Effect of Tapioca-based FiberSMART® Compared to a Glucose Challenge or Water Control on Postprandial Glycemia in Healthy Subjects: An Acute Randomized Controlled Trial

INQUIS Clinical Research15 enrolled

Overview

The goal of this clinical trial is to learn whether a novel tapioca-based soluble fiber, FiberSMART®, affects blood glucose levels after consumption in healthy adult volunteers. The main questions it aims to answer are: Does FiberSMART® raise postprandial (after-meal) blood glucose levels? Is the blood glucose response to FiberSMART® different from that of dextrose or water? Researchers will compare participants' blood glucose responses after consuming 20g of FiberSMART® to their responses after consuming 20g of dextrose or a water control to see if FiberSMART® results in a lower postprandial glucose rise than the dextrose challenge and is no different from the water challenge. Demonstrating the FiberSMART acts like a dietary fiber. Participants will: Visit the clinic on three separate mornings after an overnight fast Consume either 20g of FiberSMART® or 20g of dextrose or a water control Undergo 8 finger-prick blood tests over 2 hours to measure blood glucose levels

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Demonstrate That the Postprandial Glucose Response of FiberSMART is Consistent With the Response Expected From a Dietary Fiber

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects are healthy adult males and non-pregnant females. Subjects must be eligible to receive income in Canada. Family members of staff and/or staff that have no responsibilities/tasks on this particular trial may be subjects Exclusion Criteria: * age less than 18 years; * any known food allergies or intolerances to the investigational product; * medications known to affect glucose tolerance -but stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable; * known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions; * any major medical or surgical events requiring hospitalization within the preceding 3 months; * the presence of disease or drug(s) which influence digestion and absorption of nutrients; * the short-term use of systemic steroids or atypical antipsychotics (\<4 weeks) (all of which have major effects on glucose and metabolism and body fat distribution) * any other medications or conditions which might, in the opinion of the Medical Director of INQUIS Clinical Research Ltd. (INQUIS), either 1) make participation dangerous to the subject or to others, or 2) affect the results; * any subject who cannot or will not comply with the experimental procedures or do not follow INQUIS safety guidelines.

Outcomes

Primary Outcomes

Blood Glucose iAUC

Determine the 2 hour iAUC of FiberSMART® and compare it to the iAUC of dextrose (positive control) and water (negative control). Incremental area under the blood glucose curve (iAUC) will be calculated using the trapezoid rule, ignoring the area beneath the baseline.

Time frame: 2 hours post-prandial

Secondary Outcomes

Posprandial glucose levels at each time point

Compare the blood glucose levels at each time point after consuming 20g FiberSMART® or 20g of dextrose (positive control) or water (negative control).

Time frame: 2 hour postprandial

Glucose Peak Height

Determine the blood glucose peak height (mmol/L) after consuming 20g FiberSMART® and compare it to the blood glucose peak height after consuming 20g of dextrose (positive control) or water (negative control).

Time frame: 2 hours post-prandial

Glucose Tmax

Determine the time to maximum postprandial glucose level glucose peak height (mmol/L) after consuming 20g FiberSMART® and compare it to the blood glucose peak height after consuming 20g of dextrose (positive control) or water (negative control).