Chronic Obstructive Pulmonary DiseaseCHB-BRJ-COPDNCT02148289
Dietary Nitrate in COPD
A study testing Nitrate rich beverage and Nitrate free beverage in people with Chronic Obstructive Pulmonary Disease, run by Royal College of Surgeons, Ireland.
Trial summary
The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption, in the form of beetroot juice, might increase… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Nitrate rich beverage and Nitrate free beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Information consenting out-patients with a previous physician diagnosis of COPD
- Clinically stable
- Ambulatory
Who cannot join
- Subjects who required supplemental oxygen for exercise
- Subjects with pulmonary hypertension and angina
- Intolerant to beetroot
- Insulin dependent diabetes
- Thyroid disease
About this study
Official title: Dietary Nitrate in COPD: A Double-blind, Randomized, Placebo-controlled, Crossover Trial
The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption, in the form of beetroot juice, might increase incremental shuttle walk test (ISWT) distance in COPD subjects.
Read the detailed description
Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in COPD subjects compared to a matched, low-nitrate drink.
This study is a randomized, double-blind placebo-controlled, crossover trial.
Resting blood pressure, phlebotomy and ISWT are performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Nitrate rich beverage, Nitrate free beverage
- Keywords
- COPD, beetroot, dietary nitrate, nitric oxide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate rich beverageDietary supplement
Also called Nitrate rich beetroot juice
Following randomisation on day 1, subjects will consume either the nitrate or nitrate-free beverage and then the crossover beverage on day 8.
Nitrate free beverageDietary supplement
Also called Placebo beverage
Following randomisation on day 1, subjects will consume either the nitrate or nitrate-free beverage and then the crossover beverage on day 8.
| Study group | Role | What they receive |
|---|---|---|
| Nitrate rich beverage | Active comparator | Nitrate rich beverage will contain 140ml nitrate rich beetroot juice + 200ml blackcurrant juice containing 12.7mmol nitrate Receives: Dietary Supplement: Nitrate rich beverage |
| Nitrate free beverage | Placebo comparator | Nitrate free beverage will 140ml water + 200ml blackcurrant juice containing <0.5mmol nitrate Receives: Dietary Supplement: Nitrate free beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Incremental Shuttle Walk Test Distance
The change between day 1, time 0 and day 1, time 3h will be compared to the changes between day 8, time 0 and day 8, time 3h.
Measured: day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin
- Responsible party
- Sponsor
- Investigators
- Conor P Kerley, BSc, Study director, University College DublinLiam J Cormican, MD, Principal investigator, Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148289
- Sponsor's protocol ID
- CHB-BRJ-COPD
- Acronym
- CHB-BRJ-COPD
- Status last verified
- Jun 2014
- First submitted
- 19 May 2014
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Nitrate in COPD: A Double-blind, Randomized, Placebo-controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT02148289
- Acronym / sponsor ID
- CHB-BRJ-COPD / CHB-BRJ-COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, beetroot, dietary nitrate, nitric oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- University College Dublin
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption, in the form of beetroot juice, might increase incremental shuttle walk test (ISWT) distance in COPD subjects.
Detailed description
Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in COPD subjects compared to a matched, low-nitrate drink.
This study is a randomized, double-blind placebo-controlled, crossover trial.
Resting blood pressure, phlebotomy and ISWT are performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate rich beverage | Active comparator | Dietary Supplement: Nitrate rich beverageNitrate rich beverage will contain 140ml nitrate rich beetroot juice + 200ml blackcurrant juice containing 12.7mmol nitrate |
| Nitrate free beverage | Placebo comparator | Dietary Supplement: Nitrate free beverageNitrate free beverage will 140ml water + 200ml blackcurrant juice containing <0.5mmol nitrate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Information consenting out-patients with a previous physician diagnosis of COPD
- Clinically stable
- Ambulatory
Key exclusion criteria (5 listed)
- Subjects who required supplemental oxygen for exercise
- Subjects with pulmonary hypertension and angina
- Intolerant to beetroot
- Insulin dependent diabetes
- Thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrate rich beverageAlso: Nitrate rich beetroot juiceFollowing randomisation on day 1, subjects will consume either the nitrate or nitrate-free beverage and then the crossover beverage on day 8. | Dietary supplement | Nitrate rich beverage |
| Nitrate free beverageAlso: Placebo beverageFollowing randomisation on day 1, subjects will consume either the nitrate or nitrate-free beverage and then the crossover beverage on day 8. | Dietary supplement | Nitrate free beverage |
Primary outcome
Change in Incremental Shuttle Walk Test Distance
Time frame: day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h
The change between day 1, time 0 and day 1, time 3h will be compared to the changes between day 8, time 0 and day 8, time 3h.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conor P Kerley, BSc study director
University College Dublin
Liam J Cormican, MD principal investigator
Royal College of Surgeons in Ireland
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate rich beverage and Nitrate free beverage in people with Chronic Obstructive Pulmonary Disease, run by Royal College of Surgeons, Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Incremental Shuttle Walk Test Distance (time frame: day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.