Cardiovascular DiseaseNCT01925365
Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease
A study testing wholegrain cereals oats (WGO) and Non wholegrain cereals in people with Cardiovascular Disease and Hypercholesterolemia, run by University of Reading at 1 site in United Kingdom.
Trial summary
Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia and heart disease, however the mechanisms by which oats or oat fractions exert this effect is not totally clear. Read more about this study
- Who is it for?
- Ages 23 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Hypercholesterolemia
- What is being tested?
- wholegrain cereals oats (WGO) and Non wholegrain cereals
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to May 2010
- 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 23 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and Women (age range 23-64 y)
- BMI of 18-30kg/m2
- Fasting glucose concentration >5.5 but <7.5mmol/L
- Total cholesterol >5.2 but <7.8mmol/L
Who cannot join
- medical history of heart disease, diabetes mellitus, cancer, pancreatitis or renal disease
- use of lipid lowering drugs, systemic corticosteroids or drugs for regulating hemostasis
- exposure to any investigational agent <42 d before the study
- presence of gastrointestinal disorder or use of a drug likely to alter gastrointestinal motility or nutrient absorption
- history of substance misuse or alcoholism
- current pregnancy, planned pregnancy, or given birth in the past 12 months
Show all 9Show fewer
- antibiotic treatment 6 weeks previous to study start date
- allergy or intolerance to intervention breakfast cereals components
- smoking
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP
About this study
Official title: Hypocholesterolaemic and Prebiotic Effects of a Whole-grain Oat-based Breakfast Cereal in a Cardio-metabolic 'at Risk' Population
Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia and heart disease, however the mechanisms by which oats or oat fractions exert this effect is not totally clear. Furthermore, several large epidemiological studies and a number of recent meta-analyses of nutritional interventions have reported a positive association between increased whole grain intake and reduced risk of developing a range of chronic diseases. Recognising the important role of the gut microbiota in metabolism and metabolic disease risk, we examined the impact of whole grain oats on the human gut microbiota and cardio-metabolic risk factors.
The main aims of this human study is to determine the effectiveness of a low GI whole grain oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and inflammation markers in an at risk of cardio-metabolic disease population
- Conditions
- Cardiovascular Disease, Hypercholesterolemia
- Being tested
- wholegrain cereals oats (WGO), Non wholegrain cereals
- Medical subject headings
- Cardiovascular Diseases, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wholegrain cereals oats (WGO)Dietary supplement
Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period
Non wholegrain cerealsDietary supplement
Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
| Study group | Role | What they receive |
|---|---|---|
| Wholegrain cereal oats | Experimental | Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period. Receives: Dietary Supplement: wholegrain cereals oats (WGO) |
| Non wholegrain cereals | Placebo comparator | Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period. Receives: Dietary Supplement: Non wholegrain cereals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in faecal bacteria population
Measured: Changes in faecal bacteria populations upon consumption of the test and control cereals . Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days
Secondary outcomes (2)
Faecal short chain fatty acids
Measured: High-performance liquid chromatography (HPLC) was performed to determine faecal SCFA concentration. Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days
Changes in plasma lipids
Measured: Fasted plasma samples were analysed for determination of triacylglycerol (TAG), total cholesterol (TC), HDL-cholesterol, LDL-cholesterol. Blood plasma samples were collected and analysed at 0, 42, 56, 112, 140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Jordans Cereals (Biggleswade, UK)
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Prof. Julie A Lovegrove, BSc, PhD, RNutr, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925365
- Sponsor's protocol ID
- UREC 09/12
- Other IDs
- University of Reading
- Status last verified
- Aug 2013
- First submitted
- 15 Aug 2013
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Connolly ML, Lovegrove JA, Tuohy KM. In vitro evaluation of the microbiota modulation abilities of different sized whole oat grain flakes. Anaerobe. 2010 Oct;16(5):483-8. doi: 10.1016/j.anaerobe.2010.07.001. Epub 2010 Jul 17.
PubMed 20624475Connolly ML, Tuohy KM, Lovegrove JA. Wholegrain oat-based cereals have prebiotic potential and low glycaemic index. Br J Nutr. 2012 Dec 28;108(12):2198-206. doi: 10.1017/S0007114512000281. Epub 2012 Feb 24.
