Chronic Cardiovascular and Gut-bacteria Effects of Phenolic Rich Oats in Adults With Above Average Blood Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Chronic Cardiovascular and Gut-bacteria Effects of Phenolic Rich Oats in Adults With Above Average Blood Pressure

Conditions
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Healthy

Intervention / Treatment
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* Other: High avenanthramide, phenolic acid
* Other: Low avenanthramide, medium phenolic acid
* 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. 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 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)

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

Sexes Eligible for Study
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All

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: High avenanthramide, phenolic acid<br>66.8g Pepsico Oatmeal + 60g Oat cake | Other: High avenanthramide, phenolic acid<br>* High avenanthramide and high phenolic acid, matched with energy and insoluable fibre.<br>|
| Active Comparator: Low avenanthramide, medium phenolic acid<br>17g Oatwell + 63.6g Cream of Rice + 60g Melba Toast | Other: Low avenanthramide, medium phenolic acid<br>* Low avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre.<br>|
| Placebo Comparator: Control<br>69.8g Cream of Rice + 8.1g Cellulose + 4.8g Pectin + 60g Melba Toast | Other: Control<br>* Control are matched with energy and insoluable fibre.<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 teh endothelium in larger peripheral blood vessels, magnitude of increase in percentage from baseline to after 4 weeks treatment. | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laser Doppler Iontophoresis | Magnitude of increase from Baseline to 4weeks treatment | 20 weeks | 
| Gut microbiota changes | Gut microbiota diversity and relative abduance change from Baseline to 4weeks treatment | 22 weeks | 
| Plasma nitric oxide analysis | Concentration of nitric oxide in nmol from Baseline to 4weeks treatment | 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 | 22 weeks | 
| Inflammatory markers | Inflammatory marker levels change from Baseline to 4weeks treatment | 22 weeks | 
| Renin activity | Renin activity in ng/(mL*hour) | 22 weeks | 
| Plasma microparticles | Microparticles in counts/uL | 22 weeks | 
| Urine and plasma metabolomic footprint using NMR |  | 22 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oat, Phenolic acid, Avenanthramide, FMD, LDI, Gut microbiota, Blood Pressure, Renin Angiotensin, Nitric Oxide