Effect of dietary nitrate supplementation on exercise performance in chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN66099139 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66099139 |
| Secondary identifying numbers | V1 |
- Submission date
- 11/04/2013
- Registration date
- 22/04/2013
- Last edited
- 04/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Patients with chronic obstructive pulmonary disease (COPD), which is a combination of chronic bronchitis and emphysema, are limited in their daily activates because of breathlessness. However, there is increasing evidence that their muscle function is also reduced which can further limit them, so we are investigating a dietary supplement that may be helpful. Muscle metabolism and blood flow are influenced by a substance called nitric oxide (NO). Levels of this can be influenced by dietary nitrate consumption (found in leafy green vegetables and especially in beetroot). There is evidence that beetroot juice can improve exercise performance in athletes and we want to test whether it will improve exercise performance in people with COPD.
Who can participate?
We will study 25 people with COPD.
What does the study involve?
After baseline assessments of lung function and exercise capacity, patients will perform two maximum exercise tests. One after consuming 70mls of beetroot juice and one after consuming 70mls of beetroot juice treated to remove the nitrate (placebo). They taste identical and patients and researchers will not know which they have consumed. The primary endpoint (or (measure of success) of the study is the time that patients can cycle on a bike in our laboratory at a workload that is 70% of the maximum they can reach. Oxygen consumption and muscle metabolism (using a technique called near infrared spectroscopy) will be assessed. We will take blood samples to monitor the effect of the juice/placebo on nitrate levels.
What are the possible benefits and risks of participating?
The procedures are all routine so no risks are anticipated: If positive, this initial study would lead to a larger research study to evaluate the use of this supplement more widely in patients with COPD.
Where is the study run from?
The study is being performed at The Royal Brompton Hospital and is supported by Imperial College (UK).
When is the study starting and how long is it expected to run for?
It is expected to run from the beginning of May 2013 until the end of 2014.
Who is funding the study?
It is funded from Royal Brompton Hospital Departmental funds (UK).
Who is the main contact?
Dr Nicholas Hopkinson
n.hopkinson@ic.ac.uk
Contact information
Scientific
Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom
 ORCID ID |
0000-0003-3235-0454 |
|---|---|
| n.hopknson@ic.ac.uk |
Study information
| Study design | 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 the contact details below to request a patient information sheet |
| Scientific title | EDEN-EPIC: Effect of dietary nitrate supplementation on exercise performance in COPD - a randomised double-blind cross-over placebo controlled trial |
| Study acronym | EDEN-EPIC |
| 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. |
| Ethics approval(s) | London Bromley Research Ethics Committee, ref: 13/LO/0372 |
| Condition | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Current interventions as of 03/06/2015: 140 ml concentrated beetroot juice or matched nitrate-depleted placebo. Previous interventions: 70 ml concentrated beetroot juice or matched nitrate-depleted placebo. |
| Intervention type | Supplement |
| Primary outcome measure | Time to exhaustion in a fixed workload cycle ergometer test at 70% VO2max |
| Secondary outcome measures | 1. Area under VO2 curve to isotime (VO2) during endurance cycle ergometry 2. Fractional oxygen extraction of quadriceps muscle as assessed by NIRS |
| Overall study start date | 01/05/2013 |
| Overall study end date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25 |
| Participant inclusion criteria | Adult patients with a clinical and spirometric diagnosis of COPD, GOLD stage II-IV. |
| Participant exclusion criteria | Clinically unstable patients (within one month of exacerbation), significant comorbidity limiting exercise tolerance, significant renal impairment (estimated glomerular filtration rate (eGFR) <50 ml.min-1), hypotension (systolic blood pressure <100 mmHg), pregnancy, use of nitrate based medication, other reason for benefit from nitrate supplementation (ischaemic heart disease, peripheral arterial disease), use of long-term oxygen therapy. |
| Recruitment start date | 01/05/2013 |
| Recruitment end date | 31/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Chelsea
London
SW3 6NP
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Lucy Parker
Regulatory Compliance
Room 510, 5th floor Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom
| lucy.parker@imperial.ac.uk | |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/12/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
