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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference | Placebo Comparator |
| |
| Whole cereal kernels Dose A | Active Comparator |
| |
| Whole cereal kernels Dose B | Active Comparator |
| |
| Cut cereal kernels Dose A | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference Product | Other | This intervention is based on white rice. |
| |
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting GLP-1 | The change in fasting GLP-1 the morning after consuming either wholegrain products or reference. | Outcome measures will be assessed just before the standardized meal is consumed. |
| GLP-1 iAUC(0-120 min) |
Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aventure AB | Lund | Sweden |
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| Wholegrain product Dose A |
| Other |
This wholegrain intervention contains whole cereal kernels. |
|
| Wholegrain product Dose B | Other | This wholegrain intervention contains whole cereal kernels. |
|
| Wholegrain product Dose A, cut kernels | Other | This wholegrain intervention contains cut cereal kernels. |
|
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. |
The change in GLP-1 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. |
| GLP-1 iAUC(0-60 min) | The change in GLP-1 between wholegrain products and reference in the1-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. |
| GLP-1 Cmax | The changein GLP-1 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. |
| GLP-1 Tmax | The change in GLP-1 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 PYY | The change in fasting PYY the morning after consuming either wholegrain products or reference. | Outcome measures will be assessed just before the standardized meal is consumed. |
| PYY 2-hour mean concentration | The change in PYY between the wholegrain products and the reference in the 2-hour mean concentration after the breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. |
| PYY 1-hour mean concentration | The change in PYY between the wholegrain products and the reference in the 1-hour mean concentration after the breakfast meal. | Outcome measures will be assessed just before and immediately after the standardized meal is consumed. |