NCT02847312

Brief Summary

In this proposed human trial, the investigators aim to establish whether 4 weeks of daily consumption of beta-glucan matched meals providing either a high dose or a moderate dose of oat avenanthramides and phenolic acids leads to dose-dependent chronic improvements in markers of CVD risk and gut health relative to an energy matched control intervention in healthy adults with above average blood pressure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

July 25, 2016

Last Update Submit

July 27, 2016

Conditions

Healthy

Keywords

OatPhenolic acidAvenanthramideFMDLDIGut microbiotaBlood PressureRenin AngiotensinNitric Oxide

Outcome Measures

Primary Outcomes (1)

  • Flow mediated dilatation

    Technique to assess the flexibility of teh endothelium in larger peripheral blood vessels, magnitude of increase in percentage from baseline to after 4 weeks treatment.

    20 weeks

Secondary Outcomes (8)

  • Laser Doppler Iontophoresis

    20 weeks

  • Gut microbiota changes

    22 weeks

  • Plasma nitric oxide analysis

    22 weeks

  • NADPH oxidase activity in neutrophil blood cells

    22 weeks

  • Inflammatory markers

    22 weeks

  • +3 more secondary outcomes

Other Outcomes (4)

  • Plasma glucose

    22 weeks

  • Plasma insulin

    22 weeks

  • Plasma lipids

    22 weeks

  • +1 more other outcomes

Study Arms (3)

High avenanthramide, phenolic acid

ACTIVE COMPARATOR

66.8g Pepsico Oatmeal + 60g Oat cake

Other: High avenanthramide, phenolic acid

Low avenanthramide, medium phenolic acid

ACTIVE COMPARATOR

17g Oatwell + 63.6g Cream of Rice + 60g Melba Toast

Other: Low avenanthramide, medium phenolic acid

Control

PLACEBO COMPARATOR

69.8g Cream of Rice + 8.1g Cellulose + 4.8g Pectin + 60g Melba Toast

Other: Control

Interventions

High avenanthramide, phenolic acidOTHER

High avenanthramide and high phenolic acid, matched with energy and insoluable fibre.

High avenanthramide, phenolic acid
Low avenanthramide, medium phenolic acidOTHER

Low avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre.

Low avenanthramide, medium phenolic acid
ControlOTHER

Control are matched with energy and insoluable fibre.

Control

Eligibility Criteria

Age25 Years - 75 Years
Sexall
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. SBP/DBP ≥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, 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
  • Chronic constipation, diarrhea or other chronic gastrointestinal complaint
  • On a weight reduction regime or taking food, probiotics or prebiotics supplements or laxative within 3 months of trial start
  • Performing high level of physical activity (i.e. ≥150min aerobic exercise/week)
  • Consumption of ≥21 units of alcohol/week
  • Females who are breast-feeding, may be pregnant, lactating or, if of reproductive age and not using a reliable form of contraception (including abstinence)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition

Reading, RG66AP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gyrate Atrophy

Interventions

phenolic acid

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesChoroid DiseasesUveal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jeremy P Spencer, Professor

    University of Reading

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy P Spencer, Professor

CONTACT

+44 (0) 118 378 8724j.p.e.spencer@rdg.ac.uk

Manuel Y Schar, PDRA

CONTACT

+44 (0) 1183786394m.y.schar@reading.ac.uk

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

July 25, 2016

First Posted

July 28, 2016

Study Start

July 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

July 28, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Publish

Locations

GB(1)