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Completed

NCT Number: NCT02731755

Phenolic-rich Oats and Artery Improvement

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.

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Key information

Conditions

Healthy

Age range

25 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hugh Sinclair Unit of Human Nutrition, Reading, Berkshire, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oat

Other

The study oat intervention products will consist of 67.7g oatflake and 22.5g oatbran concentrate.

Control

Other

60g cream of rice

Primary outcomes

  1. Flow Mediated Dilatation

    Time frame: 1 hour, 6 hours and 24 hours

    Technique to assess the flexibility of the endothelium in larger peripheral blood vessels

Secondary outcomes

  1. Laser Doppler Iontophoresis

    Time frame: Baseline(BL), 2hours and 24hours

    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

  2. Phenolic Acids Metabolites - Ferulic Acid

    Time frame: Baseline, 1hour, 2 hours and 24hours

    Concentration of phenolic acid metabolites in plasma and urine as Assessed by liquid chromatography/mass spectrometry magnitude of increase from Baseline to 24h

  3. Plasma Nitric Oxide Analysis

    Time frame: Acute postprandial timecourse from Baseline, 1hour to 24hours.

    Concentration of nitric oxide in nmol

  4. NADPH Oxidase Activity in Neutrophil Blood Cells

    Time frame: Baseline, 2 hours and 24 hours

    NADPH oxidase activity will be calculated as the difference between values obtained in PMA The fluorescence intensity was measured by C6 Flow Cytometer

  5. Plasma Glucose

    Time frame: Acute postprandial timecourse from Baseline, 1hour to 24hours.

    Glucose concentration in mmol/L

  6. Plasma Insulin

    Time frame: Acute postprandial timecourse from Baseline, 1hour to 24hours.

    Insulin concentration in pmol/L

  7. Renin Activity

    Time frame: Acute postprandial timecourse from Baseline, 1hour to 24hours.

    Renin activity in ng/(mL*hour)

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Biotechnology and Biological Sciences Research Council
  • PepsiCo Global R&D
  • Rothamsted Research
  • University of Roehampton

Registry information

Official study title

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

Acronym: PROGRAIN2

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2016
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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