TY - JOUR
T1 - Effects of a Novel High-Quality Protein Infant Formula on Energetic Efficiency and Tolerance
T2 - A Randomized Trial
AU - Kuehn, Devon
AU - Zeisel, Steven H.
AU - Orenstein, Diana F.
AU - German, J. Bruce
AU - Field, Catherine J.
AU - Teerdhala, Shiva
AU - Knezevic, Andrea
AU - Patil, Sujata
AU - Donovan, Sharon M.
AU - Lönnerdal, Bo
N1 - Funding Information:
S.Z. receives an honorarium as part of the ByHeart Scientific Advisory Board. Bruce German receives an honorarium as part of the ByHeart Scientific Advisory Board. C.F. receives an honorarium as part of the ByHeart Scientific Advisory Board. S.D. receives an honorarium as part of the ByHeart Scientific Advisory Board and has received research grants from ByHeart. In addition, S.D. serves on Scientific Advisory Boards for Austnutria, Danone North America, Danone Institute International, and the National Dairy Council. She currently receives grant funding from General Mills, International Foods and Fragrances, Kyowa Hakka Bio, the National Dairy Council, National Institutes of Health (NIH), and the U.S. Department of Agriculture. B.L. receives an honorarium as part of the ByHeart Scientific Advisory Board and has received research grants from ByHeart. The remaining authors report no conflicts of interest.
Funding Information:
Sources of Funding: This trial was funded by ByHeart, Inc. No funding was received from National Institutes of Health (NIH), Wellcome Trust, Howard Hughes Medical Institute, or other sources.
Publisher Copyright:
© 2022 The Author(s). Published by Wolters Kluwer on behalf of European Society for Pediatric Gastroenterology.
PY - 2022/10/1
Y1 - 2022/10/1
N2 - 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.
AB - 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.
KW - alpha-lactalbumin
KW - growth
KW - nutrition
KW - tryptophan
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U2 - 10.1097/MPG.0000000000003490
DO - 10.1097/MPG.0000000000003490
M3 - Article
C2 - 35666855
AN - SCOPUS:85138457820
SN - 0277-2116
VL - 75
SP - 521
EP - 528
JO - Journal of Pediatric Gastroenterology and Nutrition
JF - Journal of Pediatric Gastroenterology and Nutrition
IS - 4
ER -