Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

N/ACompletedNCT02084758

Maastricht University Medical Center20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Nitrate supplementationDIETARY_SUPPLEMENT

7 days of supplementation with sodium nitrate solution

Placebo supplementationDIETARY_SUPPLEMENT

7 days of supplementation with sodium chloride solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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