Phenolic-rich Oats and Artery Improvement

Healthy Clinical Trial

— PROGRAIN2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731755
• Other study ID #: PROGRAIN2
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: November 2016

Study information

• Verified date: October 2019
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• 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. 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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Oat
The study oat intervention products will consist of 67.7g oatflake and 22.5g oatbran concentrate.
• Control
60g cream of rice

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
University of Reading	Biotechnology and Biological Sciences Research Council, PepsiCo Global R&D, Rothamsted Research, University of Roehampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow Mediated Dilatation	Technique to assess the flexibility of the endothelium in larger peripheral blood vessels	1 hour, 6 hours and 24 hours
Secondary	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
Secondary	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
Secondary	Plasma Nitric Oxide Analysis	Concentration of nitric oxide in nmol	Acute postprandial timecourse from Baseline, 1hour to 24hours.
Secondary	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
Secondary	Plasma Glucose	Glucose concentration in mmol/L	Acute postprandial timecourse from Baseline, 1hour to 24hours.
Secondary	Plasma Insulin	Insulin concentration in pmol/L	Acute postprandial timecourse from Baseline, 1hour to 24hours.
Secondary	Renin Activity	Renin activity in ng/(mL*hour)	Acute postprandial timecourse from Baseline, 1hour to 24hours.