The effects of dietary nitrate supplementation on metabolic efficiency in patients with COPD
- Conditions
- Chronic Obstructive Pulmonary Disease10006436
- Registration Number
- NL-OMON44154
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1) COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
2) Peak VO2 / peak load > 10 ml/min/W, as a indication for metabolic inefficiency, determined using CPET data available from the assessment.
- Sodium intake limitation
- Long-term oxygen therapy, because of the methodology that is used to measure oxygen uptake and ventilation
- Severe renal impairment (GFR < 30 ml/min), because nitrate is excreted mainly by the kidneys and thus depends on the patient*s renal function.
- Use of medications that might develop a risk for hypotension in combination with nitrate: PDE-5 inhibitors (sildenafil, tadaladil, verdanefil), nitrate-containing/releasing medication (glyceryl trinitrate, isosorbide dinitrate, isosorbide mononitrate, nitroprusside). The medical doctor will screen the prescibed medications during the baseline assessment, but the investigator will verify which medication are used by the patient in question during the recruitment and just before start with the intervention;
- Contra-indications for performing (sub)maximal cycle ergometry during the baseline assessment preceding the rehabilitation program.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary parameter is metabolic efficiency during submaximal cycle ergometry<br /><br>tests (before and after 7 days of ingestion of both NaNO3 solution and NaCl<br /><br>placebo).<br /><br><br /><br>Metabolic efficiency will be calculated with the following equation:<br /><br><br /><br>Metabolic efficiency = (load (W) of exercise * 0.01433 (kcal*min-1) / (energy<br /><br>expenditure during exercise * REE)(kcal*min-1)*100%</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are bloodpressure, dyspnea, cycle endurance time, Oxygen<br /><br>uptake during rest and exercise, body temperature, blood markers (e.g. lactate,<br /><br>IFABP as a marker for intestinal damage and cardiac troponin as a marker for<br /><br>myocardial injury) . These parameters will be measured at 4 times (before and<br /><br>after 7 days of ingestion of both NaNO3 solution and NaCl placebo). </p><br>