Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by NIHR Exeter Clinical Research Facility
Sponsor:
Collaborator:
South Devon Healthcare NHS Foundation Trust
Information provided by (Responsible Party):
NIHR Exeter Clinical Research Facility
ClinicalTrials.gov Identifier:
NCT01712386
First received: October 12, 2012
Last updated: June 12, 2013
Last verified: October 2012
  Purpose

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 Intervention
COPD
Dietary Supplement: Beetroot
Dietary Supplement: Beetroot placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by NIHR Exeter Clinical Research Facility:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712386

Contacts
Contact: Lee Dobson, MD 01803654014 lee.dobson@nhs.net
Contact: Anthony I Shepherd, MSc 07852201881 ais204@exeter.ac.uk

Locations
United Kingdom
South Devon Healthcare NHS Foundation Trust Recruiting
Torquay, Devon, United Kingdom, TQ2 7AA
Contact: Lee Dobson, MD    01803654014    lee.dobson@nhs.net   
Contact: Anthony I Shepherd, MSc    07852201881    ais204@exeter.ac.uk   
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         
Sponsors and Collaborators
NIHR Exeter Clinical Research Facility
South Devon Healthcare NHS Foundation Trust
Investigators
Principal Investigator: Nigel Benjamin, Professor South Devon Healthcare NHS Foundation Trust
  More Information

No publications provided

Responsible Party: NIHR Exeter Clinical Research Facility
ClinicalTrials.gov Identifier: NCT01712386     History of Changes
Other Study ID Numbers: 12/SW/0327, PC/jse
Study First Received: October 12, 2012
Last Updated: June 12, 2013
Health Authority: United Kingdom: Department of Health

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

ClinicalTrials.gov processed this record on July 28, 2014