A 2 Week, Crossover Trial of Dietary Nitrate in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Dietary Nitrate for COPD: a 14d, Randomized, Placebo-controlled, Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521532
• Other study ID #: Chronic NO3- in COPD
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: October 22, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: August 2015
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in obstructive sleep apnea syndrome (OSAS) has not been reported.

Description:

Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in OSAS has not been reported.

The investigators hypothesize that chronic nitrate consumption might increase exercise tolerance, and exhaled NO but decrease blood pressure and have little impact on quality of life and pulmonary function.

This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint exercise tolerance, pulmonary function, quality of life and ambulatory blood pressure will be assessed in conjunction with demographics and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Clinically stable,

• Diagnosed with COPD

• Ambulatory out-patients

Exclusion Criteria:

• Long term oxygen therapy

• Pulmonary hypertension

• Active cardiovascular disease

• Active skeletal conditions

• Taking vasodilators

• Diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• Dietary nitrate
140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
• Placebo
140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.

Locations

Country	Name	City	State
Ireland	Respiratory & Sleep Diagnostics Department, Connolly Hospital	Dublin

Sponsors (3)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	Connolly Hospital Blanchardstown, University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in incremental shuttle walk test distance		Day 1, day 15 and day 29	No
Secondary	Change in plasma nitrate	Assessed by chemiluminescence	Day 1, day 15 and day 29	No
Secondary	Change in ambulatory blood pressure		Day 1, day 15 and day 29	Yes
Secondary	Change in quality of life	Quality of Life will be assessed with the Clinical COPD Questionnaire	Day 1, day 15 and day 29	No
Secondary	Change in forced expiratory volume	Assessed by spirometry	Day 1, day 15 and day 29	Yes
Secondary	Change in inflammatory markers	Assessed by C-reactive protein	Day 1, day 15 and day 29	Yes
Secondary	Change in forced vital capacity	Assessed by spirometry	Day 1, day 15 and day 29	No
Secondary	Change in plasma nitrate and nitrite	Assessed by chemiluminescence	Day 1, day 15 and day 29	No