Health Effects of Oat and Oat Polar Lipids in Human

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods.

Detailed Description
-----------------
The overall goal is to increase the knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on cardiometabolic test markers of oat and oat based product. The new knowledge will form a base for the development of oat based food products with added health values.

Official Title
-----------------
Health Effects of Oat and Oat Bioactive in Human

Conditions
-----------------
Postprandial Glucose Regulation

Intervention / Treatment
-----------------
* Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults BMI 18.5 - 28 Kg/m2 Non smokers Consuming a non-vegetarian diet that follows the Nordic diet recommendation. Exclusion Criteria: Fasting blood glucose concentration >6.1 mmol/l Known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome). Gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. No antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oat product 1<br>The test portion is based on 50 gram available carbohydrates with added vegetable oil A. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. | Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables<br>* Oat and oat bioactive components consumed as breakfast meal.<br>|
| Experimental: Oat product 2<br>The test portion is based on 50 gram available carbohydrates with added vegetable oil B. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. | Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables<br>* Oat and oat bioactive components consumed as breakfast meal.<br>|
| Experimental: Oat product 3<br>The test portion is based on 50 gram available carbohydrates with added vegetable oil C. Test portion consumed as a breakfast meal prior to determinations of test variables in the morning. | Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables<br>* Oat and oat bioactive components consumed as breakfast meal.<br>|
| Placebo Comparator: Control Product<br>The test portion is based on 50 gram available carbohydrates without added vegetable oil. | Combination Product: Effects of Oat and Oat Components on Cardiometabolic risk variables<br>* Oat and oat bioactive components consumed as breakfast meal.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose regulation | Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 5.5 hours after consumption of test products. | 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum insulin | Acute effects of postprandial serum insulin concentrations (incremental area under the curve) after intake of the test products. | 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) | 
| plasma GLP-1 (glucagon-like peptide-1 ) | Gastro-intestinale hormones involved in appetite and metabolic regulation | 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) | 
| Serum triglycerides | Cardiometabolic risk markers | 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) | 
| Serum Free Fatty Acids | Cardiometabolic risk markers | 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) | 
| Plasma PYY (peptide tyrosine tyrosine) | Gastro-intestinale hormones involved in appetite and metabolic regulation | 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) |