Does beetroot juice improve walking in people with lung disease and low oxygen levels?
| ISRCTN | ISRCTN14888729 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14888729 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/07/2015
- Registration date
- 14/07/2015
- Last edited
- 18/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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 oxygen when they walk.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given 140 ml of nitrate-rich beetroot juice (0.8 g nitrate) to drink. Those in group 2 are given 140 ml 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 July 2024
Who is funding the study?
Moulton Medical Foundation (Guernsey)
Who is the main contact?
Mansour Majrshi, m.majrshi22@imperial.ac.uk
Contact information
Public
Respiratory Muscle Lab
National Heart and Lung Institute
Royal Brompton Campus
Guy Scadding Building
Dovehouse St
London
SW3 6LY
United Kingdom
| Phone | +44 (0)2073518029 |
|---|---|
| m.majrshi22@imperial.ac.uk |
Scientific
Royal Brompton Hospital
Fulham Rd
London
SW3 6NP
United Kingdom
 ORCID ID |
0000-0003-3235-0454 |
|---|
Study information
| Study design | Series of parallel randomised, double-blind, cross-over, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effect of dietary nitrate on exercise in hypoxia |
| Study acronym | EDEN-OX |
| Study objectives | Current hypothesis as of 11/01/2023: 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 4 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 4. Adults with a history of COVID-19 and persisting breathlessness at least 3 months following the acute illness and evidence of pulmonary vascular abnormalities 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) _____ Previous 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(s) | London-Chelsea Research Ethics Committee, ref: 15/LO/0975 |
| Health condition(s) or problem(s) studied | Patients with lung disease (COPD, interstitial pulmonary fibrosis, pulmonary hypertension) who require ambulatory oxygen because of exertional desaturation and adults with a history of COVID-19 and persisting breathlessness at least 3 months following the acute illness and evidence of pulmonary vascular abnormalities |
| Intervention | 140 ml of nitrate-rich beetroot juice (containing 12.9 mmol nitrate) or nitrate-depleted placebo. |
| Intervention type | Supplement |
| Primary outcome measure | 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 study start date | 01/10/2015 |
| Completion date | 01/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | Current inclusion criteria as of 18/07/2023: 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 4. Adults with a history of COVID-19 and persisting breathlessness at least 3 months following the acute illness and evidence of pulmonary vascular abnormalities (abnormal gas transfer defined as a TLco <lower limit of normal) _____ Previous inclusion criteria as of 11/01/2023: 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 4. Adults with a history of COVID-19 and persisting breathlessness at least 3 months following the acute illness and evidence of pulmonary vascular abnormalities _____ Previous 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 |
| Key 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 |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 01/06/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW3 6NP
United Kingdom
Sponsor information
University/education
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
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | The deidentified datasets generated during the current study will be available indefinitely to researchers upon request to Professor Nicholas Hopkinson (n.hopkinson@ic.ac.uk) once the results have been published in a scientific journal. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results for COPD group | 01/12/2021 | 03/12/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
18/07/2023: The participant inclusion criteria have been changed.
11/01/2023: The following changes have been made:
1. The recruitment end date has been changed from 01/09/2017 to 01/06/2024.
2. The study hypothesis has been changed.
3. The condition has been changed from "Patients with lung disease (COPD, interstitial pulmonary fibrosis, pulmonary hypertension) who require ambulatory oxygen because of exertional desaturation" to "Patients with lung disease (COPD, interstitial pulmonary fibrosis, pulmonary hypertension) who require ambulatory oxygen because of exertional desaturation and adults with a history of COVID-19 and persisting breathlessness at least 3 months following the acute illness and evidence of pulmonary vascular abnormalities".
4. The participant inclusion criteria have been changed.
5. The public contact's details have been updated.
6. The overall trial end date has been changed from 01/10/2017 to 01/07/2024 and the plain English summary updated accordingly.
7. The intention to publish date has been changed from to.
8. The IPD sharing statement has been added.
28/12/2022: The following changes have been made:
1. The target number of participants has been changed from 60 to 90.
2. The public contact has been changed and the plain English summary updated accordingly.
03/12/2021: Publication reference added.
