Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Dietary Supplement: Nitrate supplementation; Dietary Supplement: Placebo supplementation

• Registration Number: NCT02084758
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-17
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-12
• Study Start: 2015-09
• Status Verified: 2016-09
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nitrate supplementation	Nitrate supplementation	Sodium nitrate solution
Placebo supplementation	Nitrate supplementation	Sodium chloride solution
Nitrate supplementation	Placebo supplementation	Sodium nitrate solution
Placebo supplementation	Placebo supplementation	Sodium chloride solution

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands