Data suggest that intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch (HAMS-AB) that increases beneficial short chain fatty acid (SCFA) production has been safe and effective in disease prevention in mouse type 1 diabetes (T1D) models. The objective of this application is to assess the effect of administering a prebiotic, such as HAMS- AB, on the gut microbiome profile, glycemia and β-cell function in humans with T1D.
This is a pilot, single center clinical trial to evaluate the effect of using the prebiotic, HAMS-AB, on the gut microbiome profile, glycemia and β-cell function in children and adolescents ages 12-16 years with recently diagnosed type 1 diabetes. Approximately 12 participants will be randomized to first to take the supplement and follow the diabetic diet or follow a diabetic diet alone for 4 weeks and then cross-over after a 4 week washout period. The primary objective is to determine the effect of using the prebiotic on the gut microbiome profile in youth with T1D. The secondary objectives are to determine the effect of using the prebiotic on SCFA production, glycemia and β-cell health and function. Exploratory outcomes include changes in MAIT cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner for 4 weeks
Indiana University School of Medicine
Indianapolis, Indiana, United States
Change in the Gut Microbiome Profile
We planned to assess the effect of administering acetylated and butyrylated high amylose maize starch (HAMS-AB) on the gut microbiome profile in people with recently-diagnosed type 1 diabetes (T1D) by sequencing the gut microbiome profile. This measure was assesed using the absolute abundance of certain bacterial species of interest. The changes will be compared before and after each 4 week time period.
Time frame: before and after completion of each 4 week sequence
Changes in the Short Chain Fatty Acid Levels in the Gut.
Measurement of Short Chain Fatty Acid Levels in the Stools.
Time frame: before and after completion of each 4 week sequence
Changes in Average Glucose
We will compare average glucose changes pre/post intervention with HAMS-AB. We will compare their glycemic changes using continuous glucose monitoring data.
Time frame: before and after completion of each 4 week sequence
C-peptide Levels (Changes in Beta Cell Health).
We will compare β-cell measures pre/post intervention with HAMS-AB and between the intervention and control groups. We will assess β-cell function using mixed meal tolerance-derived C-peptide measurements ( a measure of β-cell function).
Time frame: before and after completion of each 4 week sequence
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