Condition category
Respiratory
Date applied
03/07/2015
Date assigned
14/07/2015
Last edited
14/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Despite optimum medical treatment, many patients with lung disease remain significantly disabled. There is evidence that dietary nitrate supplementation can reduce the oxygen needed during exercise but it is not clear if this improves the amount of exercise that a person can do. The purpose of this project is to investigate whether dietary nitrate supplementation in the form of a single dose of beetroot juice can improve the distance that people with lung disease who are dependent on oxygen can walk.

Who can participate?
Adults with lung disease who need to use on oxygen when they walk.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given 140ml of nitrate rich beetroot juice (0.8g nitrate) to drink. Those in group 2 are given 140ml of placebo (nitrate depleted beetroot juice). All participants are then asked to do a walking test (called an “endurance shuttle walk”). How long each participant can walk for and the effects of the nitrate rich beetroot juice on heart rate and amount of oxygen in the blood is recorded.

What are the possible benefits and risks of participating?
The tests used are all part of routine clinical practice and no significant risks are anticipated. As this is a test of a single dose only, no direct benefit to trial participants is expected but they will be helping to advance understanding of exercise ,limitation and this could eventually lead to a novel therapy becoming available for them and others with their condition.

Where is the study run from?
Royal Brompton and Harefield NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2015 to October 2017

Who is funding the study?
Moulton Medical Foundation

Who is the main contact?
Ms Rebecca Tanner
r.tanner@imperial.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Rebecca Tanner

ORCID ID

Contact details

Royal Brompton Hospital
London
SW3 6NP
United Kingdom
02073518029
r.tanner@imperial.ac.uk

Type

Scientific

Additional contact

Dr Nicholas Hopkinson

ORCID ID

http://orcid.org/0000-0003-3235-0454

Contact details

Royal Brompton Hospital
Fulham Rd
London
SW3 6NP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of dietary nitrate on exercise in hypoxia

Acronym

EDEN-OX

Study hypothesis

The purpose of this study is to investigate the effects of an acute administration of beetroot (BR) juice versus placebo beverage ingestion on plasma NO2- levels, blood pressure, exercise tolerance and fractional oxygen extraction in 3 groups of patients
1. COPD patients who are using ambulatory oxygen
2. Interstitial pulmonary Fibrosis (IPF) patients who are using ambulatory oxygen
3. Pulmonary hypertension (PHT) patients who are using ambulatory oxygen

The following hypotheses will be tested:
1. BR would increase plasma NO2- levels (a biomarker of NO production and availability)
2. BR will increase endurance shuttle walk time
3. BR will reduce oxygen desaturation during ESWT (area under SaO2 curve to isotime)
4. BR will reduce heart rate during equivalent exercise (area under HR curve to isotime)

Ethics approval

London-Chelsea Research Ethics Committee, ref: 15/LO/0975

Study design

Series of parallel randomised, double-blind, cross-over, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Lung disease (COPD, pulmonary fibrosis, pulmonary hypertension)

Intervention

140ml of nitrate-rich beetroot juice (containing 12.9mmol nitrate) or nitrate depleted placebo.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

An increase in endurance shuttle walk (ESWT) time breathing oxygen at the patient's customary flow rate.

Secondary outcome measures

1. Area under oxygen saturation curve to isotime during ESWT
2. Area under heart rate curve to isotime during ESWT
3. Resting blood pressure
4. Blood nitrate levels

Overall trial start date

01/10/2015

Overall trial end date

01/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients with GOLD I-IV COPD who require ambulatory oxygen because of exertional desaturation
2. Adult patients with IPF who require ambulatory oxygen because of exertional desaturation
3. Adult patients with pulmonary hypertension who require ambulatory oxygen because of exertional desaturation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60 (20 in each diagnostic group)

Participant exclusion criteria

1. Clinically unstable patients (within one month of exacerbation)
2. Significant comorbidity limiting exercise tolerance
3. Significant renal impairment (estimated glomerular filtration rate (eGFR) <50 ml.min-1)
4. Hypotension (systolic blood pressure <100 mmHg)
5. Pregnancy
6. Use of nitrate based medication or PDE5 inhibitors such as sildenafil

Recruitment start date

01/10/2015

Recruitment end date

01/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton and Harefield NHS Foundation Trust
Fulham Rd
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Imperial College

Sponsor details

Regulatory Compliance
Imperial College London and Imperial College Healthcare NHS Trust
Room 510A
5th floor Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Moulton Medical Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes