Healthy
Conditions
Keywords
Oat, Phenolic acid, Avenanthramide, FMD, LDI, Gut microbiota, Blood Pressure, Renin Angiotensin, Nitric Oxide
Brief 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 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.
Interventions
OTHERHigh avenanthramide, phenolic acid
High avenanthramide and high phenolic acid, matched with energy and insoluable fibre.
OTHERLow avenanthramide, medium phenolic acid
Low avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre.
OTHERControl
Control are matched with energy and insoluable fibre.
Sponsors
PepsiCo, Inc.
Rothamsted Research
Biotechnology and Biological Sciences Research Council
University of Reading
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow mediated dilatation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma nitric oxide analysis | 22 weeks | Concentration of nitric oxide in nmol from Baseline to 4weeks treatment |
| Inflammatory markers | 22 weeks | Inflammatory marker levels change from Baseline to 4weeks treatment |
| Renin activity | 22 weeks | Renin activity in ng/(mL\*hour) |
| Plasma microparticles | 22 weeks | Microparticles in counts/uL |
| Urine and plasma metabolomic footprint using NMR | 22 weeks | — |
| Laser Doppler Iontophoresis | 20 weeks | Magnitude of increase from Baseline to 4weeks treatment |
| Gut microbiota changes | 22 weeks | Gut microbiota diversity and relative abduance change from Baseline to 4weeks treatment |
| NADPH oxidase activity in neutrophil blood cells | 22 weeks | NADPH oxidase activity will be calculated as the difference between values obtained in PMA from Baseline to 4weeks treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma lipids | 22 weeks | Plasma lipid concentration in mmol/L |
| Faecal water metabolites | 22 weeks | Metabolites in mikrogram/L |
| Plasma glucose | 22 weeks | Glucose concentration in mmol/L |
| Plasma insulin | 22 weeks | Insulin concentration in uU/mL |
Countries
United Kingdom
Contacts
Primary ContactJeremy P Spencer, Professor
Backup ContactManuel Y Schar, PDRA
Outcome results
None listed