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CompletedNCT02084758Updated Feb 6, 2017

Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • nitrate supplementation
  • metabolic efficiency
03

In context

Lung Diseases

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.

Browse Lung Diseases studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • COPD
  • Indication metabolic inefficiency

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Nitrate supplementation

    Sodium nitrate solution

    Dietary Supplement: Nitrate supplementation · Dietary Supplement: Placebo supplementation

  • Placebo comparator
    Placebo supplementation

    Sodium chloride solution

    Dietary Supplement: Nitrate supplementation · Dietary Supplement: Placebo supplementation

Interventions

  • Dietary supplementNitrate supplementation

    7 days of supplementation with sodium nitrate solution

  • Dietary supplementPlacebo supplementation

    7 days of supplementation with sodium chloride solution

06

What researchers measure

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

Other outcomes

  1. VO2max and Wmax

    Time frame: Baseline

  2. height, body weight and body mass index (BMI)

    Time frame: Baseline

  3. Fat free mass and fat mass

    Fat free mass and fat mass determined by DEXA-scan

    Time frame: Baseline

  4. Lung function

    Time frame: Baseline

  5. Physical activity

    Time frame: During the two supplementation periods

07

Study locations

1 site
  • Maastricht University Medical Center
    Maastricht, Limburg, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02084758
Lead sponsor
Maastricht University Medical Center
Responsible party
Sponsor
First posted
Mar 12, 2014
Start date
Sep 2015
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Feb 6, 2017

Study contacts

Annemie Schols, Prof.
study director · Maastricht University Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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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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