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OpenTrials
Completed

NCT Number: NCT02148289

Dietary Nitrate in COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Nitrate rich beverage

Dietary Supplement

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

Other names: Nitrate rich beetroot juice

Nitrate free beverage

Dietary Supplement

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

Other names: Placebo beverage

Primary outcomes

  1. 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.

Other outcomes

  1. Resting blood pressure

    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.

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Collaborators

  • University College Dublin

Registry information

Official study title

Dietary Nitrate in COPD: A Double-blind, Randomized, Placebo-controlled, Crossover Trial

Acronym: CHB-BRJ-COPD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 28, 2014
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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