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

Primary Purpose

Metabolic Syndrome X, Cardiovascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Beta-glucan enriched oatcake
Isocaloric control
Sponsored by
Queen Margaret University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome X focused on measuring Metabolic Syndrome X, Overweight, Waist Circumference, Blood Pressure, Cholesterol, Oat beta glucan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Queen Margaret University, Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Beta-glucan enriched oatcake

Isocaloric control

Arm Description

Oatcakes which have been enriched with beta-glucan. Each participant will consume 5 oatcakes daily in order to ingest 4g of oat-beta glucan.

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.

Outcomes

Primary Outcome Measures

Waist Circumference

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2015
Last Updated
September 26, 2016
Sponsor
Queen Margaret University
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1. Study Identification

Unique Protocol Identification Number
NCT02615444
Brief Title
The Effects of Beta-glucan Enriched Oatcake Consumption on Metabolic Disease Risk Factors
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Margaret University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X, Cardiovascular Diseases
Keywords
Metabolic Syndrome X, Overweight, Waist Circumference, Blood Pressure, Cholesterol, Oat beta glucan

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beta-glucan enriched oatcake
Arm Type
Experimental
Arm Description
Oatcakes which have been enriched with beta-glucan. Each participant will consume 5 oatcakes daily in order to ingest 4g of oat-beta glucan.
Arm Title
Isocaloric control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-glucan enriched oatcake
Intervention Description
5 oatcakes enriched with oat beta-glucan will be consumed daily for six weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Isocaloric control
Intervention Description
6.5 wheat based control snacks without beta-glucan will be consumed daily for six weeks
Primary Outcome Measure Information:
Title
Waist Circumference
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Blood Pressure
Time Frame
6 Weeks
Title
Fasting Serum Triglycerides
Time Frame
6 weeks
Title
Oral Glucose Tolerance Test
Time Frame
6 weeks
Title
Fasting Serum HDL Cholesterol
Time Frame
6 Weeks
Title
Fasting Serum total Cholesterol
Time Frame
6 weeks
Title
Interleukin-6
Time Frame
6 weeks
Title
Energy Intakes (kilocalories) and Macronutrient intakes (grams) from food diaries
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Zaremba
Organizational Affiliation
Queen Margaret University
Official's Role
Study Chair
Facility Information:
Facility Name
Queen Margaret University, Edinburgh
City
Musselburgh
State/Province
East Lothain
ZIP/Postal Code
EH21 6UU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
8141087
Citation
Pouliot MC, Despres JP, Lemieux S, Moorjani S, Bouchard C, Tremblay A, Nadeau A, Lupien PJ. Waist circumference and abdominal sagittal diameter: best simple anthropometric indexes of abdominal visceral adipose tissue accumulation and related cardiovascular risk in men and women. Am J Cardiol. 1994 Mar 1;73(7):460-8. doi: 10.1016/0002-9149(94)90676-9.
Results Reference
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PubMed Identifier
9630380
Citation
Lissner L, Lindroos AK, Sjostrom L. Swedish obese subjects (SOS): an obesity intervention study with a nutritional perspective. Eur J Clin Nutr. 1998 May;52(5):316-22. doi: 10.1038/sj.ejcn.1600567.
Results Reference
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PubMed Identifier
11396693
Citation
Howarth NC, Saltzman E, Roberts SB. Dietary fiber and weight regulation. Nutr Rev. 2001 May;59(5):129-39. doi: 10.1111/j.1753-4887.2001.tb07001.x.
Results Reference
background
PubMed Identifier
19230737
Citation
Liatis S, Tsapogas P, Chala E, Dimosthenopoulos C, Kyriakopoulos K, Kapantais E, Katsilambros N. The consumption of bread enriched with betaglucan reduces LDL-cholesterol and improves insulin resistance in patients with type 2 diabetes. Diabetes Metab. 2009 Apr;35(2):115-20. doi: 10.1016/j.diabet.2008.09.004. Epub 2009 Feb 20.
Results Reference
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The Effects of Beta-glucan Enriched Oatcake Consumption on Metabolic Disease Risk Factors

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