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

NCT ID: NCT02615444

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Syndrome X Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Beta-glucan enriched oatcake

Intervention Type DIETARY_SUPPLEMENT

5 oatcakes enriched with oat beta-glucan will be consumed daily for six weeks

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.

Group Type PLACEBO_COMPARATOR

Isocaloric control

Intervention Type DIETARY_SUPPLEMENT

6.5 wheat based control snacks without beta-glucan will be consumed daily for six weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Beta-glucan enriched oatcake

5 oatcakes enriched with oat beta-glucan will be consumed daily for six weeks

Intervention Type DIETARY_SUPPLEMENT

Isocaloric control

6.5 wheat based control snacks without beta-glucan will be consumed daily for six weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Queen Margaret University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Suzanne Zaremba

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suzanne Zaremba

Role: STUDY_CHAIR

Queen Margaret University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Queen Margaret University, Edinburgh

Musselburgh, East Lothain, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 8141087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9630380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11396693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19230737 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QueenMUsz

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Barley Bread and Metabolic Disease
NCT02867215 COMPLETED NA