An interventional study of Nitrate supplementation and Placebo supplementation in Chronic Obstructive Pulmonary Disease, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-06.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion Criteria:
Sodium nitrate solution
Dietary Supplement: Nitrate supplementation · Dietary Supplement: Placebo supplementation
Sodium chloride solution
Dietary Supplement: Nitrate supplementation · Dietary Supplement: Placebo supplementation
7 days of supplementation with sodium nitrate solution
7 days of supplementation with sodium chloride solution
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.
Time frame: Baseline, day 7, day 14 and day 21.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, day 7, day 14 and day 21
VO2max and Wmax
Time frame: Baseline
height, body weight and body mass index (BMI)
Time frame: Baseline
Fat free mass and fat mass
Fat free mass and fat mass determined by DEXA-scan
Time frame: Baseline
Lung function
Time frame: Baseline
Physical activity
Time frame: During the two supplementation periods
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center