Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate solution) and the placebo, separated by a 1 wk washout period. The investigators will test the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic efficiency in patients with COPD compared to the placebo.

Official Title
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The Effects of Dietary Nitrate Supplementation on Metabolic Efficiency in Patients With COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Dietary Supplement: Nitrate supplementation
* Dietary Supplement: Placebo supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD Indication metabolic inefficiency Exclusion Criteria: Sodium intake limitation Long-term oxygen therapy Severe renal impairment Use of medications that may interact with nitrate Contra-indications for performing (sub)maximal cycle ergometry

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitrate supplementation<br>Sodium nitrate solution | Dietary Supplement: Nitrate supplementation<br>* 7 days of supplementation with sodium nitrate solution<br>Dietary Supplement: Placebo supplementation<br>* 7 days of supplementation with sodium chloride solution<br>|
| Placebo Comparator: Placebo supplementation<br>Sodium chloride solution | Dietary Supplement: Nitrate supplementation<br>* 7 days of supplementation with sodium nitrate solution<br>Dietary Supplement: Placebo supplementation<br>* 7 days of supplementation with sodium chloride solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic efficiency during exercise | Metabolic efficiency (degree of efficiently used energy during exercise) will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks. | Baseline, day 7, day 14 and day 21. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure during exercise | Change in blood pressure will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks. | Baseline, day 7, day 14 and day 21. | 
| Change in dyspnea during exercise | Change in dyspnea will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks. | Baseline, day 7, day 14 and day 21. | 
| Change in cycle endurance time during exercise. | Change in cycle endurance time will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks. | Baseline, day 7, day 14 and day 21. | 
| Change in oxygen uptake (VO2 mL/min) during exercise | Change in oxygen uptake will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks. | Baseline, day 7, day 14 and day 21 | 
| Change in Resting Energy Expenditure (REE) | Change in REE will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks. | Baseline, day 7, day 14 and day 21 | 
| Change in plasma concentrations of nitrate and nitrite, glucose, insulin, lactate and free fatty acids, IFABP and cardiac troponin | Change in these plasma concentrations will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks. | Baseline, day 7, day 14 and day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, nitrate supplementation, metabolic efficiency