Clinical trial NCT02615444: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome X
Cardiovascular Diseases
Keywords: Metabolic Syndrome X
Overweight
Waist Circumference
Blood Pressure
Cholesterol
Oat beta glucan
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Waist Circumference
timeFrame: 6 weeks
Secondary outcomes:
measure: Blood Pressure
timeFrame: 6 Weeks
measure: Fasting Serum Triglycerides
timeFrame: 6 weeks
measure: Oral Glucose Tolerance Test
timeFrame: 6 weeks
measure: Fasting Serum HDL Cholesterol
timeFrame: 6 Weeks
measure: Fasting Serum total Cholesterol
timeFrame: 6 weeks
measure: Interleukin-6
timeFrame: 6 weeks
measure: Energy Intakes (kilocalories) and Macronutrient intakes (grams) from food diaries
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Musselburgh
country: United Kingdom
facility: Queen Margaret University, Edinburgh
state: East Lothain
Study officials:
affiliation: Queen Margaret University
name: Suzanne Zaremba
role: STUDY_CHAIR
References:
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.
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.
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.
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.