Phenolic-rich Oats and Artery Improvement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acute Cardiovascular Effects of Phenolic Rich Oats in Men With Above Average Blood Pressure

Conditions
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Healthy

Intervention / Treatment
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* Other: Oat
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above average blood pressure (i.e. systolic 120-159 mmHg and diastolic 75-99 mmHg) Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oat intervention<br>67.7g oatflake and 22.5g oatbran concentrate - single intake (mixed with water) | Other: Oat<br>* The study oat intervention products will consist of 67.7g oatflake and 22.5g oatbran concentrate.<br>|
| Placebo Comparator: Control<br>39.4g cream of rice, 6.1g sunflower oil, 29.5g skimmed milk, 5.6g pectin powder, 6.5g cellulose and mixed with water | Other: Control<br>* 60g cream of rice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Mediated Dilatation | Technique to assess the flexibility of the endothelium in larger peripheral blood vessels | 1 hour, 6 hours and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline, 1hour, 2 hours and 24hours | 
| Plasma Nitric Oxide Analysis | Concentration of nitric oxide in nmol | 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 | Baseline, 2 hours and 24 hours | 
| Plasma Glucose | Glucose concentration in mmol/L | Acute postprandial timecourse from Baseline, 1hour to 24hours. | 
| Plasma Insulin | Insulin concentration in pmol/L | Acute postprandial timecourse from Baseline, 1hour to 24hours. | 
| Renin Activity | Renin activity in ng/(mL*hour) | Acute postprandial timecourse from Baseline, 1hour to 24hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMD, Oats, Phenolic acid, LDI, Avenanthramide