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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic obstructive pulmonary disease (COPD)

Condition category

Condition code

Respiratory

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]

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]

Improvement in endurance shuttle walk test performance.

Timepoint [1]

2nd and 3rd session of exercise testing, compared to baseline testing.

Secondary outcome [1]

Borg dyspnoea scores.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Monash Medical Centre

Address [1]

246 Clayton Road
Clayton VIC 3168

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Prof Phillip Bardin, Head of Respiratory & Sleep Medicine

Address [1]

Department of Respiratory & Sleep Medicine
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Southern Health HREC A

Ethics committee address [1]

Research Support Unit
Level 4 Main Block
Monash Medical Centre 
246 Clayton Road
Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/10/2011

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Adrian Chazan

Address

Department of General Medicine
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168

Country

Australia

Phone

+61395941311

Fax

adrianchazan@gmail.com

Contact person for scientific queries

Name

Dr Adrian Chazan

Address

Department of General Medicine
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168

Country

Australia

Phone

+61395941311

Fax

adrianchazan@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	A double blind randomized placebo control crossover trial on the effect of dietary nitrate supplementation on exercise tolerance in stable moderate chronic obstructive pulmonary disease.	2015	https://dx.doi.org/10.1186/s12890-015-0057-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically