Effect of Tapioca-based FiberSMART® Compared to a Glucose... | NCT07075822

Studies
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

Sponsor

INQUIS Clinical Research

Status

Completed

Last Update Posted

Aug 24, 2025Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

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

Interventions

20g of FiberSMART®
20g of Dextose
Water Control

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2025Actual

Primary Completion Date

Jul 15, 2025Actual

Completion Date

Jul 15, 2025Actual

First Submitted Date

Jul 10, 2025

First Submission Date that Met QC Criteria

Jul 10, 2025

First Posted Date

Jul 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2025

Last Update Posted Date

Aug 24, 2025Actual

Name	Class
Anderson Advanced Ingredients	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
20g of FiberSMART®	Other	20g of FiberSMART® dissolved in 250g of water	FiberSMART®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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).	2 hour postprandial
Glucose Peak Height

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Thomas M Wolever, MD, PhD	INQUIS Clinical Research	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
INQUIS Clinical Research		Toronto	Ontario	M5C2N8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided