Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise
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 Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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|
- O2 cost of moderate-intensity cycling exercise [ Time Frame: Twice over a maximum of a 2 month period ] [ Designated as safety issue: No ]whether nitrate reduces the O2 cost of moderate intensity exercise.
- 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) ] [ Designated as safety issue: No ]
- Functional capacity measured by 6-Minute Walking Test (6MWT) [ Time Frame: Twice over a maximum of a 2 month period ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Dietary Supplement: Beetroot
Other Name: James Whites Drinks beetroot sports shotDietary Supplement: Beetroot placebo
Other Name: James Whites Drinks beetroot sports shot
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712386
|Contact: Lee Dobson, MDfirstname.lastname@example.org|
|Contact: Anthony I Shepherd, MScemail@example.com|
|South Devon Healthcare NHS Foundation Trust||Recruiting|
|Torquay, Devon, United Kingdom, TQ2 7AA|
|Contact: Lee Dobson, MD 01803654014 firstname.lastname@example.org|
|Contact: Anthony I Shepherd, MSc 07852201881 email@example.com|
|Sub-Investigator: Mark Gilchrist, MD|
|Sub-Investigator: Anthony I Shepherd, MSc|
|Sub-Investigator: Daryl Wilkerson, PhD|
|Sub-Investigator: Andrew Jones, Professor|
|Sub-Investigator: Paul Winyard, Professor|
|Sub-Investigator: Angela Shore, Professor|
|Principal Investigator:||Nigel Benjamin, Professor||South Devon Healthcare NHS Foundation Trust|