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

NCT07427654 | Completed

• 1 other identifier: PEP-2510
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

corn; whole grain; refined; iAUC

Outcome Measures

Primary Outcomes (1)

• iAUC (incremental area under the curve)

  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 Outcomes (3)

• Glycemic Index (GI)

  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)

  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

  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

Study Arms (4)

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.

Other: Dextrose control

Control food

ACTIVE COMPARATOR

Refined corn snack, served with 250 ml water

Other: Corn snack containing 25 grams available carbohydrate

Test food A

EXPERIMENTAL

Whole grain corn snack, manufacturer A, served with 250 ml water

Other: Corn snack containing 25 grams available carbohydrate

Test food B

EXPERIMENTAL

Whole grain corn snack, manufacturer B, served with 250 ml water

Other: Corn snack containing 25 grams available carbohydrate

Interventions

Corn snack containing 25 grams available carbohydrate OTHER

Varying amounts of whole-grain corn from none to some to more

Control food; Test food A; Test food B

Dextrose control OTHER

A solution containing 25g of available carbohydrates on 2 separate occasions

Dextrose control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

INQUIS Clinical Research

Toronto, Ontario, M5C 2N8, Canada

Location

MeSH Terms

Conditions

Callosities

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thomas MS Wolever, MD, PhD

  INQUIS Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 23, 2026
• Study Start: January 8, 2026
• Primary Completion: March 12, 2026
• Study Completion: March 12, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)