HealthyNCT02847312
Chronic Cardiovascular and Gut-bacteria Effects of Phenolic Rich Oats in Adults With Above Average Blood Pressure
A study testing High avenanthramide, phenolic acid and Low avenanthramide, medium phenolic acid in people with Healthy, run by University of Reading at 1 site in United Kingdom.
Trial summary
In this proposed human trial, the investigators aim to establish whether 4 weeks of daily consumption of beta-glucan matched meals providing either a high dose or a moderate dose of oat avenanthramides and phenolic acids leads to dose-dependent chronic improvements in markers of CVD risk and gut health relative to an… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High avenanthramide, phenolic acid and Low avenanthramide, medium phenolic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Apr 2017
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above average blood pressure (i.e. systolic 120-159 mmHg and diastolic 75-99 mmHg)
Who cannot join
- Abnormal biochemical, haematological results as assessed at health screening
- Hypertension (i.e. SBP/DBP ≥160/100 mm Hg)
- BMI >35
- Current smoker or ex-smoker ceasing <3 months ago
- Past or existing medical history of vascular disease, diabetes, hepatic, renal, haematological, neurological, thyroidal disease or cancer
- Prescribed or taking lipid lowering, antihypertensive, vasoactive (e.g. Viagra), anti-inflammatory, antibiotic or antidepressant medication
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- Allergies to whole grains
- Parallel participation in another research project
- Having flu vaccination or antibiotics within 3 months of trial start
- Chronic constipation, diarrhea or other chronic gastrointestinal complaint
- On a weight reduction regime or taking food, probiotics or prebiotics supplements or laxative within 3 months of trial start
- Performing high level of physical activity (i.e. ≥150min aerobic exercise/week)
- Consumption of ≥21 units of alcohol/week
- Females who are breast-feeding, may be pregnant, lactating or, if of reproductive age and not using a reliable form of contraception (including abstinence)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hugh Sinclair Unit of Human Nutrition
Reading, RG66AP
Michelle Weech, Mananger, 01183787771, m.weech@reading.ac.uk
Angelika Kristek, Assistant, 0118378771, a.kristek@reading.ac.uk
About this study
In this proposed human trial, the investigators aim to establish whether 4 weeks of daily consumption of beta-glucan matched meals providing either a high dose or a moderate dose of oat avenanthramides and phenolic acids leads to dose-dependent chronic improvements in markers of CVD risk and gut health relative to an energy matched control intervention in healthy adults with above average blood pressure.
Read the detailed description
- To investigate the chronic effects of daily intake of oat products on flow mediated dilatation of the brachial artery (FMD; primary endpoint), microvascular endothelial function (measured by laser Doppler iontophoresis), pulse wave analysis, gut microbiota diversity, 24h blood pressure, activity of the renin angiotensin system, markers related to cellular production of nitric oxide and reactive oxygen species, inflammatory cytokines, and further potentially emerging biochemical markers of CVD risk.
- To establish if phenolic acids and avenanthramides from oat products exert cardiovascular and microbial effects in a dose dependent manner.
- To measure urinary and fecal excretion of avenanthramide and phenolic acid metabolites.
To explore correlations between bacterial population changes and CVD risk markers.
- Conditions
- Healthy
- Being tested
- High avenanthramide, phenolic acid, Low avenanthramide, medium phenolic acid, Control
- Keywords
- Oat, Phenolic acid, Avenanthramide, FMD, LDI, Gut microbiota, Blood Pressure, Renin Angiotensin, Nitric Oxide
- Medical subject headings
- Gyrate Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High avenanthramide, phenolic acidOther
High avenanthramide and high phenolic acid, matched with energy and insoluable fibre.
Low avenanthramide, medium phenolic acidOther
Low avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre.
ControlOther
Control are matched with energy and insoluable fibre.
| Study group | Role | What they receive |
|---|---|---|
| High avenanthramide, phenolic acid | Active comparator | 66.8g Pepsico Oatmeal + 60g Oat cake Receives: Other: High avenanthramide, phenolic acid |
| Low avenanthramide, medium phenolic acid | Active comparator | 17g Oatwell + 63.6g Cream of Rice + 60g Melba Toast Receives: Other: Low avenanthramide, medium phenolic acid |
| Control | Placebo comparator | 69.8g Cream of Rice + 8.1g Cellulose + 4.8g Pectin + 60g Melba Toast Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilatation
Technique to assess the flexibility of teh endothelium in larger peripheral blood vessels, magnitude of increase in percentage from baseline to after 4 weeks treatment.
