NCT02731755

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 1, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

February 9, 2016

Results QC Date

September 22, 2019

Last Update Submit

October 13, 2019

Conditions

Healthy

Keywords

OatsPhenolic acidFMDLDIAvenanthramide

Outcome Measures

Primary Outcomes (1)

  • Flow Mediated Dilatation

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

    1 hour, 6 hours and 24 hours

Secondary Outcomes (7)

  • Laser Doppler Iontophoresis

    Baseline(BL), 2hours and 24hours

  • Phenolic Acids Metabolites - Ferulic Acid

    Baseline, 1hour, 2 hours and 24hours

  • Plasma Nitric Oxide Analysis

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

  • NADPH Oxidase Activity in Neutrophil Blood Cells

    Baseline, 2 hours and 24 hours

  • Plasma Glucose

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

  • +2 more secondary outcomes

Study Arms (2)

Oat intervention

ACTIVE COMPARATOR

67.7g oatflake and 22.5g oatbran concentrate - single intake (mixed with water)

Other: Oat

Control

PLACEBO COMPARATOR

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

Interventions

OatOTHER

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

Oat intervention
ControlOTHER

60g cream of rice

Control

Eligibility Criteria

Age25 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales with above average blood pressure
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above average blood pressure (i.e. systolic 120-159 mmHg and diastolic 75-99 mmHg)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hugh Sinclair Unit of Human Nutrition

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Hugh Sinclair Unit of Human Nutrition

Reading, RG66AP, United Kingdom

Location

MeSH Terms

Interventions

Ornithine-Oxo-Acid Transaminase

Intervention Hierarchy (Ancestors)

TransaminasesNitrogenous Group TransferasesTransferasesEnzymesEnzymes and Coenzymes

Results Point of Contact

Title
Prof Jeremy Spencer
Organization
University of Reading
j.p.e.spencer@reading.ac.uk
+44(0) 1183788724

Study Officials

  • Jeremy P Spencer, Professor

    University of Reading

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2016

First Posted

April 8, 2016

Study Start

January 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 1, 2019

Results First Posted

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)