Glycemic IndexNCT07427654
Determination of the Glycemic Index of Products Varying in Levels of Refined and Whole Grain Corn
A study testing Corn snack containing 25 grams available carbohydrate in people with Glycemic Index and Glycemic Load, run by PepsiCo Global R&D at 1 site in Canada.
Trial summary
Interest in identifying low GI foods and the food factors responsible for the low GI of foods has increased. Three corn products with varying levels of refined and whole grain corn will be compared to each other and to a dextrose control. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index, Glycemic Load
- What is being tested?
- Corn snack containing 25 grams available carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2026to 12 Mar 2026
- 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
- Adults aged 18-75 years, inclusive.
- BMI between 18.0 and 35.0 Kg/m2.
- Willing to abstain from unusual strenuous exercise and consuming alcoholic drinks for 24 hours before study days.
- Willing to refrain from smoking tobacco or marijuana for 12h before and during study visits.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Understanding the study procedures \& willing to provide informed consent to participate in the study \& authorization to release relevant protected health information to the study investigator.
- Participants must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP.
Who cannot join
- Self-reported pregnant or breastfeeding women.
- Known history of gastrointestinal disease (e.g., diverticulitis, Crohns disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the participant or to others, or 2) affect the results.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the participant or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS health and safety policies.
- Known intolerance, sensitivity or allergy to test products.
- Participation in any clinical trial within the past 30 days (with the exception of routine GI testing of commonly consumed foods) or any PepsiCo sponsored trial within the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Glycemic Index of Products Varying in Levels of Refined and Whole Grain Corn: a Randomized Controlled Trial in Healthy Participants
Interest in identifying low GI foods and the food factors responsible for the low GI of foods has increased. Three corn products with varying levels of refined and whole grain corn will be compared to each other and to a dextrose control. It is hypothesized that higher levels of whole grain corn present in a food will decrease the rate of absorption and result in a lower postprandial glucose levels and glycemic index, and that the whole grain ingredient manufacturing process impacts whole grain ingredient benefits.
- Conditions
- Glycemic Index, Glycemic Load
- Being tested
- Corn snack containing 25 grams available carbohydrate, Dextrose control
- Keywords
- corn, whole grain, refined, iAUC
- Medical subject headings
- Callosities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn snack containing 25 grams available carbohydrateOther
Varying amounts of whole-grain corn from none to some to more
Dextrose controlOther
A solution containing 25g of available carbohydrates on 2 separate occasions
| Study group | Role | What they receive |
|---|---|---|
| Dextrose control | Active comparator | Consumed at two visits (first and last of 5 test days). Solution contains 25g of available carbohydrates (27.3g dextrose monohydrate) mixed with 250 ml of water. Served with 250 ml additional water. Receives: Other: Dextrose control |
| Control food | Active comparator | Refined corn snack, served with 250 ml water Receives: Other: Corn snack containing 25 grams available carbohydrate |
| Test food A | Experimental | Whole grain corn snack, manufacturer A, served with 250 ml water Receives: Other: Corn snack containing 25 grams available carbohydrate |
| Test food B | Experimental | Whole grain corn snack, manufacturer B, served with 250 ml water Receives: Other: Corn snack containing 25 grams available carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
iAUC (incremental area under the curve)
Compare the plasma glucose in mmol/L of three corn products
Measured: Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test snack consumed within 10 minutes
Secondary outcomes (3)
Glycemic Index (GI)
Compare the plasma glucose in mmol/L of three products with varying levels of refined and whole grain corn vs. dextrose control
Measured: Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test snack consumed within 10 minutes
Glycemic load (GL)
Calculate the GI x (grams available carbohydrate in a serving) where a serving is 28 grams of each of the three corn products
Measured: Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test snack consumed within 10 minutes
Incremental glucose levels
Compare glucose levels in mmol/L at individual timepoints after each of three corn products
Measured: Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test corn snack consumed within 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start8 Jan 2026
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic IndexStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, INQUIS Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427654
- Sponsor's protocol ID
- PEP-2510
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2026
- Last updated
- 16 Mar 2026
- Results posted
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Glycemic Index of Products Varying in Levels of Refined and Whole Grain Corn: a Randomized Controlled Trial in Healthy Participants
- ClinicalTrials.gov ID
- NCT07427654
- Acronym / sponsor ID
- PEP-2510
- Conditions
- Glycemic Index, Glycemic Load
- Keywords
- corn, whole grain, refined, iAUC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 23 Feb 2026 (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.
Interest in identifying low GI foods and the food factors responsible for the low GI of foods has increased. Three corn products with varying levels of refined and whole grain corn will be compared to each other and to a dextrose control. It is hypothesized that higher levels of whole grain corn present in a food will decrease the rate of absorption and result in a lower postprandial glucose levels and glycemic index, and that the whole grain ingredient manufacturing process impacts whole grain ingredient benefits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dextrose control | Active comparator | Other: Dextrose controlConsumed at two visits (first and last of 5 test days). Solution contains 25g of available carbohydrates (27.3g dextrose monohydrate) mixed with 250 ml of water. Served with 250 ml additional water. |
| Control food | Active comparator | Other: Corn snack containing 25 grams available carbohydrateRefined corn snack, served with 250 ml water |
| Test food A | Experimental | Other: Corn snack containing 25 grams available carbohydrateWhole grain corn snack, manufacturer A, served with 250 ml water |
| Test food B | Experimental | Other: Corn snack containing 25 grams available carbohydrateWhole grain corn snack, manufacturer B, served with 250 ml water |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18-75 years, inclusive.
- BMI between 18.0 and 35.0 Kg/m2.
- Willing to abstain from unusual strenuous exercise and consuming alcoholic drinks for 24 hours before study days.
- Willing to refrain from smoking tobacco or marijuana for 12h before and during study visits.
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
Key exclusion criteria (7 listed)
- Self-reported pregnant or breastfeeding women.
- Known history of gastrointestinal disease (e.g., diverticulitis, Crohns disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the participant or to others, or 2) affect the results.
- Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the participant or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS health and safety policies.
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 |
|---|---|---|
| Corn snack containing 25 grams available carbohydrateVarying amounts of whole-grain corn from none to some to more | Other | Control food, Test food A, Test food B |
| Dextrose controlA solution containing 25g of available carbohydrates on 2 separate occasions | Other | Dextrose control |
Primary outcome
iAUC (incremental area under the curve)
Time frame: Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test snack consumed within 10 minutes
Compare the plasma glucose in mmol/L of three corn products
3 secondary outcomes
Glycemic Index (GI)
Time frame: Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test snack consumed within 10 minutes
Glycemic load (GL)
Time frame: Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test snack consumed within 10 minutes
Incremental glucose levels
Time frame: Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test corn snack consumed within 10 minutes
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 16 Mar 2026.
- 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 principal investigator
INQUIS Clinical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corn snack containing 25 grams available carbohydrate in people with Glycemic Index and Glycemic Load, run by PepsiCo Global R&D 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 7 inclusion and 7 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 16 Mar 2026. 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?
iAUC (incremental area under the curve) (time frame: Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test snack consumed within 10 minutes). 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 16 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.