Measured: 20 weeks
Secondary outcomes (8)
Laser Doppler Iontophoresis
Magnitude of increase from Baseline to 4weeks treatment
Measured: 20 weeks
Gut microbiota changes
Gut microbiota diversity and relative abduance change from Baseline to 4weeks treatment
Measured: 22 weeks
Plasma nitric oxide analysis
Concentration of nitric oxide in nmol from Baseline to 4weeks treatment
Measured: 22 weeks
NADPH oxidase activity in neutrophil blood cells
NADPH oxidase activity will be calculated as the difference between values obtained in PMA from Baseline to 4weeks treatment
Measured: 22 weeks
Inflammatory markers
Inflammatory marker levels change from Baseline to 4weeks treatment
Measured: 22 weeks
Renin activity
Renin activity in ng/(mL*hour)
Measured: 22 weeks
Plasma microparticles
Microparticles in counts/uL
Measured: 22 weeks
Urine and plasma metabolomic footprint using NMR
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- PepsiCo, Inc., Rothamsted Research, Biotechnology and Biological Sciences Research Council
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy P Spencer, Professor, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847312
- Sponsor's protocol ID
- Prograin3
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publish
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Cardiovascular and Gut-bacteria Effects of Phenolic Rich Oats in Adults With Above Average Blood Pressure
- ClinicalTrials.gov ID
- NCT02847312
- Acronym / sponsor ID
- Prograin3
- Conditions
- Healthy
- Keywords
- Oat, Phenolic acid, Avenanthramide, FMD, LDI, Gut microbiota, Blood Pressure, Renin Angiotensin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- PepsiCo, Inc., Rothamsted Research, Biotechnology and Biological Sciences Research Council
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 28 Jul 2016 (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.
In this proposed human trial, the investigators aim to establish whether 4 weeks of daily consumption of beta-glucan matched meals providing either a high dose or a moderate dose of oat avenanthramides and phenolic acids leads to dose-dependent chronic improvements in markers of CVD risk and gut health relative to an energy matched control intervention in healthy adults with above average blood pressure.
Detailed description
- To investigate the chronic effects of daily intake of oat products on flow mediated dilatation of the brachial artery (FMD; primary endpoint), microvascular endothelial function (measured by laser Doppler iontophoresis), pulse wave analysis, gut microbiota diversity, 24h blood pressure, activity of the renin angiotensin system, markers related to cellular production of nitric oxide and reactive oxygen species, inflammatory cytokines, and further potentially emerging biochemical markers of CVD risk.
- To establish if phenolic acids and avenanthramides from oat products exert cardiovascular and microbial effects in a dose dependent manner.
- To measure urinary and fecal excretion of avenanthramide and phenolic acid metabolites.
To explore correlations between bacterial population changes and CVD risk markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High avenanthramide, phenolic acid | Active comparator | Other: High avenanthramide, phenolic acid66.8g Pepsico Oatmeal + 60g Oat cake |
| Low avenanthramide, medium phenolic acid | Active comparator | Other: Low avenanthramide, medium phenolic acid17g Oatwell + 63.6g Cream of Rice + 60g Melba Toast |
| Control | Placebo comparator | Other: Control69.8g Cream of Rice + 8.1g Cellulose + 4.8g Pectin + 60g Melba Toast |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Above average blood pressure (i.e. systolic 120-159 mmHg and diastolic 75-99 mmHg)
Key exclusion criteria (14 listed)
- Abnormal biochemical, haematological results as assessed at health screening
- Hypertension (i.e. SBP/DBP ≥160/100 mm Hg)
- BMI >35
- Current smoker or ex-smoker ceasing <3 months ago
- Past or existing medical history of vascular disease, diabetes, hepatic, renal, haematological, neurological, thyroidal disease or cancer
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 |
|---|---|---|
| High avenanthramide, phenolic acidHigh avenanthramide and high phenolic acid, matched with energy and insoluable fibre. | Other | High avenanthramide, phenolic acid |
| Low avenanthramide, medium phenolic acidLow avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre. | Other | Low avenanthramide, medium phenolic acid |
| ControlControl are matched with energy and insoluable fibre. | Other | Control |
Primary outcome
Flow mediated dilatation
Time frame: 20 weeks
Technique to assess the flexibility of teh endothelium in larger peripheral blood vessels, magnitude of increase in percentage from baseline to after 4 weeks treatment.
8 secondary outcomes
Laser Doppler Iontophoresis
Time frame: 20 weeks
Gut microbiota changes
Time frame: 22 weeks
Plasma nitric oxide analysis
Time frame: 22 weeks
NADPH oxidase activity in neutrophil blood cells
Time frame: 22 weeks
Inflammatory markers
Time frame: 22 weeks
Renin activity
Time frame: 22 weeks
Plasma microparticles
Time frame: 22 weeks
Urine and plasma metabolomic footprint using NMR
Time frame: 22 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Individual participant dataSharing planned: Yes. Publish
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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.
Jeremy P Spencer, Professor 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 High avenanthramide, phenolic acid and Low avenanthramide, medium phenolic acid in people with Healthy, 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 1 inclusion and 14 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 28 Jul 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?
Contact Jeremy P Spencer, Professor (+44 (0) 118 378 8724 ext. 8724, j.p.e.spencer@rdg.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow mediated dilatation (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2016.