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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2016

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Waist Circumference
    • Time Frame: 6 weeks

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Queen Margaret University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Suzanne Zaremba, PhD Student – Queen Margaret University
  • Overall Official(s)
    • Suzanne Zaremba, Study Chair, Queen Margaret University

References

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.

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.

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

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.

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