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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02847312
• Other study ID #: Prograin3
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2016
• Last updated: July 27, 2016
• Start date: July 2016
• Est. completion date: April 2017

Study information

• Verified date: July 2016
• Source: University of Reading
• Contact: Jeremy P Spencer, Professor
• Phone: +44 (0) 118 378 8724
• Email: j.p.e.spencer[@]rdg.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• High avenanthramide, phenolic acid
High avenanthramide and high phenolic acid, matched with energy and insoluable fibre.
• Low avenanthramide, medium phenolic acid
Low avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre.
• Control
Control are matched with energy and insoluable fibre.

Locations

Country	Name	City	State
United Kingdom	Hugh Sinclair Unit of Human Nutrition	Reading

Sponsors (4)

Lead Sponsor	Collaborator
University of Reading	Biotechnology and Biological Sciences Research Council, PepsiCo, Inc., Rothamsted Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma glucose	Glucose concentration in mmol/L	22 weeks	No
Other	Plasma insulin	Insulin concentration in uU/mL	22 weeks	No
Other	Plasma lipids	Plasma lipid concentration in mmol/L	22 weeks	No
Other	Faecal water metabolites	Metabolites in mikrogram/L	22 weeks	No
Primary	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	No
Secondary	Laser Doppler Iontophoresis	Magnitude of increase from Baseline to 4weeks treatment	20 weeks	No
Secondary	Gut microbiota changes	Gut microbiota diversity and relative abduance change from Baseline to 4weeks treatment	22 weeks	No
Secondary	Plasma nitric oxide analysis	Concentration of nitric oxide in nmol from Baseline to 4weeks treatment	22 weeks	No
Secondary	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	No
Secondary	Inflammatory markers	Inflammatory marker levels change from Baseline to 4weeks treatment	22 weeks	No
Secondary	Renin activity	Renin activity in ng/(mL*hour)	22 weeks	No
Secondary	Plasma microparticles	Microparticles in counts/uL	22 weeks	No
Secondary	Urine and plasma metabolomic footprint using NMR		22 weeks	No