Clinical trial NCT02731755: Phenolic-rich Oats and Artery Improvement
Official title: Acute Cardiovascular Effects of Phenolic Rich Oats in Men With Above Average Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Oats
Phenolic acid
FMD
LDI
Avenanthramide
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Biotechnology and Biological Sciences Research Council
name: Rothamsted Research
name: PepsiCo Global R&D
name: University of Roehampton
First posted: 2016-04-08
Enrollment: 18
Sex: MALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Flow Mediated Dilatation
timeFrame: 1 hour, 6 hours and 24 hours
Secondary outcomes:
measure: Laser Doppler Iontophoresis
timeFrame: Baseline(BL), 2hours and 24hours
measure: Phenolic Acids Metabolites - Ferulic Acid
timeFrame: Baseline, 1hour, 2 hours and 24hours
measure: Plasma Nitric Oxide Analysis
timeFrame: Acute postprandial timecourse from Baseline, 1hour to 24hours.
measure: NADPH Oxidase Activity in Neutrophil Blood Cells
timeFrame: Baseline, 2 hours and 24 hours
measure: Plasma Glucose
timeFrame: Acute postprandial timecourse from Baseline, 1hour to 24hours.
measure: Plasma Insulin
timeFrame: Acute postprandial timecourse from Baseline, 1hour to 24hours.
measure: Renin Activity
timeFrame: Acute postprandial timecourse from Baseline, 1hour to 24hours.
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Hugh Sinclair Unit of Human Nutrition
state: Berkshire
city: Reading
country: United Kingdom
facility: Hugh Sinclair Unit of Human Nutrition
Study officials:
affiliation: University of Reading
name: Jeremy P Spencer, Professor
role: PRINCIPAL_INVESTIGATOR
References: