Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise

The Effects of Dietary Nitrate Supplementation on the Oxygen Cost of Moderate-Intensity Exercise and Functional Capacity in Mild-Moderate COPD Patients

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Dietary supplement: Beetroot; Dietary supplement: Beetroot placebo

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Torquay, Devon, United Kingdom, TQ2 7AA
      • South Devon Healthcare NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD	Dietary supplement: Beetroot; Other Names: James Whites Drinks beetroot sports shot; Dietary supplement: Beetroot placebo; Other Names: James Whites Drinks beetroot sports shot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Functional capacity measured by 6-Minute Walking Test (6MWT)	Twice over a maximum of a 2 month period

Collaborators and Investigators

• Sponsor: NIHR Exeter Clinical Research Facility
• Collaborators: Torbay and South Devon NHS Foundation Trust
• Investigators: Principal Investigator: Nigel Benjamin, Professor, Torbay and South Devon NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 19, 2012
• First Posted (Estimate): October 23, 2012

Study Record Updates

• Last Update Posted (Estimate): October 3, 2014
• Last Update Submitted That Met QC Criteria: October 2, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 12/SW/0327; PC/jse (Other Grant/Funding Number: Torbay Medical Research Fund)