Phenolic-rich Oats and Artery Improvement (PROGRAIN2)

Acute Cardiovascular Effects of Phenolic Rich Oats in Men With Above Average Blood Pressure

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Oat; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Reading, United Kingdom, RG66AP
    • Hugh Sinclair Unit of Human Nutrition
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AP
      • Hugh Sinclair Unit of Human Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

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. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oat intervention; 67.7g oatflake and 22.5g oatbran concentrate - single intake (mixed with water)	Other: Oat; The study oat intervention products will consist of 67.7g oatflake and 22.5g oatbran concentrate.
Placebo Comparator: Control; 39.4g cream of rice, 6.1g sunflower oil, 29.5g skimmed milk, 5.6g pectin powder, 6.5g cellulose and mixed with water	Other: Control; 60g cream of rice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow Mediated Dilatation	Technique to assess the flexibility of the endothelium in larger peripheral blood vessels	1 hour, 6 hours and 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser Doppler Iontophoresis	Acute postprandial timecourse from Baseline to 2 hours, 24hours, AUC - area under the blood flow and time curve Ach-iAUC-endothelium dependent incremental area under the curve SNP-iAUC-endothelium independent incremental area under the curve Ach-AUC- endothelium dependent area under the curve	Baseline(BL), 2hours and 24hours
Phenolic Acids Metabolites - Ferulic Acid	Concentration of phenolic acid metabolites in plasma and urine as Assessed by liquid chromatography/mass spectrometry magnitude of increase from Baseline to 24h	Baseline, 1hour, 2 hours and 24hours
Plasma Nitric Oxide Analysis	Concentration of nitric oxide in nmol	Acute postprandial timecourse from Baseline, 1hour to 24hours.
NADPH Oxidase Activity in Neutrophil Blood Cells	NADPH oxidase activity will be calculated as the difference between values obtained in PMA The fluorescence intensity was measured by C6 Flow Cytometer	Baseline, 2 hours and 24 hours
Plasma Glucose	Glucose concentration in mmol/L	Acute postprandial timecourse from Baseline, 1hour to 24hours.
Plasma Insulin	Insulin concentration in pmol/L	Acute postprandial timecourse from Baseline, 1hour to 24hours.
Renin Activity	Renin activity in ng/(mL*hour)	Acute postprandial timecourse from Baseline, 1hour to 24hours.

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: Biotechnology and Biological Sciences Research Council; PepsiCo Global R&D; University of Roehampton; Rothamsted Research
• Investigators: Principal Investigator: Jeremy P Spencer, Professor, University of Reading

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 13, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Oats; FMD; Phenolic acid; Avenanthramide; LDI
• Other Study ID Numbers: PROGRAIN2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No