Healthy Nutrition
Conditions
Brief summary
The purpose of this study is to test the hypothesis that the equivalent glycemic load (EGL) value of portions of white bread containing 5 g available carbohydrate measured in this study is accurate and precise to within 1 gram. Additionally, the EGL of 7 low carbohydrate foods will be measured to determine their glycemic impact.
Interventions
OTHERFood
Food
Sponsors
INQUIS Clinical Research
General Mills
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18-75 inclusive * 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 * Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator * Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
Exclusion criteria
* Failure to meet any one of the inclusion criteria at screening * Pregnant or lactating individuals * Personal history of diabetes * Major trauma or surgical event within 3 months of screening * The presence of any laboratory result, health condition, illness or drug use that increases risk to the subject or to others or may affect the results, as judged by the Qualified Investigator * Unwillingness or inability to comply with experimental procedures and to follow INQUIS safety guidelines * Known intolerance, sensitivity, or allergy to any ingredients in the study test meals. All allergens should be assumed to be a result of manufacturing practices. * Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement or lifestyle modification
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Equivalent glycemic load | -5 minutes to 120 minutes | Equivalent glycemic load (EGL) for each test food, expressed as \[EGL = T/(W/Cwb)\] where T is the plasma glucose incremental area under the curve over 120 minutes (iAUC) elicited by one serving of test food, W is the mean iAUC elicited by the mean of two WB20 tests and Cwb is the amount of available carbohydrate in the WB20. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin iAUC over 120 minutes | -5 minutes to 120 minutes | Postprandial serum insulin incremental area under the curve over 120 minutes for each food in a subset of n=10 individuals. Blood will be collected at -5, 0, 15, 30, 45, 60, 90, and 120 minutes. |
| Glucose iAUC over 120 minutes | -5 minutes to 120 minutes | Postprandial plasma glucose incremental area under the curve over 120 minutes for each food in n=25 individuals. Blood will be collected at -5, 0, 15, 30, 45, 60, 90, and 120 minutes. |
Countries
Canada
Outcome results
None listed