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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Dietary Supplement: Dietary nitrate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrate rich beetroot juice<br>Concentrated, beetroot juice is a rich source of dietary nitrate. | Dietary Supplement: Dietary nitrate<br>* 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.<br>* Other names: Beetroot juice;|
| Placebo Comparator: Nitrate depleted placebo beetroot juice<br>Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content. | Dietary Supplement: Placebo<br>* 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.<br>* Other names: Nitrate depleted beetroot juice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in incremental shuttle walk test distance |  | Day 1, day 15 and day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma nitrate | Assessed by chemiluminescence | Day 1, day 15 and day 29 | 
| Change in ambulatory blood pressure |  | Day 1, day 15 and day 29 | 
| Change in quality of life | Quality of Life will be assessed with the Clinical COPD Questionnaire | Day 1, day 15 and day 29 | 
| Change in forced expiratory volume | Assessed by spirometry | Day 1, day 15 and day 29 | 
| Change in inflammatory markers | Assessed by C-reactive protein | Day 1, day 15 and day 29 | 
| Change in forced vital capacity | Assessed by spirometry | Day 1, day 15 and day 29 | 
| Change in plasma nitrate and nitrite | Assessed by chemiluminescence | Day 1, day 15 and day 29 |