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

NCT07075822 | Completed

• 1 other identifier: INQ-2522
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

dietary fiber, postprandial glucose

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours post-prandial

Secondary Outcomes (3)

• Posprandial glucose levels at each time point

  2 hour postprandial

• Glucose Peak Height

  2 hours post-prandial

• Glucose Tmax

  2 hour postprandial

Study Arms (3)

FiberSMART®

EXPERIMENTAL

20g of FiberSMART® dissolved in 250ml of water

Other: 20g of FiberSMART®

Dextrose

ACTIVE COMPARATOR

20g of dextrose dissolved in 250g of water

Other: 20g of Dextose

Water Control

PLACEBO COMPARATOR

250g of water

Other: Water Control

Interventions

20g of FiberSMART® OTHER

20g of FiberSMART® dissolved in 250g of water

FiberSMART®

20g of Dextose OTHER

20g of dextrose dissolved in 250g of water

Dextrose

Water Control OTHER

250g of water

Water Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• INQUIS Clinical Research: lead
• Anderson Advanced Ingredients: collaborator

Study Sites (1)

INQUIS Clinical Research

Toronto, Ontario, M5C2N8, Canada

Location

Study Officials

• Thomas M Wolever, MD, PhD

  INQUIS Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: June 11, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)