Health Effects of Oats and Oat Bioactive 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
-----------------
Effects of Oat and Oat Components on Cardiometabolic- and Cognitive Test Variables

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

Intervention / Treatment
-----------------
* Combination Product: Oat Beverage 1
* Combination Product: Oat Beverage 2
* Combination Product: Oat Beverage 3
* Combination Product: Oat Beverage 4
* Combination Product: Control product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults BMI 18,5 - 25 non smokers consuming a non-vegetarian diet that follows the Nordic guidances 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. Further 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
Interventional Model Description: a randomized blinded cross-over study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control product<br>A glucose solution (glucose and water) based on 42 gram carbohydrates. | Combination Product: Control product<br>* Glucose based beverage without added test components is used as control product<br>|
| Experimental: Oat Beverage 1<br>The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. | Combination Product: Oat Beverage 1<br>* Oat based beverage with added different concentration of extracted oat component.<br>|
| Experimental: Oat Beverage 2<br>The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. | Combination Product: Oat Beverage 2<br>* Oat based beverage with added different concentration of extracted oat component.<br>|
| Experimental: Oat Beverage 3<br>The test product is an oat based beverage with added vegetable oil. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. | Combination Product: Oat Beverage 3<br>* Oat based beverage with added different concentration of extracted oat component.<br>|
| Experimental: Oat Beverage 4<br>The test product is an oat based beverage. The test portion is based on 42 gram available carbohydrates and consumed as a breakfast meal prior to determinations of test variables in the morning. | Combination Product: Oat Beverage 4<br>* Oat based beverage with added different concentration of extracted oat component.<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) | 
| IL (interleukin)-6 | Inflammatory markers in blood | 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) | 
| IL- 1beta | Inflammatory markers in blood | 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch) |