Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Viscous dietary fibers including oat β-glucan are one of the most effective classes of functional food ingredients for reducing postprandial blood glucose. The mechanism of action is thought to be via an increase in viscosity of the stomach contents that delays gastric emptying and reduces mixing of food with digestive enzymes, which, in turn, retards glucose absorption. Previous studies suggest that taking viscous fibers separate from a meal may not be effective in reducing postprandial glycemia. The purpose of this study is to re-assess the effect of consuming a preload of a commercially available oat-bran (4.5, 13.6 or 27.3 g) containing 22% of high molecular weight oat β-glucan (O22) mixed in water before a test-meal of white bread on glycemic responses in 10 healthy humans.

Official Title
-----------------
Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study

Conditions
-----------------
Glucose Intolerance

Intervention / Treatment
-----------------
* Other: 0 grams oat bran
* Other: 4.5 grams oat bran
* Other: 13.6 grams oat bran
* Other: 27.3 grams oat bran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Pregnancy Diabetes Recent medical or surgical hospitalization Use of drugs influencing glucose metabolism Use of drugs influencing gastrointestinal function Allergy to oats or wheat

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study subjects<br>Each healthy subject will receive each of the interventions in randomized order. | Other: 0 grams oat bran<br>* 200 milliliters water plus 0 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread<br>Other: 4.5 grams oat bran<br>* 200 milliliters water plus 4.5 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread<br>Other: 13.6 grams oat bran<br>* 200 milliliters water plus 13.6 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread<br>Other: 27.3 grams oat bran<br>* 200 milliliters water plus 27.3 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose AUC | Incremental area under the blood glucose response curve from 0 hours (fasting) to 2 hours after eating ignoring area below fasting | 0 to 2 hours after test meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak rise of blood glucose | Highest concentration of blood glucose within 2 hours of eating minus the fasting glucose concentration | 0 to 2 hours after test meal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Humans, Glycemic response, Oat beta-glucan