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

Not Applicable

• Conditions: Cardiovascular Diseases; Metabolic Syndrome X
• Interventions: Dietary Supplement: Isocaloric control; Dietary Supplement: Beta-glucan enriched oatcake

• Registration Number: NCT02615444
• Lead Sponsor: Queen Margaret University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isocaloric control	Isocaloric control	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.
Beta-glucan enriched oatcake	Beta-glucan enriched oatcake	Oatcakes which have been enriched with beta-glucan. Each participant will consume 5 oatcakes daily in order to ingest 4g of oat-beta glucan.

Primary Outcome Measures

Name	Time	Method
Waist Circumference	6 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Queen Margaret University, Edinburgh; 🇬🇧 Musselburgh, East Lothain, United Kingdom