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OpenTrials
Completed

NCT Number: NCT07427654

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INQUIS Clinical Research

Toronto, Ontario, M5C 2N8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Corn snack containing 25 grams available carbohydrate

Other

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

Dextrose control

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

Determination of the Glycemic Index of Products Varying in Levels of Refined and Whole Grain Corn: a Randomized Controlled Trial in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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