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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02615444
• Other study ID #: QueenMUsz
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 5, 2015
• Last updated: September 26, 2016
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Queen Margaret University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Beta-glucan enriched oatcake
5 oatcakes enriched with oat beta-glucan will be consumed daily for six weeks
• Isocaloric control
6.5 wheat based control snacks without beta-glucan will be consumed daily for six weeks

Locations

Country	Name	City	State
United Kingdom	Queen Margaret University, Edinburgh	Musselburgh	East Lothain

Sponsors (1)

Lead Sponsor	Collaborator
Queen Margaret University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Howarth NC, Saltzman E, Roberts SB. Dietary fiber and weight regulation. Nutr Rev. 2001 May;59(5):129-39. Review. — View 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. — View Citation

Lissner L, Lindroos AK, Sjöström L. Swedish obese subjects (SOS): an obesity intervention study with a nutritional perspective. Eur J Clin Nutr. 1998 May;52(5):316-22. Review. — View Citation

Pouliot MC, Després 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist Circumference		6 weeks	No
Secondary	Blood Pressure		6 Weeks	No
Secondary	Fasting Serum Triglycerides		6 weeks	No
Secondary	Oral Glucose Tolerance Test		6 weeks	No
Secondary	Fasting Serum HDL Cholesterol		6 Weeks	No
Secondary	Fasting Serum total Cholesterol		6 weeks	No
Secondary	Interleukin-6		6 weeks	No
Secondary	Energy Intakes (kilocalories) and Macronutrient intakes (grams) from food diaries		6 weeks	No