Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise

NCT ID: NCT01712386

Last Updated: 2014-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-01-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

COPD

Group Type: EXPERIMENTAL

Beetroot

Intervention Type: DIETARY_SUPPLEMENT

Beetroot placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Beetroot

Intervention Type: DIETARY_SUPPLEMENT

Beetroot placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

James Whites Drinks beetroot sports shot; James Whites Drinks beetroot sports shot

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Torbay and South Devon NHS Foundation Trust

OTHER

Sponsor Role: collaborator

NIHR Exeter Clinical Research Facility

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nigel Benjamin, Professor

Role: PRINCIPAL_INVESTIGATOR

Torbay and South Devon NHS Foundation Trust

Locations

South Devon Healthcare NHS Foundation Trust

Torquay, Devon, United Kingdom

Countries

United Kingdom

Other Identifiers

PC/jse

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12/SW/0327

Identifier Type: -

Identifier Source: org_study_id