
Field Catherine J.,
Teerdhala Shiva,
Knezevic Andrea,
Patil Sujata,
Donovan Sharon M.,
Lönnerdal Bo
Publication year - 2022
Publication title -
journal of pediatric gastroenterology and nutrition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 131
eISSN - 1536-4801
pISSN - 0277-2116
DOI - 10.1097/mpg.0000000000003490
Subject(s) - medicine , infant formula , confidence interval , randomized controlled trial , anthropometry , placebo , pediatrics , adverse effect , hydrolyzed protein , protein quality , gastroenterology , zoology , biochemistry , hydrolysis , chemistry , alternative medicine , pathology , biology
Objectives: Protein overfeeding in infants can have negative effects, such as diabetes and childhood obesity; key to reducing protein intake from formula is improving protein quality. The impact of a new infant formula [study formula (SF)] containing alpha‐lactalbumin, lactoferrin, partially hydrolyzed whey, and whole milk on growth and tolerance compared to a commercial formula (CF) and a human milk reference arm was evaluated. Methods: This randomized, double‐blind trial included healthy, singleton, term infants, enrollment age ≤14 days. Primary outcome was mean daily weight gain. Secondary outcomes were anthropometrics, formula intake, serum amino acids, adverse events, gastrointestinal characteristics, and general disposition. Results: Non‐inferiority was demonstrated. There were no differences between the formula groups for z scores over time. Formula intake [−0.33 oz/kg/day, 95% confidence interval (CI): −0.66 to −0.01, P = 0.05] and mean protein intake (−0.13 g/kg/day, 95% CI: −0.26 to 0.00, P = 0.05) were lower in the SF infants, with higher serum essential amino acid concentrations (including tryptophan) compared to the CF infants. Energetic efficiency was 14.0% (95% CI: 8.3%, 19.7%), 13.0% (95% CI: 6.0%, 20.0%), and 18.1% (95% CI: 9.4%, 26.8%) higher for weight, length, and head circumference, respectively, in SF infants compared to the CF infants. SF infants had significantly fewer spit‐ups and softer stool consistency than CF infants. Conclusions: The SF resulted in improved parent‐reported gastrointestinal tolerance and more efficient growth with less daily formula and protein intake supporting that this novel formula may potentially reduce the metabolic burden of protein overfeeding associated with infant formula.