HealthyPROGRAIN2NCT02731755
Phenolic-rich Oats and Artery Improvement
A study testing Oat in people with Healthy, run by University of Reading at 2 sites in United Kingdom.
Trial summary
In this proposed human trial, the investigators aim to establish whether consumption of one portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h post-intake) in markers of cardiovascular disease risk relative to an energy matched control intervention in healthy men with high-normal to mildly… Read more about this study
- Who is it for?
- Ages 25 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- 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. systolic/diastolic blood pressure ≥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, gastrointestinal, haematological, neurological, thyroidal disease or cancer
- Prescribed or taking lipid lowering, antihypertensive, vasoactive (e.g. Viagra), anti-inflammatory, antibiotic or antidepressant medication
- Allergies to whole grains
Show all 12Show fewer
- Parallel participation in another research project
- Having flu vaccination or antibiotics within 3 months of trial start
- On a weight reduction regime or taking food supplements within 3 months of trial start
- Performing high level of physical activity (i.e. >3 x 20 min aerobic exercise/week)
- Consumption of ≥21 units of alcohol/week
- Small veins not allowing cannulation
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Hugh Sinclair Unit of Human Nutrition
Reading, Berkshire, RG6 6AP
Hugh Sinclair Unit of Human Nutrition
Reading, RG66AP
About this study
Official title: Acute Cardiovascular Effects of Phenolic Rich Oats in Men With Above Average Blood Pressure
In this proposed human trial, the investigators aim to establish whether consumption of one portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h post-intake) in markers of cardiovascular disease risk relative to an energy matched control intervention in healthy men with high-normal to mildly elevated blood pressure.
Read the detailed description
A diet rich in whole grain is inversely associated with cardiovascular disease risk. Whole grains contain a wide range dietary components including potentially vasoactive phenolic acids.
- Conditions
- Healthy
- Being tested
- Oat, Control
- Keywords
- Oats, Phenolic acid, FMD, LDI, Avenanthramide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OatOther
The study oat intervention products will consist of 67.7g oatflake and 22.5g oatbran concentrate.
ControlOther
60g cream of rice
| Study group | Role | What they receive |
|---|---|---|
| Oat intervention | Active comparator | 67.7g oatflake and 22.5g oatbran concentrate - single intake (mixed with water) Receives: Other: Oat |
| Control | Placebo comparator | 39.4g cream of rice, 6.1g sunflower oil, 29.5g skimmed milk, 5.6g pectin powder, 6.5g cellulose and mixed with water 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 the endothelium in larger peripheral blood vessels
Measured: 1 hour, 6 hours and 24 hours
Secondary outcomes (7)
Laser Doppler Iontophoresis
Acute postprandial timecourse from Baseline to 2 hours, 24hours, AUC - area under the blood flow and time curve Ach-iAUC-endothelium dependent incremental area under the curve SNP-iAUC-endothelium independent incremental area under the curve Ach-AUC- endothelium dependent area under the curve
Measured: Baseline(BL), 2hours and 24hours
Phenolic Acids Metabolites - Ferulic Acid
Concentration of phenolic acid metabolites in plasma and urine as Assessed by liquid chromatography/mass spectrometry magnitude of increase from Baseline to 24h
Measured: Baseline, 1hour, 2 hours and 24hours
Plasma Nitric Oxide Analysis
Concentration of nitric oxide in nmol
Measured: Acute postprandial timecourse from Baseline, 1hour to 24hours.
NADPH Oxidase Activity in Neutrophil Blood Cells
NADPH oxidase activity will be calculated as the difference between values obtained in PMA The fluorescence intensity was measured by C6 Flow Cytometer
Measured: Baseline, 2 hours and 24 hours
Plasma Glucose
Glucose concentration in mmol/L
Measured: Acute postprandial timecourse from Baseline, 1hour to 24hours.
Plasma Insulin
Insulin concentration in pmol/L
Measured: Acute postprandial timecourse from Baseline, 1hour to 24hours.
Renin Activity
Renin activity in ng/(mL*hour)
Measured: Acute postprandial timecourse from Baseline, 1hour to 24hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Rothamsted Research, PepsiCo Global R&D, University of Roehampton
- 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
- NCT02731755
- Sponsor's protocol ID
- PROGRAIN2
- Acronym
- PROGRAIN2
- Status last verified
- Oct 2019
- First submitted
- 9 Feb 2016
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cardiovascular Effects of Phenolic Rich Oats in Men With Above Average Blood Pressure
- ClinicalTrials.gov ID
- NCT02731755
- Acronym / sponsor ID
- PROGRAIN2 / PROGRAIN2
- Conditions
- Healthy
- Keywords
- Oats, Phenolic acid, FMD, LDI, Avenanthramide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Rothamsted Research, PepsiCo Global R&D, University of Roehampton
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Posted 1 Nov 2019
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 consumption of one portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h post-intake) in markers of cardiovascular disease risk relative to an energy matched control intervention in healthy men with high-normal to mildly elevated blood pressure.
Detailed description
A diet rich in whole grain is inversely associated with cardiovascular disease risk. Whole grains contain a wide range dietary components including potentially vasoactive phenolic acids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oat intervention | Active comparator | Other: Oat67.7g oatflake and 22.5g oatbran concentrate - single intake (mixed with water) |
| Control | Placebo comparator | Other: Control39.4g cream of rice, 6.1g sunflower oil, 29.5g skimmed milk, 5.6g pectin powder, 6.5g cellulose and mixed with water |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Male only
- 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 (12 listed)
- Abnormal biochemical, haematological results as assessed at health screening
- Hypertension (i.e. systolic/diastolic blood pressure ≥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, gastrointestinal, haematological, neurological, thyroidal disease or cancer
- Prescribed or taking lipid lowering, antihypertensive, vasoactive (e.g. Viagra), anti-inflammatory, antibiotic or antidepressant medication
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 |
|---|---|---|
| OatThe study oat intervention products will consist of 67.7g oatflake and 22.5g oatbran concentrate. | Other | Oat intervention |
| Control60g cream of rice | Other | Control |
Primary outcome
Flow Mediated Dilatation
Time frame: 1 hour, 6 hours and 24 hours
Technique to assess the flexibility of the endothelium in larger peripheral blood vessels
7 secondary outcomes
Laser Doppler Iontophoresis
Time frame: Baseline(BL), 2hours and 24hours
Phenolic Acids Metabolites - Ferulic Acid
Time frame: Baseline, 1hour, 2 hours and 24hours
Plasma Nitric Oxide Analysis
Time frame: Acute postprandial timecourse from Baseline, 1hour to 24hours.
NADPH Oxidase Activity in Neutrophil Blood Cells
Time frame: Baseline, 2 hours and 24 hours
Plasma Glucose
Time frame: Acute postprandial timecourse from Baseline, 1hour to 24hours.
Plasma Insulin
Time frame: Acute postprandial timecourse from Baseline, 1hour to 24hours.
Renin Activity
Time frame: Acute postprandial timecourse from Baseline, 1hour to 24hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oat in people with Healthy, run by University of Reading at 2 sites 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 12 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 1 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Flow Mediated Dilatation (time frame: 1 hour, 6 hours and 24 hours). 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 1 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.