Glycemic Response
Conditions
Keywords
Postprandial Glycemia, Blood Glucose
Brief summary
The goal of this clinical trial is to determine the postprandial glycemic response of the two starches in humans. Participants will be asked to consume 2 test foods on 2 separate occasions and provide blood glucose samples over 120 minutes postprandial.
Detailed description
Enrolled participants who are generally healthy and free of major chronic conditions will be randomized to receive either Commercial Native Starch or Extrusion Processed Starch first and then will be crossed over to receive the opposite Intervention. The study will consist of two clinical test visits of 120 minutes separated by a washout period of at least 24 hours.
Interventions
OTHERCommercial native starch without processing
A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.
OTHERModified starch with extrusion processing
A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.
Sponsors
University of Saskatchewan
INQUIS Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adult males or non-pregnant females. * eligible to receive income in Canada.
Exclusion criteria
* age less than 18 years * any known food allergies or intolerances to the investigational product * medications known to affect glucose tolerance -but stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable * known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions * any major medical or surgical events requiring hospitalization within the preceding 3 months * the presence of disease or drug(s) which influence digestion and absorption of nutrients * the short-term use of systemic steroids or atypical antipsychotics (\<4 weeks) (all of which have major effects on glucose and metabolism and body fat distribution) * any other medications or conditions which might, in the opinion of the Medical Director of INQUIS Clinical Research Ltd. (INQUIS), either 1) make participation dangerous to the subject or to others, or 2) affect the results * any subject who cannot or will not comply with the experimental procedures or do not follow INQUIS safety guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Glycemia | -5 to 120 minutes after intervention administration | Incremental area under the curve for blood glucose over 120 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incremental Blood Glucose | 0, 15, 30, 45, 60, 90, and 120 minutes after intervention administration | Change in blood glucose from baseline at each time point |
Countries
Canada
Outcome results
None listed