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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: High avenanthramide, phenolic acid; Other: Low avenanthramide, medium phenolic acid; Other: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy P Spencer, Professor; Phone Number: 8724 +44 (0) 118 378 8724; Email: j.p.e.spencer@rdg.ac.uk
• Study Contact Backup: Name: Manuel Y Schar, PDRA; Phone Number: +44 (0) 1183786394; Email: m.y.schar@reading.ac.uk

Study Locations

• United Kingdom
  • Reading, United Kingdom, RG66AP
    • Recruiting
    • Hugh Sinclair Unit of Human Nutrition
    • Contact: Michelle Weech, Mananger; Phone Number: 01183787771; Email: m.weech@reading.ac.uk
    • Contact: Angelika Kristek, Assistant; Phone Number: 0118378771; Email: a.kristek@reading.ac.uk
    • Sub-Investigator: Manuel Y Schar, PDRA
    • Principal Investigator: Jeremy P Spencer, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High avenanthramide, phenolic acid; 66.8g Pepsico Oatmeal + 60g Oat cake	Other: High avenanthramide, phenolic acid; High avenanthramide and high phenolic acid, matched with energy and insoluable fibre.
Active Comparator: Low avenanthramide, medium phenolic acid; 17g Oatwell + 63.6g Cream of Rice + 60g Melba Toast	Other: Low avenanthramide, medium phenolic acid; Low avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre.
Placebo Comparator: Control; 69.8g Cream of Rice + 8.1g Cellulose + 4.8g Pectin + 60g Melba Toast	Other: Control; Control are matched with energy and insoluable fibre.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose	Glucose concentration in mmol/L	22 weeks
Plasma insulin	Insulin concentration in uU/mL	22 weeks
Plasma lipids	Plasma lipid concentration in mmol/L	22 weeks
Faecal water metabolites	Metabolites in mikrogram/L	22 weeks

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: Biotechnology and Biological Sciences Research Council; PepsiCo, Inc.; Rothamsted Research
• Investigators: Principal Investigator: Jeremy P Spencer, Professor, University of Reading

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Gut microbiota; Blood Pressure; Nitric Oxide; Oat; FMD; Phenolic acid; Avenanthramide; LDI; Renin Angiotensin
• Other Study ID Numbers: Prograin3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publish