A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared With a Casein-Based Extensively Hydrolyzed Formula

This study compared the growth of healthy infants fed a hypoallergenic 100% whey-based extensively hydrolyzed formula (EHF) with Bifidobacterium lactis (test) with that of infants fed an extensively hydrolyzed casein formula (control). Formula-fed infants (14 ± 3 days) were randomized to test or con...

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Main Authors: David Fields PhD, Laura Czerkies MS, RD, Shumei Sun PhD, Heidi Storm MS, RD, José Saavedra MD, Ricardo Sorensen MD
Format: Article
Language:English
Published: SAGE Publishing 2016-04-01
Series:Global Pediatric Health
Online Access:https://doi.org/10.1177/2333794X16636613
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author David Fields PhD
Laura Czerkies MS, RD
Shumei Sun PhD
Heidi Storm MS, RD
José Saavedra MD
Ricardo Sorensen MD
author_facet David Fields PhD
Laura Czerkies MS, RD
Shumei Sun PhD
Heidi Storm MS, RD
José Saavedra MD
Ricardo Sorensen MD
author_sort David Fields PhD
collection DOAJ
description This study compared the growth of healthy infants fed a hypoallergenic 100% whey-based extensively hydrolyzed formula (EHF) with Bifidobacterium lactis (test) with that of infants fed an extensively hydrolyzed casein formula (control). Formula-fed infants (14 ± 3 days) were randomized to test or control groups until 112 days of age. Anthropometrics were assessed at 14, 28, 56, 84, and 112 days, and daily records were kept for 2 days prior to study visits. Serum albumin and plasma amino acids at 84 days were assessed in a subset. A total of 282 infants were randomized (124 test, 158 control). Significantly more infants dropped out of the control (56%) as compared with the test (41%) group. Mean daily weight gain was significantly higher in the test group compared with the control group (27.95 ± 5.91 vs 25.93 ± 6.12 g/d; P = .027) with the test group reporting significantly fewer stools (2.2 vs 3.6 stools/d; P < .0001). The control group reported significantly more days with >3 loose stools/d and a higher incidence of vomiting as compared with the test group. There were no differences in gas, mood, sleep, or serum albumin. Plasma arginine and valine were significantly lower in the test group, whereas leucine and lysine were higher; all values were within normal limits. Significantly more adverse events attributed to the study formula were reported in the control group. The 100% whey-based hypoallergenic EHF containing Bifidobacterium lactis and medium chain triglycerides supported growth of healthy infants. Future studies on the application of this formula in clinically indicated populations are warranted.
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spelling doaj.art-80f22aed1d8941a8a20412a41ec8dc112022-12-22T00:47:35ZengSAGE PublishingGlobal Pediatric Health2333-794X2016-04-01310.1177/2333794X1663661310.1177_2333794X16636613A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared With a Casein-Based Extensively Hydrolyzed FormulaDavid Fields PhD0Laura Czerkies MS, RD1Shumei Sun PhD2Heidi Storm MS, RD3José Saavedra MD4Ricardo Sorensen MD5University of Oklahoma Health Sciences Center, Oklahoma City, OK, USANestlé Nutrition, Florham Park, NJ, USAVirginia Commonwealth University, Richmond, VA, USANestlé Nutrition, Florham Park, NJ, USANestlé Nutrition, Vevey, SwitzerlandLouisiana State University, New Orleans, LA, USAThis study compared the growth of healthy infants fed a hypoallergenic 100% whey-based extensively hydrolyzed formula (EHF) with Bifidobacterium lactis (test) with that of infants fed an extensively hydrolyzed casein formula (control). Formula-fed infants (14 ± 3 days) were randomized to test or control groups until 112 days of age. Anthropometrics were assessed at 14, 28, 56, 84, and 112 days, and daily records were kept for 2 days prior to study visits. Serum albumin and plasma amino acids at 84 days were assessed in a subset. A total of 282 infants were randomized (124 test, 158 control). Significantly more infants dropped out of the control (56%) as compared with the test (41%) group. Mean daily weight gain was significantly higher in the test group compared with the control group (27.95 ± 5.91 vs 25.93 ± 6.12 g/d; P = .027) with the test group reporting significantly fewer stools (2.2 vs 3.6 stools/d; P < .0001). The control group reported significantly more days with >3 loose stools/d and a higher incidence of vomiting as compared with the test group. There were no differences in gas, mood, sleep, or serum albumin. Plasma arginine and valine were significantly lower in the test group, whereas leucine and lysine were higher; all values were within normal limits. Significantly more adverse events attributed to the study formula were reported in the control group. The 100% whey-based hypoallergenic EHF containing Bifidobacterium lactis and medium chain triglycerides supported growth of healthy infants. Future studies on the application of this formula in clinically indicated populations are warranted.https://doi.org/10.1177/2333794X16636613
spellingShingle David Fields PhD
Laura Czerkies MS, RD
Shumei Sun PhD
Heidi Storm MS, RD
José Saavedra MD
Ricardo Sorensen MD
A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared With a Casein-Based Extensively Hydrolyzed Formula
Global Pediatric Health
title A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared With a Casein-Based Extensively Hydrolyzed Formula
title_full A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared With a Casein-Based Extensively Hydrolyzed Formula
title_fullStr A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared With a Casein-Based Extensively Hydrolyzed Formula
title_full_unstemmed A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared With a Casein-Based Extensively Hydrolyzed Formula
title_short A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared With a Casein-Based Extensively Hydrolyzed Formula
title_sort randomized controlled trial assessing growth of infants fed a 100 whey extensively hydrolyzed formula compared with a casein based extensively hydrolyzed formula
url https://doi.org/10.1177/2333794X16636613
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