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

NCT ID: NCT07075822

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-11
• Study Completion Date: 2025-07-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

FiberSMART®

20g of FiberSMART® dissolved in 250ml of water

Group Type: EXPERIMENTAL

20g of FiberSMART®

Intervention Type: OTHER

20g of FiberSMART® dissolved in 250g of water

Dextrose

20g of dextrose dissolved in 250g of water

Group Type: ACTIVE_COMPARATOR

20g of Dextose

Intervention Type: OTHER

20g of dextrose dissolved in 250g of water

Water Control

250g of water

Group Type: PLACEBO_COMPARATOR

Water Control

Intervention Type: OTHER

250g of water

Interventions

20g of FiberSMART®

20g of FiberSMART® dissolved in 250g of water

Intervention Type: OTHER

20g of Dextose

20g of dextrose dissolved in 250g of water

Intervention Type: OTHER

Water Control

250g of water

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anderson Advanced Ingredients

INDUSTRY

Sponsor Role: collaborator

INQUIS Clinical Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas M Wolever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

INQUIS Clinical Research

Locations

INQUIS Clinical Research

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

INQ-2522

Identifier Type: -

Identifier Source: org_study_id