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

September 26, 2016 updated by: Suzanne Zaremba, Queen Margaret University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Lothain
      • Musselburgh, East Lothain, United Kingdom, EH21 6UU
        • Queen Margaret University, Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Beta-glucan enriched oatcake
5 oatcakes enriched with oat beta-glucan will be consumed daily for six weeks
Placebo Comparator: 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.
Dietary supplement: Isocaloric control
6.5 wheat based control snacks without beta-glucan will be consumed daily for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Waist Circumference
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Margaret University

Investigators

  • Study Chair: Suzanne Zaremba, Queen Margaret University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QueenMUsz

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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