PubMed 22360862Connolly ML, Tzounis X, Tuohy KM, Lovegrove JA. Hypocholesterolemic and Prebiotic Effects of a Whole-Grain Oat-Based Granola Breakfast Cereal in a Cardio-Metabolic "At Risk" Population. Front Microbiol. 2016 Nov 7;7:1675. doi: 10.3389/fmicb.2016.01675. eCollection 2016.
PubMed 27872611
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypocholesterolaemic and Prebiotic Effects of a Whole-grain Oat-based Breakfast Cereal in a Cardio-metabolic 'at Risk' Population
- ClinicalTrials.gov ID
- NCT01925365
- Acronym / sponsor ID
- UREC 09/12
- Conditions
- Cardiovascular Disease, Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Jordans Cereals (Biggleswade, UK)
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Aug 2013 (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.
Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia and heart disease, however the mechanisms by which oats or oat fractions exert this effect is not totally clear. Furthermore, several large epidemiological studies and a number of recent meta-analyses of nutritional interventions have reported a positive association between increased whole grain intake and reduced risk of developing a range of chronic diseases. Recognising the important role of the gut microbiota in metabolism and metabolic disease risk, we examined the impact of whole grain oats on the human gut microbiota and cardio-metabolic risk factors.
The main aims of this human study is to determine the effectiveness of a low GI whole grain oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and inflammation markers in an at risk of cardio-metabolic disease population
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wholegrain cereal oats | Experimental | Dietary Supplement: wholegrain cereals oats (WGO)Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period. |
| Non wholegrain cereals | Placebo comparator | Dietary Supplement: Non wholegrain cerealsVolunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period. |
Who may qualify
- Ages
- 23 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and Women (age range 23-64 y)
- BMI of 18-30kg/m2
- Fasting glucose concentration >5.5 but <7.5mmol/L
- Total cholesterol >5.2 but <7.8mmol/L
Key exclusion criteria (9 listed)
- medical history of heart disease, diabetes mellitus, cancer, pancreatitis or renal disease
- use of lipid lowering drugs, systemic corticosteroids or drugs for regulating hemostasis
- exposure to any investigational agent <42 d before the study
- presence of gastrointestinal disorder or use of a drug likely to alter gastrointestinal motility or nutrient absorption
- history of substance misuse or alcoholism
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 |
|---|---|---|
| wholegrain cereals oats (WGO)Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period | Dietary supplement | Wholegrain cereal oats |
| Non wholegrain cerealsVolunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period. | Dietary supplement | Non wholegrain cereals |
Primary outcome
Changes in faecal bacteria population
Time frame: Changes in faecal bacteria populations upon consumption of the test and control cereals . Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days
2 secondary outcomes
Faecal short chain fatty acids
Time frame: High-performance liquid chromatography (HPLC) was performed to determine faecal SCFA concentration. Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days
Changes in plasma lipids
Time frame: Fasted plasma samples were analysed for determination of triacylglycerol (TAG), total cholesterol (TC), HDL-cholesterol, LDL-cholesterol. Blood plasma samples were collected and analysed at 0, 42, 56, 112, 140 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
- Results publication: PubMed 20624475Connolly ML, Lovegrove JA, Tuohy KM. In vitro evaluation of the microbiota modulation abilities of different sized whole oat grain flakes. Anaerobe. 2010 Oct;16(5):483-8. doi: 10.1016/j.anaerobe.2010.07.001. Epub 2010 Jul 17.
- Results publication: PubMed 22360862Connolly ML, Tuohy KM, Lovegrove JA. Wholegrain oat-based cereals have prebiotic potential and low glycaemic index. Br J Nutr. 2012 Dec 28;108(12):2198-206. doi: 10.1017/S0007114512000281. Epub 2012 Feb 24.
- Derived from this study: PubMed 27872611Connolly ML, Tzounis X, Tuohy KM, Lovegrove JA. Hypocholesterolemic and Prebiotic Effects of a Whole-Grain Oat-Based Granola Breakfast Cereal in a Cardio-Metabolic "At Risk" Population. Front Microbiol. 2016 Nov 7;7:1675. doi: 10.3389/fmicb.2016.01675. eCollection 2016.
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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.
Prof. Julie A Lovegrove, BSc, PhD, RNutr principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wholegrain cereals oats (WGO) and Non wholegrain cereals in people with Cardiovascular Disease and Hypercholesterolemia, run by University of Reading 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 19 Aug 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in faecal bacteria population (time frame: Changes in faecal bacteria populations upon consumption of the test and control cereals . Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days). 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 NCT01925365, which also lists 3 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 19 Aug 2013.