The primary objective of this clinical-trial is to determine, in subjects with impaired fasting glucose (IFG) and/or insulin resistance (IR), if tagatose meets the definition of a prebiotic, namely that consuming tagatose for 4 weeks selectively stimulates the selective growth of bacteria in the colon and is associated with a health benefit (oral glucose tolerance) when compared to consuming the control treatment (10g sucrose) for 4 weeks.
Available evidence suggests that tagatose may act as a prebiotic compound. It has been hypothesized that undigested tagatose reaches the colon and is fermented by colonic bacteria, resulting in the production of short-chain fatty acids (SCFA) which stimulate GLP-1 secretion from colonic L-cells, which, in turn, improves glycemic control by increasing insulin sensitivity and insulin secretion. However, the fermentation of tagatose and subsequent effects have only been demonstrated in preclinical models, with limited clinical trials examining the effect of tagatose on glycemic control. Given the dearth of clinical evidence in humans supporting the ability of tagatose to be fermented in the colon and to improve glycemic control, the present study aims to explore if tagatose is selectively utilized by human gut microorganisms conferring a beneficial effect on glycemic control. Thus, the investigators aim to recruit 55 healthy adults with impaired fasting glucose and/or hyperinsulinemia into a double-blind, randomized, controlled, clinical trial with a cross-over design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
59
Sachet containing 10g tagatose to be dissolved in 250ml water and taken once daily on Days 1-28 of a 4-week dosing period. (1 of 2 dosing periods separated by a 4-week washout)
Sachet containing 10g sucrose to be dissolved in 250ml water and taken once daily on Days 1-28 of a 4-week dosing period. (1 of 2 dosing periods separated by a 4-week washout)
INQUIS Clinical Research
Toronto, Ontario, Canada
Change in incremental area under the plasma glucose curve (ignoring area below the baseline, iAUC) over each 4-week intervention period
Finger stick blood samples obtained fasted prior to consuming 50 grams of glucose. Six additional finger stick blood samples obtained over the next 2 hours beginning 15 minutes after consumption.
Time frame: Before (-5 minutes and 0 minutes) and 15, 30, 45, 60, 90 and 120 minutes after overnight fasted subjects start to consume 50 grams of glucose on Day 1 and Day 29 of each of two 4-week intervention periods
Fecal microbiota composition
Stool sample measured via 16S rRNA sequencing
Time frame: Pre-dose baseline and Week 4 for each of two 4-week dosing periods
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