Demonstrate That the Postprandial Glucose Response of FiberSMART is Consistent With the Response Expected From a Dietary FiberNCT07075822
Effect of Tapioca-based FiberSMART® Compared to a Glucose Challenge or Water Control on Postprandial Glycemia in Healthy Subjects: An Acute Randomized Controlled Trial
A study testing 20g of FiberSMART® and 20g of Dextose in people with Demonstrate That the Postprandial Glucose Response of FiberSMART is Consistent With the Response Expected From a Dietary Fiber, run by INQUIS Clinical Research at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Demonstrate That the Postprandial Glucose Response of FiberSMART is Consistent With the Response Expected From a Dietary Fiber
- What is being tested?
- 20g of FiberSMART® and 20g of Dextose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jun 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
- Being tested
- 20g of FiberSMART®, 20g of Dextose, Water Control
- Keywords
- dietary fiber, postprandial glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20g of FiberSMART®Other
20g of FiberSMART® dissolved in 250g of water
20g of DextoseOther
20g of dextrose dissolved in 250g of water
Water ControlOther
250g of water
| Study group | Role | What they receive |
|---|---|---|
| FiberSMART® | Experimental | 20g of FiberSMART® dissolved in 250ml of water Receives: Other: 20g of FiberSMART® |
| Dextrose | Active comparator | 20g of dextrose dissolved in 250g of water Receives: Other: 20g of Dextose |
| Water Control | Placebo comparator | 250g of water Receives: Other: Water Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours post-prandial
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: 2 hour postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start11 Jun 2025
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demonstrate That the Postprandial Glucose Response of FiberSMART is Consistent With the Response Expected From a Dietary FiberStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- INQUIS Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anderson Advanced Ingredients
- Responsible party
- Sponsor
- Investigators
- Thomas M Wolever, MD, PhD, Principal investigator, INQUIS Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075822
- Sponsor's protocol ID
- INQ-2522
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tapioca-based FiberSMART® Compared to a Glucose Challenge or Water Control on Postprandial Glycemia in Healthy Subjects: An Acute Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07075822
- Acronym / sponsor ID
- INQ-2522
- Keywords
- dietary fiber, postprandial glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- INQUIS Clinical ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Anderson Advanced Ingredients
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FiberSMART® | Experimental | Other: 20g of FiberSMART®20g of FiberSMART® dissolved in 250ml of water |
| Dextrose | Active comparator | Other: 20g of Dextose20g of dextrose dissolved in 250g of water |
| Water Control | Placebo comparator | Other: Water Control250g of water |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20g of FiberSMART®20g of FiberSMART® dissolved in 250g of water | Other | FiberSMART® |
| 20g of Dextose20g of dextrose dissolved in 250g of water | Other | Dextrose |
| Water Control250g of water | Other | Water Control |
Primary outcome
Blood Glucose iAUC
Time frame: 2 hours post-prandial
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.
3 secondary outcomes
Posprandial glucose levels at each time point
Time frame: 2 hour postprandial
Glucose Peak Height
Time frame: 2 hours post-prandial
Glucose Tmax
Time frame: 2 hour postprandial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M Wolever, MD, PhD principal investigator
INQUIS Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20g of FiberSMART® and 20g of Dextose in people with Demonstrate That the Postprandial Glucose Response of FiberSMART is Consistent With the Response Expected From a Dietary Fiber, run by INQUIS Clinical Research at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose iAUC (time frame: 2 hours post-prandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.