Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults

Study Overview
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Brief Summary
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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.

Official Title
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Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults

Conditions
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Healthy Nutrition

Intervention / Treatment
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* Other: Food


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peanut Butter Cereal<br>Consumption of Peanut Butter Cereal | Other: Food<br>* Food<br>|
| Experimental: Cinnamon Almond Cereal<br>Consumption of Cinnamon Almond Cereal | Other: Food<br>* Food<br>|
| Experimental: Sriracha Crisps<br>Consumption of Sriracha Crisps | Other: Food<br>* Food<br>|
| Experimental: Cheddar Crisps<br>Consumption of Cheddar Crisps | Other: Food<br>* Food<br>|
| Experimental: Almond Blueberry Butter Bar<br>Consumption of Almond Blueberry Butter Bar | Other: Food<br>* Food<br>|
| Experimental: Peanut Butter and Dark Chocolate Bar<br>Consumption of Peanut Butter and Dark Chocolate Bar | Other: Food<br>* Food<br>|
| Experimental: Almond Dark Chocolate Bar<br>Consumption of Almond Dark Chocolate Bar | Other: Food<br>* Food<br>|
| Experimental: White Bread 5 g available carbohydrate<br>Consumption of white bread containing 5 g available carbohydrate | Other: Food<br>* Food<br>|
| Active Comparator: White Bread 20 g available carbohydrate<br>Consumption of white bread containing 20 g available carbohydrate | Other: Food<br>* Food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalent glycemic load | 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. | -5 minutes to 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin iAUC over 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. | -5 minutes to 120 minutes | 
| Glucose iAUC over 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. | -5 minutes to 120 minutes |