Evaluation of Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products

Study Overview
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Brief Summary
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The objective of this study is to investigate the effect on postprandial glycaemia in a healthy population after intake of milk and oat based products.

Detailed Description
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Postprandial glycaemia, insulinaemia and GLP-1 will be measured after intake of test meals with equal amount of carbohydrates (adjusted using bread) and equal amount of total water.

Official Title
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A Randomized, Single-blind, Crossover Study to Evaluate Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products

Conditions
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Healthy

Intervention / Treatment
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* Other: Bread reference
* Other: Product 1: Milk
* Other: Product 2: Full fat milk + oat
* Other: Product 3: Skim milk + oat, high fibre
* Other: Product 4: Skim milk + oat, low fibre


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 20 to 40 years of age BMI 20-27 (±0.5) 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 (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5) Elevated fasting insulin (above 25 mIE/L) 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 SI 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 SI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless 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, placebo or standardized meal Participants restricted to a vegetarian or vegan diet Intolerance to lactose or 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 SI 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 SI'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: 20 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Bread reference<br>A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread. | Other: Bread reference<br>* Commercially available white wheat bread<br>Other: Product 1: Milk<br>* Developed reference product based on milk<br>Other: Product 2: Full fat milk + oat<br>* Developed product based on full fat milk with addition of oat<br>Other: Product 3: Skim milk + oat, high fibre<br>* Developed product based on skim milk with addition of oat giving a high fiber content to the product<br>Other: Product 4: Skim milk + oat, low fibre<br>* Developed product based on skim milk with addition of oat giving a lower fiber content to the product<br>|
| Experimental: Product 1: Milk<br>A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk. | Other: Bread reference<br>* Commercially available white wheat bread<br>Other: Product 1: Milk<br>* Developed reference product based on milk<br>Other: Product 2: Full fat milk + oat<br>* Developed product based on full fat milk with addition of oat<br>Other: Product 3: Skim milk + oat, high fibre<br>* Developed product based on skim milk with addition of oat giving a high fiber content to the product<br>Other: Product 4: Skim milk + oat, low fibre<br>* Developed product based on skim milk with addition of oat giving a lower fiber content to the product<br>|
| Experimental: Product 2: Full fat milk + oat<br>A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on full fat milk and oat with high fiber content. | Other: Bread reference<br>* Commercially available white wheat bread<br>Other: Product 1: Milk<br>* Developed reference product based on milk<br>Other: Product 2: Full fat milk + oat<br>* Developed product based on full fat milk with addition of oat<br>Other: Product 3: Skim milk + oat, high fibre<br>* Developed product based on skim milk with addition of oat giving a high fiber content to the product<br>Other: Product 4: Skim milk + oat, low fibre<br>* Developed product based on skim milk with addition of oat giving a lower fiber content to the product<br>|
| Experimental: Product 3: Skim milk + oat, high fibre<br>A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with high fiber content. | Other: Bread reference<br>* Commercially available white wheat bread<br>Other: Product 1: Milk<br>* Developed reference product based on milk<br>Other: Product 2: Full fat milk + oat<br>* Developed product based on full fat milk with addition of oat<br>Other: Product 3: Skim milk + oat, high fibre<br>* Developed product based on skim milk with addition of oat giving a high fiber content to the product<br>Other: Product 4: Skim milk + oat, low fibre<br>* Developed product based on skim milk with addition of oat giving a lower fiber content to the product<br>|
| Experimental: Product 4: Skim milk + oat, low fibre<br>A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with low fiber content. | Other: Bread reference<br>* Commercially available white wheat bread<br>Other: Product 1: Milk<br>* Developed reference product based on milk<br>Other: Product 2: Full fat milk + oat<br>* Developed product based on full fat milk with addition of oat<br>Other: Product 3: Skim milk + oat, high fibre<br>* Developed product based on skim milk with addition of oat giving a high fiber content to the product<br>Other: Product 4: Skim milk + oat, low fibre<br>* Developed product based on skim milk with addition of oat giving a lower fiber content to the product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glycaemia capillary | Primary outcome is the difference in the two-hour incremental area under the curve (iAUC (0 - 120 min)) for capillary blood glucose between product 1-4 and the bread reference. | 0-120 min after consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glycaemia intravenous | The difference in the two-hour iAUC (0 - 120 min) for intravenous blood glucose between product 1-4 and the bread reference. | 0-120 min | 
| Postprandial Cmax capillary glucose | The difference in the three-hour Cmax (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference. | 0-180 min | 
| Postprandial Cmax venous glucose | The difference in the three-hour Cmax (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference. | 0-180 min | 
| Postprandial glycaemia capillary | The difference in the three-hour iAUC (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference. | 0-180 min | 
| Postprandial glycaemia venous | The difference in the three-hour iAUC (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference. | 0-180 min | 
| Postprandial glycaemia capillary | The difference in the one-hour iAUC (0 - 60 min) of capillary blood glucose between product 1-4 and the bread reference. | 0-60 min | 
| Postprandial glycaemia venous | The difference in the one-hour iAUC (0 - 60 min) of intravenous blood glucose between product 1-4 and the bread reference. | 0-60 min | 
| Postprandial glycaemia Tmax capillary | The difference in the Tmax (the time to maximum concentration) of capillary blood glucose between product 1-4 and the bread reference. | 0-180 min | 
| Postprandial glycaemia Tmax venous | The difference in the Tmax of intravenous blood glucose between product 1-4 and the bread reference. | 0-180 min | 
| Postprandial insulinaemia | The difference in the three-hour iAUC (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference. | 0-180 min | 
| Postprandial insulinaemia | The difference in the two-hour iAUC (0 - 120 min) of intravenous blood insulin between product 1-4 and the bread reference. | 0-120 min | 
| Postprandial insulinaemia | The difference in the one-hour iAUC (0 - 60 min) of intravenous blood insulin between product 1-4 and the bread reference. | 0-60 min | 
| Postprandial insulinaemia Cmax | The difference in the three-hour Cmax (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference. | 0-180 min | 
| Postprandial insulinaemia Tmax | The difference in the Tmax of intravenous blood insulin between product 1-4 and the bread reference. | 0-180 min | 
| Postprandial GLP-1 bread reference | The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference. | 0-60 min | 
| Postprandial GLP-1, yoghurt control | The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1. | 0-60 min | 
| Postprandial GLP-1 Cmax bread reference | The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference. | 0-60 min | 
| Postprandial GLP-1 Cmax yoghurt control | The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1. | 0-60 min |