Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001088932
Ethics application status
Not yet submitted
Date submitted
14/09/2011
Date registered
20/10/2011
Date last updated
20/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary Nitrate Supplementation in Stable Chronic Obstructive Pulmonary Disease (COPD): A Randomised Controlled Trial
Scientific title
Amongst subjects with stable mild-moderate COPD, is dietary nitrate supplementation with beetroot juice safe and effective compared with placebo for improving submaximal exercise performance?
Secondary ID [1] 263007 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 270737 0
Condition category
Condition code
Respiratory 270914 270914 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be 3 phases to the study. Phase 1 is designed to assess safety. 10 of the subjects are randomly selected to take part in this phase. Subjects ingest a small dose of beetroot juice, and blood pressure and heart rate are observed over several hours. Phases 2 and 3 are designed to assess changes in exercise performance. All subjects take part in these phases. Baseline exercise tests are performed during the first session of testing. These comprise 2 incremental shuttle walk tests followed by an endurance shuttle walk test (ESWT). The following data is collected: distance walked, heart rate, blood pressure, oxygen saturation, symptom scores (Borg scale), all according to standardised procedures. There is then a 3-day wash-in period during which subjects drink beetroot juice or placebo twice daily. On day 4 the subjects attend for the 2nd testing session during which they perform a repeat ESWT four hours after the morning treatment dose with the same data collected. This is followed by a 4-day washout period. Phase 3 involves the crossing-over of subjects from each treatment group to the alternative treatment and repeating the testing as per phase 2. The data is then analysed to determine the magnitude of any decrease in blood pressure, improvement in exercise performance and change in symptom scores.

The beetroot juice product we will use is know as "Beet It", produced by James White Drinks Ltd (UK), which contains concentrated beetroot juice as well as small amount of lemon juice. It is packaged in 70mL plastic bottles.
Intervention code [1] 269356 0
Treatment: Other
Comparator / control treatment
The placebo treatment will be either a nitrate-depleted beetroot juice (the same "Beet It" product which has been depleted of nitrate) OR an apple and blackcurrant juice (Toddler Pops, produced by Schweppes), depending on availability, administered according to the same protocol as the intervention group.
Control group
Placebo

Outcomes
Primary outcome [1] 279624 0
Improvement in endurance shuttle walk test performance.
Timepoint [1] 279624 0
2nd and 3rd session of exercise testing, compared to baseline testing.
Secondary outcome [1] 294071 0
Borg dyspnoea scores.
Timepoint [1] 294071 0
2nd and 3rd session of exercise testing, compared to baseline testing.

Eligibility
Key inclusion criteria
Patients with stable mild-moderate chronic obstructive pulmonary disease (FEV1 > 50% predicted).
Physically able to perform a six-minute walk test.
Minimum age
45 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute exacerbation of COPD in the preceding month.
Long-term oxygen therapy.
Treatment with oral corticosteroids at the time of recruitment.
Treatment with beta-blockers.
A known diagnosis of ischaemic heart disease or heart failure.
Musculoskeletal disorders limiting exercise.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are recruited from outpatient clinics at Monash Medical Centre as well as with the use of a clinical trials database. The subjects are phoned by the principal investigator and if interested, written information is provided. After providing informed consent, subjects are randomly assigned to receive initially either the active treatment OR placebo. Each subject is given a unique study number. Sealed envelopes labelled with the study numbers contain the order of administration of the active treatment and placebo. The assignment is concealed from the investigators until the time of data analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator provides a study number for each subject, corresponding to an envelope containing group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269849 0
Hospital
Name [1] 269849 0
Monash Medical Centre
Country [1] 269849 0
Australia
Primary sponsor type
Individual
Name
Prof Don Campbell, Head of General Medicine
Address
Department of General Medicine
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 268875 0
None
Name [1] 268875 0
Address [1] 268875 0
Country [1] 268875 0
Other collaborator category [1] 252304 0
Individual
Name [1] 252304 0
Prof Phillip Bardin, Head of Respiratory & Sleep Medicine
Address [1] 252304 0
Department of Respiratory & Sleep Medicine
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country [1] 252304 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271824 0
Southern Health HREC A
Ethics committee address [1] 271824 0
Research Support Unit
Level 4 Main Block
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 271824 0
Australia
Date submitted for ethics approval [1] 271824 0
19/10/2011
Approval date [1] 271824 0
Ethics approval number [1] 271824 0

Summary
Brief summary
Dietary nitrate is known to protect against adverse cardiovascular events by reducing blood pressure and via effects on the vascular endothelium. Several studies have also shown that dietary nitrate supplementation (in the form in beetroot juice) leads to improvements in exercise performance in healthy subjects and elite athletes. No such investigation has been undertaken in patients with chronic obstructive pulmonary disease. Improving exercise tolerance and performance in this group of patients may significantly enhance the benefits derived from pulmonary rehabilitation in a sustainable fashion.
The aims of this project are to establish whether beetroot juice supplementation is safe and effective in improving exercise performance in patients with stable chronic obstructive pulmonary disease (COPD) who attend an outpatient exercise program. It is a randomised placebo-controlled double-blinded crossover trial.
Subjects with stable mild-moderate COPD are recruited and randomised to receive beetroot juice, BJ (in a commercially available form) or placebo, PL (an alternative juice). The placebo will either be beetroot juice which has been nitrate-depleted or apple & blackcurrent juice (depending on availability). There will be 3 phases to the study.
Phase 1 is designed to assess safety. 10 of the subjects are randomly selected to take part in this phase. Subjects ingest a small dose of beetroot juice, and blood pressure and heart rate are observed over several hours.
Phases 2 and 3 are designed to assess changes in exercise performance. All subjects take part in these phases. Baseline exercise tests are performed during the first session of testing. These comprise 2 incremental shuttle walk tests followed by an endurance shuttle walk test (ESWT). The following data is collected: distance walked, heart rate, blood pressure, oxygen saturation, symptom scores (Borg scale), all according to standardised procedures. There is then a 3-day wash-in period during which subjects drink beetroot juice or placebo twice daily. On day 4 the subjects attend for the 2nd testing session during which they perform a repeat ESWT four hours after the morning treatment dose with the same data collected. This is followed by a 4-day washout period.
Phase 3 involves the crossing-over of subjects from each treatment group to the alternative treatment and repeating the testing as per phase 2.
The data is then analysed to determine the magnitude of any decrease in blood pressure, improvement in exercise performance and change in symptom scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33133 0
Address 33133 0
Country 33133 0
Phone 33133 0
Fax 33133 0
Email 33133 0
Contact person for public queries
Name 16380 0
Dr Adrian Chazan
Address 16380 0
Department of General Medicine
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 16380 0
Australia
Phone 16380 0
+61395941311
Fax 16380 0
Email 16380 0
[email protected]
Contact person for scientific queries
Name 7308 0
Dr Adrian Chazan
Address 7308 0
Department of General Medicine
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 7308 0
Australia
Phone 7308 0
+61395941311
Fax 7308 0
Email 7308 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA double blind randomized placebo control crossover trial on the effect of dietary nitrate supplementation on exercise tolerance in stable moderate chronic obstructive pulmonary disease.2015https://dx.doi.org/10.1186/s12890-015-0057-4
N.B. These documents automatically identified may not have been verified by the study sponsor.