The Effects of Beta-glucan Enriched Oatcake Consumption on Metabolic Disease Risk Factors

Study Overview
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Brief Summary
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The purpose of this study is to determine whether daily consumption of soluble fibre, oat beta glucan (4g), for six weeks will have any impact on overweight/obese individuals in terms of risk factors used to define metabolic disease.

Detailed Description
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The purpose of this study is to determine whether daily consumption oat beta glucan (4g) for six weeks will have any impact on overweight/obese individuals in terms of risk factors used to define metabolic disease. Oat beta-glucan has been incorporated into a novel oatcake product manufactured by Nairn's Oatcakes Ltd. Consumption of the oatcake products will deliver enough oat-beta glucan to the diet to meet European Food Safety Authority health claims for lowering blood cholesterol and reducing post-prandial glycaemic responses.

Official Title
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An Investigation of the Effects of Consuming Oatcakes Containing 4g of Oat Beta-glucan on Physiological Parameters in Individuals at Risk of Developing Metabolic Syndrome

Conditions
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Metabolic Syndrome X, Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Beta-glucan enriched oatcake
* Dietary Supplement: Isocaloric control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females 18 years and older Waist circumference measurements of ≥94cm for males and 80cm for females, or a body mass index of ≥30kg/m2 Individuals who are able to provide informed consent Exclusion Criteria: Postmenopausal females Smokers Individuals who suffer from, or taking medication for, cardiovascular or gastro-intestinal disease Impaired glucose tolerance/Diabetes mellitus Pregnancy or breastfeeding Those who have high dietary fibre intakes (>20g/day) Known food allergies to oats, wheat, lactose, or sesame seeds

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beta-glucan enriched oatcake<br>Oatcakes which have been enriched with beta-glucan. Each participant will consume 5 oatcakes daily in order to ingest 4g of oat-beta glucan. | Dietary Supplement: Beta-glucan enriched oatcake<br>* 5 oatcakes enriched with oat beta-glucan will be consumed daily for six weeks<br>|
| Placebo Comparator: Isocaloric control<br>Control: Wheat based snack, equicaloric and matched to intervention product for macronutrient content. Contains no oat-beta glucan. Each participant will consume 6.5 Krackawheats daily. | Dietary Supplement: Isocaloric control<br>* 6.5 wheat based control snacks without beta-glucan will be consumed daily for six weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist Circumference |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | 6 Weeks | 
| Fasting Serum Triglycerides |  | 6 weeks | 
| Oral Glucose Tolerance Test |  | 6 weeks | 
| Fasting Serum HDL Cholesterol |  | 6 Weeks | 
| Fasting Serum total Cholesterol |  | 6 weeks | 
| Interleukin-6 |  | 6 weeks | 
| Energy Intakes (kilocalories) and Macronutrient intakes (grams) from food diaries |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome X, Overweight, Waist Circumference, Blood Pressure, Cholesterol, Oat beta glucan