Glycemic Index, Glycemic Load
Conditions
Keywords
corn, whole grain, refined, iAUC
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.
Interventions
OTHERCorn snack containing 25 grams available carbohydrate
Varying amounts of whole-grain corn from none to some to more
OTHERDextrose control
A solution containing 25g of available carbohydrates on 2 separate occasions
Sponsors
PepsiCo Global R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iAUC (incremental area under the curve) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Compare the plasma glucose in mmol/L of three products with varying levels of refined and whole grain corn vs. dextrose control |
| 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 | Calculate the GI x (grams available carbohydrate in a serving) where a serving is 28 grams of each of the three corn products |
| 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 | Compare glucose levels in mmol/L at individual timepoints after each of three corn products |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORThomas MS Wolever, MD, PhD
INQUIS Clinical Research, Inc.
Outcome results
None listed