Cargando…
Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial
BACKGROUND: Optimal protein level in hypoallergenic infant formulas is an area of ongoing investigation. The aim was to evaluate growth of healthy term infants who received extensively hydrolyzed (EH) or amino acid (AA)-based formulas with reduced protein. METHODS: In this prospective, multi-center,...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8293492/ https://www.ncbi.nlm.nih.gov/pubmed/34289820 http://dx.doi.org/10.1186/s12887-021-02617-z |
_version_ | 1783725050451460096 |
---|---|
author | Adams, Craig B. Johnston, William H. Deulofeut, Harold Leader, Joseph Rhodes, Robbie Yeiser, Michael Harris, Cheryl L. Wampler, Jennifer L. Hill, Rebecca J. Cooper, Timothy |
author_facet | Adams, Craig B. Johnston, William H. Deulofeut, Harold Leader, Joseph Rhodes, Robbie Yeiser, Michael Harris, Cheryl L. Wampler, Jennifer L. Hill, Rebecca J. Cooper, Timothy |
author_sort | Adams, Craig B. |
collection | PubMed |
description | BACKGROUND: Optimal protein level in hypoallergenic infant formulas is an area of ongoing investigation. The aim was to evaluate growth of healthy term infants who received extensively hydrolyzed (EH) or amino acid (AA)-based formulas with reduced protein. METHODS: In this prospective, multi-center, double-blind, controlled, parallel group study, infants were randomized to receive a marketed EH casein infant formula at 2.8 g protein/100 kcal (Control) or one of two investigational formulas: EH casein formula at 2.4 g protein/100 kcal (EHF) or AA-based formula at 2.4 g total protein equivalents/100 kcal (AAF). Control and EHF each had 2 × 10(7) CFU Lactobacillus rhamnosus GG/100 kcal. Anthropometrics were measured and recall of formula intake, tolerance, and stool characteristics was collected at 14, 30, 60, 90, 120 days of age. Primary outcome was weight growth rate (g/day) between 14 and 120 days of age (analyzed by ANOVA). Medically confirmed adverse events were recorded throughout the study. RESULTS: No group differences in weight or length growth rate from 14 to 120 days were detected. With the exception of significant differences at several study time points for males, no group differences were detected in mean head circumference growth rates. However, mean achieved weight, length, and head circumference demonstrated normal growth throughout the study period. No group differences in achieved weight or length (males and females) and head circumference (females) were detected and means were within the WHO growth 25th and 75th percentiles from 14 to 120 days of age. With the exception of Day 90, there were no statistically significant group differences in achieved head circumference for males; means remained between the WHO 50th and 75th percentiles for growth at Days 14, 30, and 60 and continued along the 75th percentile through Day 120. No differences in study discontinuation due to formula were detected. The number of participants for whom at least one adverse event was reported was similar among groups. CONCLUSIONS: This study demonstrated hypoallergenic infant formulas at 2.4 g protein/100 kcal were safe, well-tolerated, and associated with appropriate growth in healthy term infants from 14 to 120 days of age. TRIAL REGISTRATION: ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT01354366. Registered 13 May 2011. |
format | Online Article Text |
id | pubmed-8293492 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-82934922021-07-21 Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial Adams, Craig B. Johnston, William H. Deulofeut, Harold Leader, Joseph Rhodes, Robbie Yeiser, Michael Harris, Cheryl L. Wampler, Jennifer L. Hill, Rebecca J. Cooper, Timothy BMC Pediatr Research Article BACKGROUND: Optimal protein level in hypoallergenic infant formulas is an area of ongoing investigation. The aim was to evaluate growth of healthy term infants who received extensively hydrolyzed (EH) or amino acid (AA)-based formulas with reduced protein. METHODS: In this prospective, multi-center, double-blind, controlled, parallel group study, infants were randomized to receive a marketed EH casein infant formula at 2.8 g protein/100 kcal (Control) or one of two investigational formulas: EH casein formula at 2.4 g protein/100 kcal (EHF) or AA-based formula at 2.4 g total protein equivalents/100 kcal (AAF). Control and EHF each had 2 × 10(7) CFU Lactobacillus rhamnosus GG/100 kcal. Anthropometrics were measured and recall of formula intake, tolerance, and stool characteristics was collected at 14, 30, 60, 90, 120 days of age. Primary outcome was weight growth rate (g/day) between 14 and 120 days of age (analyzed by ANOVA). Medically confirmed adverse events were recorded throughout the study. RESULTS: No group differences in weight or length growth rate from 14 to 120 days were detected. With the exception of significant differences at several study time points for males, no group differences were detected in mean head circumference growth rates. However, mean achieved weight, length, and head circumference demonstrated normal growth throughout the study period. No group differences in achieved weight or length (males and females) and head circumference (females) were detected and means were within the WHO growth 25th and 75th percentiles from 14 to 120 days of age. With the exception of Day 90, there were no statistically significant group differences in achieved head circumference for males; means remained between the WHO 50th and 75th percentiles for growth at Days 14, 30, and 60 and continued along the 75th percentile through Day 120. No differences in study discontinuation due to formula were detected. The number of participants for whom at least one adverse event was reported was similar among groups. CONCLUSIONS: This study demonstrated hypoallergenic infant formulas at 2.4 g protein/100 kcal were safe, well-tolerated, and associated with appropriate growth in healthy term infants from 14 to 120 days of age. TRIAL REGISTRATION: ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT01354366. Registered 13 May 2011. BioMed Central 2021-07-21 /pmc/articles/PMC8293492/ /pubmed/34289820 http://dx.doi.org/10.1186/s12887-021-02617-z Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Adams, Craig B. Johnston, William H. Deulofeut, Harold Leader, Joseph Rhodes, Robbie Yeiser, Michael Harris, Cheryl L. Wampler, Jennifer L. Hill, Rebecca J. Cooper, Timothy Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial |
title | Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial |
title_full | Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial |
title_fullStr | Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial |
title_full_unstemmed | Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial |
title_short | Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial |
title_sort | growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8293492/ https://www.ncbi.nlm.nih.gov/pubmed/34289820 http://dx.doi.org/10.1186/s12887-021-02617-z |
work_keys_str_mv | AT adamscraigb growthandtoleranceofhealthyterminfantsfedlowerproteinextensivelyhydrolyzedoraminoacidbasedformuladoubleblindrandomizedcontrolledtrial AT johnstonwilliamh growthandtoleranceofhealthyterminfantsfedlowerproteinextensivelyhydrolyzedoraminoacidbasedformuladoubleblindrandomizedcontrolledtrial AT deulofeutharold growthandtoleranceofhealthyterminfantsfedlowerproteinextensivelyhydrolyzedoraminoacidbasedformuladoubleblindrandomizedcontrolledtrial AT leaderjoseph growthandtoleranceofhealthyterminfantsfedlowerproteinextensivelyhydrolyzedoraminoacidbasedformuladoubleblindrandomizedcontrolledtrial AT rhodesrobbie growthandtoleranceofhealthyterminfantsfedlowerproteinextensivelyhydrolyzedoraminoacidbasedformuladoubleblindrandomizedcontrolledtrial AT yeisermichael growthandtoleranceofhealthyterminfantsfedlowerproteinextensivelyhydrolyzedoraminoacidbasedformuladoubleblindrandomizedcontrolledtrial AT harrischeryll growthandtoleranceofhealthyterminfantsfedlowerproteinextensivelyhydrolyzedoraminoacidbasedformuladoubleblindrandomizedcontrolledtrial AT wamplerjenniferl growthandtoleranceofhealthyterminfantsfedlowerproteinextensivelyhydrolyzedoraminoacidbasedformuladoubleblindrandomizedcontrolledtrial AT hillrebeccaj growthandtoleranceofhealthyterminfantsfedlowerproteinextensivelyhydrolyzedoraminoacidbasedformuladoubleblindrandomizedcontrolledtrial AT coopertimothy growthandtoleranceofhealthyterminfantsfedlowerproteinextensivelyhydrolyzedoraminoacidbasedformuladoubleblindrandomizedcontrolledtrial |