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
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