Nourishing the Infant Gut Microbiome to Support Immune Health: Protocol of SUN (Seeding Through Feeding) Randomized Controlled Trial.
Autor: | Wall CR; Department of Nutrition and Dietetics, University of Auckland, Auckland, New Zealand.; High-Value Nutrition, National Science Challenge, Auckland, New Zealand., Roy NC; High-Value Nutrition, National Science Challenge, Auckland, New Zealand.; Department of Nutrition, University of Otago, Dunedin, New Zealand., Mullaney JA; High-Value Nutrition, National Science Challenge, Auckland, New Zealand.; AgResearch, Palmerston North, New Zealand.; Riddet Institute, Massey University, Palmerston North, New Zealand., McNabb WC; High-Value Nutrition, National Science Challenge, Auckland, New Zealand.; Riddet Institute, Massey University, Palmerston North, New Zealand., Gasser O; High-Value Nutrition, National Science Challenge, Auckland, New Zealand.; Malaghan Institute of Medical Research, Wellington, New Zealand., Fraser K; High-Value Nutrition, National Science Challenge, Auckland, New Zealand.; AgResearch, Palmerston North, New Zealand., Altermann E; BlueBarn Life Sciences Ltd., Palmerston North, New Zealand.; School of Veterinary Science, Massey University, Palmerston North, New Zealand., Young W; Fonterra, Palmerston North, New Zealand., Cooney J; High-Value Nutrition, National Science Challenge, Auckland, New Zealand.; The New Zealand Institute for Plant and Food Research Ltd, Hamilton, New Zealand., Lawrence R; Department of Nutrition and Dietetics, University of Auckland, Auckland, New Zealand.; High-Value Nutrition, National Science Challenge, Auckland, New Zealand., Jiang Y; Department of Statistics, University of Auckland, Auckland, New Zealand., Galland BC; Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand., Fu X; Department of Nutrition and Dietetics, University of Auckland, Auckland, New Zealand.; High-Value Nutrition, National Science Challenge, Auckland, New Zealand., Tonkie JN; High-Value Nutrition, National Science Challenge, Auckland, New Zealand.; School of Food and Advanced Technology, Massey University, Palmerston North, New Zealand., Mahawar N; Department of Nutrition and Dietetics, University of Auckland, Auckland, New Zealand.; High-Value Nutrition, National Science Challenge, Auckland, New Zealand., Lovell AL; Department of Nutrition and Dietetics, University of Auckland, Auckland, New Zealand.; High-Value Nutrition, National Science Challenge, Auckland, New Zealand. |
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Jazyk: | angličtina |
Zdroj: | JMIR research protocols [JMIR Res Protoc] 2024 Sep 02; Vol. 13, pp. e56772. Date of Electronic Publication: 2024 Sep 02. |
DOI: | 10.2196/56772 |
Abstrakt: | Background: The introduction of complementary foods during the first year of life influences the diversity of the gut microbiome. How this diversity affects immune development and health is unclear. Objective: This study evaluates the effect of consuming kūmara or kūmara with added banana powder (resistant starch) compared to a reference control at 4 months post randomization on the prevalence of respiratory tract infections and the development of the gut microbiome. Methods: This study is a double-blind, randomized controlled trial of mothers and their 6-month-old infants (up to n=300) who have not yet started solids. Infants are randomized into one of 3 groups: control arm (C), standard kūmara intervention (K), and a kūmara intervention with added banana powder product (K+) to be consumed daily for 4 months until the infant is approximately 10 months old. Infants are matched for sex using stratified randomization. Data are collected at baseline (prior to commencing solid food) and at 2 and 4 months after commencing solid food (at around 8 and 10 months of age). Data and samples collected at each timepoint include weight and length, intervention adherence (months 2 and 4), illness and medication history, dietary intake (months 2 and 4), sleep (diary and actigraphy), maternal dietary intake, breast milk, feces (baseline and 4 months), and blood samples (baseline and 4 months). Results: The trial was approved by the Health and Disability Ethics Committee of the Ministry of Health, New Zealand (reference 20/NTA/9). Recruitment and data collection did not commence until January 2022 due to the COVID-19 pandemic. Data collection and analyses are expected to conclude in January 2024 and early 2025, respectively. Results are to be published in 2024 and 2025. Conclusions: The results of this study will help us understand how the introduction of a specific prebiotic complementary food affects the microbiota and relative abundances of the microbial species, the modulation of immune development, and infant health. It will contribute to the expanding body of research that aims to deepen our understanding of the connections between nutrition, gut microbiota, and early-life postnatal health. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000026921; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378654. International Registered Report Identifier (irrid): DERR1-10.2196/56772. (©Clare R Wall, Nicole C Roy, Jane A Mullaney, Warren Charles McNabb, Olivier Gasser, Karl Fraser, Eric Altermann, Wayne Young, Janine Cooney, Robyn Lawrence, Yannan Jiang, Barbara C Galland, Xiaoxi Fu, Jacqueline N Tonkie, Nisha Mahawar, Amy Luisa Lovell. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 02.09.2024.) |
Databáze: | MEDLINE |
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