CClinicalTrials.gg
CompletedNCT02148289CHB-BRJ-COPDUpdated Jun 5, 2014

Dietary Nitrate in COPD

An interventional study of Nitrate rich beverage and Nitrate free beverage in Chronic Obstructive Pulmonary Disease, sponsored by Royal College of Surgeons, Ireland. Completed. Per ClinicalTrials.gov, last updated 2014-06-05.

Sponsored by Royal College of Surgeons, Ireland · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD, beetroot, dietary nitrate, nitric oxide
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 12 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Information consenting out-patients with a previous physician diagnosis of COPD
  • Clinically stable
  • Ambulatory

Exclusion criteria

Exclusion Criteria:

  • Subjects who required supplemental oxygen for exercise
  • Subjects with pulmonary hypertension and angina
  • Intolerant to beetroot
  • Insulin dependent diabetes
  • Thyroid disease
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Nitrate rich beverage

    Nitrate rich beverage will contain 140ml nitrate rich beetroot juice + 200ml blackcurrant juice containing 12.7mmol nitrate

    Dietary Supplement: Nitrate rich beverage

  • Placebo comparator
    Nitrate free beverage

    Nitrate free beverage will 140ml water + 200ml blackcurrant juice containing \<0.5mmol nitrate

    Dietary Supplement: Nitrate free beverage

Interventions

  • Dietary supplementNitrate rich beverage

    Following randomisation on day 1, subjects will consume either the nitrate or nitrate-free beverage and then the crossover beverage on day 8.

    Also known as: Nitrate rich beetroot juice

  • Dietary supplementNitrate free beverage

    Following randomisation on day 1, subjects will consume either the nitrate or nitrate-free beverage and then the crossover beverage on day 8.

    Also known as: Placebo beverage

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h

Other outcomes

  1. Resting blood pressure

    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.

    Time frame: day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02148289
Lead sponsor
Royal College of Surgeons, Ireland
Collaborators
University College Dublin
Responsible party
Sponsor
First posted
May 28, 2014
Start date
Nov 2012
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Jun 5, 2014

Study contacts

Conor P Kerley, BSc
study director · University College Dublin
Liam J Cormican, MD
principal investigator · Royal College of Surgeons in Ireland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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