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Phenolic-rich Oats and Artery Improvement (PROGRAIN2)

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University of Reading

Status

Completed

Conditions

Healthy

Treatments

Other: Control
Other: Oat

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02731755
PROGRAIN2

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

Male

Ages

25 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

18 participants in 2 patient groups, including a placebo group

Oat intervention
Active Comparator group
Description:
67.7g oatflake and 22.5g oatbran concentrate - single intake (mixed with water)
Treatment:
Other: Oat
Control
Placebo Comparator group
Description:
39.4g cream of rice, 6.1g sunflower oil, 29.5g skimmed milk, 5.6g pectin powder, 6.5g cellulose and mixed with water
Treatment:
Other: Control

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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