Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, nitrate supplementation, metabolic efficiency
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNitrate supplementation
7 days of supplementation with sodium nitrate solution
DIETARY_SUPPLEMENTPlacebo supplementation
7 days of supplementation with sodium chloride solution
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in metabolic efficiency during exercise | Baseline, day 7, day 14 and day 21. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma concentrations of nitrate and nitrite, glucose, insulin, lactate and free fatty acids, IFABP and cardiac troponin | Baseline, day 7, day 14 and day 21 | 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. |
| Change in blood pressure during exercise | Baseline, day 7, day 14 and day 21. | 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. |
| Change in dyspnea during exercise | Baseline, day 7, day 14 and day 21. | 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. |
| Change in cycle endurance time during exercise. | Baseline, day 7, day 14 and day 21. | 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. |
| Change in oxygen uptake (VO2 mL/min) during exercise | Baseline, day 7, day 14 and day 21 | 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. |
| Change in Resting Energy Expenditure (REE) | Baseline, day 7, day 14 and day 21 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| height, body weight and body mass index (BMI) | Baseline | — |
| Fat free mass and fat mass | Baseline | Fat free mass and fat mass determined by DEXA-scan |
| Lung function | Baseline | — |
| Physical activity | During the two supplementation periods | — |
| VO2max and Wmax | Baseline | — |
Countries
Netherlands
Outcome results
None listed