Condition category
Respiratory
Date applied
11/04/2013
Date assigned
22/04/2013
Last edited
04/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicholas Hopkinson

ORCID ID

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

Contact details

Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom
-
n.hopknson@ic.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1

Study information

Scientific title

EDEN-EPIC: Effect of dietary nitrate supplementation on exercise performance in COPD - a randomised double-blind cross-over placebo controlled trial

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

London Bromley Research Ethics Committee, ref: 13/LO/0372

Study design

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 the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Dietary nitrate supplementation (beetroot juice)

Primary outcome measures

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 trial start date

01/05/2013

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients with a clinical and spirometric diagnosis of COPD, GOLD stage II-IV.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

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

United Kingdom

Trial participating centre

Royal Brompton Hospital
Sydney Street Chelsea
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Imperial College London and Imperial College Healthcare NHS Trust (UK)

Sponsor details

c/o Lucy Parker
Regulatory Compliance
Room 510
5th floor Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
-
lucy.parker@imperial.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Brompton Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

01/06/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4689520/

Publication citations

Additional files

Editorial Notes