Evaluating the effect of prebiotics on the gut microbiome profile and β cell function in youth with newly diagnosed type 1 diabetes: protocol of a pilot randomized controlled trial

Pilot and Feasibility Studies

Study Protocol

Carmella Evans-Molina¹  Linda A. DiMeglio²  Heba M. Ismail²  Maria Spall² 

[1] Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA;Department of Pediatrics, Indiana University School of Medicine, 635 Barnhill Drive

[2]  MS 2053, 46202, Indianapolis, IN, USA;

关键词: Randomized trial;    Children;    Type 1 diabetes;    Microbiota;    Prebiotics;   

DOI  :  10.1186/s40814-023-01373-4

 received in 2022-09-20, accepted in 2023-08-03,  发布年份 2023

来源: Springer

【 摘 要 】

IntroductionData show that disturbances in the gut microbiota play a role in glucose homeostasis, type 1 diabetes (T1D) risk and progression. The prebiotic high amylose maize starch (HAMS) alters the gut microbiome profile and metabolites favorably with an increase in bacteria producing short chain fatty acids (SCFAs) that have significant anti-inflammatory effects. HAMS also improves glycemia, insulin sensitivity, and secretion in healthy non-diabetic adults. Additionally, a recent study testing an acetylated and butyrylated form of HAMS (HAMS-AB) that further increases SCFA production prevented T1D in a rodent model without adverse safety effects. The overall objective of this human study will be to assess how daily HAMS-AB consumption impacts the gut microbiome profile, SCFA production, β cell heath, function, and glycemia as well as immune responses in newly diagnosed T1D youth.Methods and analysisWe hypothesize that HAMS-AB intake will improve the gut microbiome profile, increase SCFA production, improve β cell health, function and glycemia as well as modulate the immune system. We describe here a pilot, randomized crossover trial of HAMS-AB in 12 newly diagnosed T1D youth, ages 11–17 years old, with residual β cell function. In Aim 1, we will determine the effect of HAMS-AB on the gut microbiome profile and SCFA production; in Aim 2, we will determine the effect of HAMS-AB on β cell health, function and glycemia; and in Aim 3, we will determine the peripheral blood effect of HAMS-AB on frequency, phenotype and function of specific T cell markers. Results will be used to determine the effect-size estimate of using HAMS-AB. We anticipate beneficial effects from a simple, inexpensive, and safe dietary approach.Ethics and disseminationThe Institutional Review Board at Indiana University approved the study protocol. The findings of this trial will be submitted to a peer-reviewed pediatric journal. Abstracts will be submitted to relevant national and international conferences.Trial registrationNCT04114357; Pre-results.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023