Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise

NCT01712386 | Completed

• 2 other identifiers: 12/SW/0327PC/jse
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• O2 cost of moderate-intensity cycling exercise

  whether nitrate reduces the O2 cost of moderate intensity exercise.

  Twice over a maximum of a 2 month period

Secondary Outcomes (1)

• Single-breath lung diffusion capacity

  Once at screening. i.e. on one day that will last 10 seconds (before should only have been at familiarisation)

Other Outcomes (1)

• Functional capacity measured by 6-Minute Walking Test (6MWT)

  Twice over a maximum of a 2 month period

Study Arms (1)

COPD

EXPERIMENTAL

Dietary Supplement: Beetroot; Dietary Supplement: Beetroot placebo

Interventions

Beetroot DIETARY_SUPPLEMENT

Also known as: James Whites Drinks beetroot sports shot

COPD

Beetroot placebo DIETARY_SUPPLEMENT

Also known as: James Whites Drinks beetroot sports shot

COPD

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NIHR Exeter Clinical Research Facility: lead
• Torbay and South Devon NHS Foundation Trust: collaborator

Study Sites (1)

South Devon Healthcare NHS Foundation Trust

Torquay, Devon, TQ2 7AA, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Nigel Benjamin, Professor

  Torbay and South Devon NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 23, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

GB (1)