Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712386
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : October 3, 2014
South Devon Healthcare NHS Foundation Trust
Information provided by (Responsible Party):
NIHR Exeter Clinical Research Facility

Brief Summary:

Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced exercise capacity. This is because their lungs are damaged and because of increased work of breathing. In some patients, exercise capacity is reduced to such a level that even simple activities of daily living, such as washing and dressing, may impose a challenge.

Recent findings in healthy young people suggest that increasing the amount of nitrate in our diet in the form of beetroot juice can improve the ability to exercise. Studies involving cycling have shown that less oxygen is needed to perform the same level of exercise after taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be converted in the body to nitric oxide (NO), a substance which increases blood flow and may affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is that such dietary nitrate supplementation appears to reduce the amount of oxygen needed to complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of this study to see if such effects could be seen in COPD patients. If this is indeed the case, then it may suggest that a period of dietary supplementation of a relatively cheap, widely available, and natural food product may improve the ability of patients to undergo everyday tasks and ultimately improve their quality of life.

To help investigators understand the effects of dietary nitrate supplementation on the ability to exercise in COPD patients, the investigators will recruit 15 people with mild to moderate disease. They will complete a series of undemanding exercise tests on three separate occasions. On one occasion they will have had a course of nitrate rich beetroot juice leading up to the tests, and on the other occasion they will have had a course of beetroot juice with the nitrate removed. The investigators will monitor blood pressure, levels of nitrate and nitrite in the blood, oxygen uptake and functional capacity during the tests which will allow us to assess any effects that may have occurred as a result of increased nitrate intake.

Condition or disease Intervention/treatment Phase
COPD Dietary Supplement: Beetroot Dietary Supplement: Beetroot placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: The Effects of Dietary Nitrate Supplementation on the Oxygen Cost of Moderate-Intensity Exercise and Functional Capacity in Mild-Moderate COPD Patients
Study Start Date : November 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: COPD Dietary Supplement: Beetroot
Other Name: James Whites Drinks beetroot sports shot
Dietary Supplement: Beetroot placebo
Other Name: James Whites Drinks beetroot sports shot

Primary Outcome Measures :
  1. O2 cost of moderate-intensity cycling exercise [ Time Frame: Twice over a maximum of a 2 month period ]
    whether nitrate reduces the O2 cost of moderate intensity exercise.

Secondary Outcome Measures :
  1. Single-breath lung diffusion capacity [ Time Frame: Once at screening. i.e. on one day that will last 10 seconds (before should only have been at familiarisation) ]

Other Outcome Measures:
  1. Functional capacity measured by 6-Minute Walking Test (6MWT) [ Time Frame: Twice over a maximum of a 2 month period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mild-moderate COPD (FEV1 30%-80% predicted values)
  • Between the ages of 40-75
  • Able to give informed consent

Exclusion Criteria:

  • Uncontrolled hypertension (systolic BP> 160mmHg, diastolic >100mmHg)
  • Regular therapy with organic nitrates, nicorandil and antibiotics.
  • Current smoker (Have smoked within the last 3 months)
  • Chronic Kidney Disease (stage 4 or worse)
  • Any other serious medical condition which would interfere with data interpretation and safety or that may make cycling exercise difficult, limited or uncomfortable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01712386

United Kingdom
South Devon Healthcare NHS Foundation Trust
Torquay, Devon, United Kingdom, TQ2 7AA
Sponsors and Collaborators
NIHR Exeter Clinical Research Facility
South Devon Healthcare NHS Foundation Trust
Principal Investigator: Nigel Benjamin, Professor South Devon Healthcare NHS Foundation Trust

Responsible Party: NIHR Exeter Clinical Research Facility Identifier: NCT01712386     History of Changes
Other Study ID Numbers: 12/SW/0327
PC/jse ( Other Grant/Funding Number: Torbay Medical Research Fund )
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases