Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response

Study Overview
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Brief Summary
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The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response. The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.

Official Title
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Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response

Conditions
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Blood Glucose Response

Intervention / Treatment
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* Other: Reference Product
* Other: Wholegrain product Dose A
* Other: Wholegrain product Dose B
* Other: Wholegrain product Dose A, cut kernels


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female, 35 to 65 years of age BMI 18.5-29.9 kg/m2 Agree to maintain consistent dietary habits and physical activity levels for the duration of the study. Healthy as determined by medical history and information provided by the volunteer. Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits. Has given voluntary, written, informed consent to participate in the study. Exclusion Criteria: Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4) Women who are pregnant or breast feeding Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician. Known Type I or Type II diabetes, including women who previously have had gestational diabetes. Use of antibiotics within 2 weeks of enrollment Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.) Allergy to ingredients included in investigational product, reference, or standardized meal Participants restricted to a vegetarian or vegan diet Intolerance to gluten Individuals who are averse to venous catheterization or capillary blood sampling Currently active smokers (or using other tobacco products, and e-cigarettes) Unstable medical conditions as determined by QI Participation in other clinical research trials Individuals who are cognitively impaired and/or who are unable to give informed consent Acute infection Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual -

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Reference<br> | Other: Reference Product<br>* This intervention is based on white rice.<br>|
| Active Comparator: Whole cereal kernels Dose A<br> | Other: Wholegrain product Dose A<br>* This wholegrain intervention contains whole cereal kernels.<br>|
| Active Comparator: Whole cereal kernels Dose B<br> | Other: Wholegrain product Dose B<br>* This wholegrain intervention contains whole cereal kernels.<br>|
| Active Comparator: Cut cereal kernels Dose A<br> | Other: Wholegrain product Dose A, cut kernels<br>* This wholegrain intervention contains cut cereal kernels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial capillary blood glucose iAUC (0-120 min) | The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial capillary blood glucose Cmax | The change in capillary blood glucose between wholegrain products and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. | 
| Postprandial capillary blood glucose Tmax | The change in capillary blood glucose between wholegrain products and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. | 
| Fasting capillary blood glucose | The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference. | Outcome measures will be assessed just before the standardized meal is consumed. | 
| Postprandial capillary blood glucose iAUC (0-60 min) | The change in capillary blood glucose between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. | 
| Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value) | The change in capillary blood glucose between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. | 
| Postprandial Insulin iAUC(0-120 min) | The change in venous blood insulin between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. | 
| Postprandial Insulin Cmax | The change in venous blood insulin between wholegrain products and reference in Cmax after the standardized breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. | 
| Postprandial Insulin Tmax | The change in venous blood insulin between wholegrain products and reference in Tmax after the standardized breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. | 
| Fasting Insulin | The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. | 
| Postprandial insulin iAUC (0-60 min) | The change in venous blood insulin between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. | 
| Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value) | The change in venous blood insulin between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. |