Clinical trial NCT02847312: Chronic Cardiovascular and Gut-bacteria Effects of Phenolic Rich Oats in Adults With Above Average Blood Pressure
Official title: Chronic Cardiovascular and Gut-bacteria Effects of Phenolic Rich Oats in Adults With Above Average Blood Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Oat
Phenolic acid
Avenanthramide
FMD
LDI
Gut microbiota
Blood Pressure
Renin Angiotensin
Nitric Oxide
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: PepsiCo, Inc.
name: Rothamsted Research
name: Biotechnology and Biological Sciences Research Council
First posted: 2016-07-28
Enrollment: 30
Sex: ALL
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 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.

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. 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)

Primary outcomes:
measure: Flow mediated dilatation
timeFrame: 20 weeks
Secondary outcomes:
measure: Laser Doppler Iontophoresis
timeFrame: 20 weeks
measure: Gut microbiota changes
timeFrame: 22 weeks
measure: Plasma nitric oxide analysis
timeFrame: 22 weeks
measure: NADPH oxidase activity in neutrophil blood cells
timeFrame: 22 weeks
measure: Inflammatory markers
timeFrame: 22 weeks
measure: Renin activity
timeFrame: 22 weeks
measure: Plasma microparticles
timeFrame: 22 weeks
measure: Urine and plasma metabolomic footprint using NMR
timeFrame: 22 weeks
Other outcomes:
measure: Plasma glucose
timeFrame: 22 weeks
measure: Plasma insulin
timeFrame: 22 weeks
measure: Plasma lipids
timeFrame: 22 weeks
measure: Faecal water metabolites
timeFrame: 22 weeks
Locations:
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: