Metabolic Syndrome XNCT02615444
The Effects of Beta-glucan Enriched Oatcake Consumption on Metabolic Disease Risk Factors
A study testing Beta-glucan enriched oatcake in people with Metabolic Syndrome X and Cardiovascular Diseases, run by Queen Margaret University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X, Cardiovascular Diseases
- What is being tested?
- Beta-glucan enriched oatcake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Margaret University, Edinburgh
Musselburgh, East Lothain, EH21 6UU
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Syndrome X, Cardiovascular Diseases
- Being tested
- Beta-glucan enriched oatcake, Isocaloric control
- Keywords
- Metabolic Syndrome X, Overweight, Waist Circumference, Blood Pressure, Cholesterol, Oat beta glucan
- Medical subject headings
- Metabolic Syndrome, Cardiovascular Diseases, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-glucan enriched oatcakeDietary supplement
5 oatcakes enriched with oat beta-glucan will be consumed daily for six weeks
Isocaloric controlDietary supplement
6.5 wheat based control snacks without beta-glucan will be consumed daily for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Beta-glucan enriched oatcake | Experimental | Oatcakes which have been enriched with beta-glucan. Each participant will consume 5 oatcakes daily in order to ingest 4g of oat-beta glucan. Receives: Dietary Supplement: Beta-glucan enriched oatcake |
| Isocaloric control | Placebo comparator | 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. Receives: Dietary Supplement: Isocaloric control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist Circumference
Measured: 6 weeks
Secondary outcomes (7)
Blood Pressure
Measured: 6 Weeks
Fasting Serum Triglycerides
Measured: 6 weeks
Oral Glucose Tolerance Test
Measured: 6 weeks
Fasting Serum HDL Cholesterol
Measured: 6 Weeks
Fasting Serum total Cholesterol
Measured: 6 weeks
Interleukin-6
Measured: 6 weeks
Energy Intakes (kilocalories) and Macronutrient intakes (grams) from food diaries
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Zaremba, Queen Margaret University
- Investigators
- Suzanne Zaremba, Study chair, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615444
- Sponsor's protocol ID
- QueenMUsz
- Status last verified
- Sep 2016
- First submitted
- 5 Nov 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8141087Lissner 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.
PubMed 9630380Howarth 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.
PubMed 11396693Liatis 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.
PubMed 19230737
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02615444
- Acronym / sponsor ID
- QueenMUsz
- Conditions
- Metabolic Syndrome X, Cardiovascular Diseases
- Keywords
- Metabolic Syndrome X, Overweight, Waist Circumference, Blood Pressure, Cholesterol, Oat beta glucan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-glucan enriched oatcake | Experimental | Dietary Supplement: Beta-glucan enriched oatcakeOatcakes which have been enriched with beta-glucan. Each participant will consume 5 oatcakes daily in order to ingest 4g of oat-beta glucan. |
| Isocaloric control | Placebo comparator | Dietary Supplement: Isocaloric controlControl: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Postmenopausal females
- Smokers
- Individuals who suffer from, or taking medication for, cardiovascular or gastro-intestinal disease
- Impaired glucose tolerance/Diabetes mellitus
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-glucan enriched oatcake5 oatcakes enriched with oat beta-glucan will be consumed daily for six weeks | Dietary supplement | Beta-glucan enriched oatcake |
| Isocaloric control6.5 wheat based control snacks without beta-glucan will be consumed daily for six weeks | Dietary supplement | Isocaloric control |
Primary outcome
Waist Circumference
Time frame: 6 weeks
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Background: PubMed 8141087Pouliot 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.
- Background: PubMed 9630380Lissner 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.
- Background: PubMed 11396693Howarth 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.
- Background: PubMed 19230737Liatis 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.
Related trials for Metabolic Syndrome X
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 1/2
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Obesity, Metabolic Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Zaremba study chair
Queen Margaret University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-glucan enriched oatcake in people with Metabolic Syndrome X and Cardiovascular Diseases, run by Queen Margaret University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist Circumference (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02615444, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.