Glycemic ResponseNCT06048978
Blood Glucose Response of Processed Starch
A study testing Commercial native starch without processing and Modified starch with extrusion processing in people with Glycemic Response, run by INQUIS Clinical Research at 1 site in Canada.
Trial summary
The goal of this clinical trial is to determine the postprandial glycemic response of the two starches in humans. Participants will be asked to consume 2 test foods on 2 separate occasions and provide blood glucose samples over 120 minutes postprandial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response
- What is being tested?
- Commercial native starch without processing and Modified starch with extrusion processing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2023to 30 Nov 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult males or non-pregnant females.
- eligible to receive income in Canada.
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
Show all 9Show fewer
- 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
Official title: The Effect of Starch Processing on Postprandial Blood Glucose in Humans
The goal of this clinical trial is to determine the postprandial glycemic response of the two starches in humans. Participants will be asked to consume 2 test foods on 2 separate occasions and provide blood glucose samples over 120 minutes postprandial.
Read the detailed description
Enrolled participants who are generally healthy and free of major chronic conditions will be randomized to receive either Commercial Native Starch or Extrusion Processed Starch first and then will be crossed over to receive the opposite Intervention. The study will consist of two clinical test visits of 120 minutes separated by a washout period of at least 24 hours.
- Conditions
- Glycemic Response
- Being tested
- Commercial native starch without processing, Modified starch with extrusion processing
- Keywords
- Postprandial Glycemia, Blood Glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial native starch without processingOther
A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.
Modified starch with extrusion processingOther
A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.
| Study group | Role | What they receive |
|---|---|---|
| Native Starch, then Processed Starch | Experimental | Participants will first receive the Commercial Native Starch in a fasting state in one clinical visit. After a washout of >24 hours, the participants will then receive the Extrusion Processed Starch in a fasting state in one clinical visit. Receives: Other: Commercial native starch without processing; Other: Modified starch with extrusion processing |
| Processed Starch, then Native Starch | Experimental | Participants will first receive the Extrusion Processed Starch in a fasting state in one clinical visit. After a washout of >24 hours, the participants then will receive the Commercial Native Starch in a fasting state in one clinical visit. Receives: Other: Commercial native starch without processing; Other: Modified starch with extrusion processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glycemia
Incremental area under the curve for blood glucose over 120 minutes.
Measured: -5 to 120 minutes after intervention administration
Secondary outcomes (1)
Incremental Blood Glucose
Change in blood glucose from baseline at each time point
Measured: 0, 15, 30, 45, 60, 90, and 120 minutes after intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 Oct 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glycemic ResponseStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- INQUIS Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Saskatchewan
- Responsible party
- Sponsor
- Investigators
- Thomas MS Wolever, MD, PhD, DM (Oxon), Principal investigator, INQUIS Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048978
- Sponsor's protocol ID
- INQ-2330
- Status last verified
- Apr 2025
- First submitted
- 15 Sep 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng F, Sun G, Li X, Warkentin TD, Ai Y. Novel hydrothermal modification to alter functionality and reduce glycemic response of pea starch. Carbohydr Polym. 2025 Jan 15;348(Pt B):122861. doi: 10.1016/j.carbpol.2024.122861. Epub 2024 Oct 16.
PubMed 39567113
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Starch Processing on Postprandial Blood Glucose in Humans
- ClinicalTrials.gov ID
- NCT06048978
- Acronym / sponsor ID
- INQ-2330
- Conditions
- Glycemic Response
- Keywords
- Postprandial Glycemia, Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- INQUIS Clinical ResearchIndustry (pharma, biotech, devices)
- Collaborators
- University of Saskatchewan
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 21 Sep 2023 (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 determine the postprandial glycemic response of the two starches in humans. Participants will be asked to consume 2 test foods on 2 separate occasions and provide blood glucose samples over 120 minutes postprandial.
Detailed description
Enrolled participants who are generally healthy and free of major chronic conditions will be randomized to receive either Commercial Native Starch or Extrusion Processed Starch first and then will be crossed over to receive the opposite Intervention. The study will consist of two clinical test visits of 120 minutes separated by a washout period of at least 24 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Native Starch, then Processed Starch | Experimental | Other: Commercial native starch without processing, Other: Modified starch with extrusion processingParticipants will first receive the Commercial Native Starch in a fasting state in one clinical visit. After a washout of >24 hours, the participants will then receive the Extrusion Processed Starch in a fasting state in one clinical visit. |
| Processed Starch, then Native Starch | Experimental | Other: Commercial native starch without processing, Other: Modified starch with extrusion processingParticipants will first receive the Extrusion Processed Starch in a fasting state in one clinical visit. After a washout of >24 hours, the participants then will receive the Commercial Native Starch in a fasting state in one clinical visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult males or non-pregnant females.
- eligible to receive income in Canada.
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 |
|---|---|---|
| Commercial native starch without processingA food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption. | Other | Native Starch, then Processed Starch, Processed Starch, then Native Starch |
| Modified starch with extrusion processingA food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption. | Other | Native Starch, then Processed Starch, Processed Starch, then Native Starch |
Primary outcome
Postprandial Glycemia
Time frame: -5 to 120 minutes after intervention administration
Incremental area under the curve for blood glucose over 120 minutes.
1 secondary outcome
Incremental Blood Glucose
Time frame: 0, 15, 30, 45, 60, 90, and 120 minutes after intervention administration
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 1 May 2025.
- Derived from this study: PubMed 39567113Cheng F, Sun G, Li X, Warkentin TD, Ai Y. Novel hydrothermal modification to alter functionality and reduce glycemic response of pea starch. Carbohydr Polym. 2025 Jan 15;348(Pt B):122861. doi: 10.1016/j.carbpol.2024.122861. Epub 2024 Oct 16.
- Individual participant dataSharing planned: No
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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 MS Wolever, MD, PhD, DM (Oxon) 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 Commercial native starch without processing and Modified starch with extrusion processing in people with Glycemic Response, 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 2 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 1 May 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. 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?
Postprandial Glycemia (time frame: -5 to 120 minutes after intervention administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06048978, which also lists 1 linked publication.
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 1 May 2025.