Determination of the Glycemic Index of Products Varying in Levels of Refined and Whole Grain Corn

March 13, 2026 updated by: PepsiCo Global R&D

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2N8
        • Inquis Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Dextrose control
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.
Other: Dextrose control
A solution containing 25g of available carbohydrates on 2 separate occasions
Active Comparator: Control food
Refined corn snack, served with 250 ml water
Other: Corn snack containing 25 grams available carbohydrate
Varying amounts of whole-grain corn from none to some to more
Experimental: Test food A
Whole grain corn snack, manufacturer A, served with 250 ml water
Other: Corn snack containing 25 grams available carbohydrate
Varying amounts of whole-grain corn from none to some to more
Experimental: Test food B
Whole grain corn snack, manufacturer B, served with 250 ml water
Other: Corn snack containing 25 grams available carbohydrate
Varying amounts of whole-grain corn from none to some to more

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Compare the plasma glucose in mmol/L of three products with varying levels of refined and whole grain corn vs. dextrose control
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
Calculate the GI x (grams available carbohydrate in a serving) where a serving is 28 grams of each of the three corn products
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
Compare glucose levels in mmol/L at individual timepoints after each of three corn products
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PepsiCo Global R&D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas MS Wolever, MD, PhD, INQUIS Clinical Research, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PEP-2510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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