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Completed

NCT Number: NCT02084758

Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrate supplementation

Dietary Supplement

7 days of supplementation with sodium nitrate solution

Placebo supplementation

Dietary Supplement

7 days of supplementation with sodium chloride solution

Primary outcomes

  1. Change in metabolic efficiency during exercise

    Time frame: 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 outcomes

  1. Change in blood pressure during exercise

    Time frame: 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.

  2. Change in dyspnea during exercise

    Time frame: 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.

  3. Change in cycle endurance time during exercise.

    Time frame: 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.

  4. Change in oxygen uptake (VO2 mL/min) during exercise

    Time frame: 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.

  5. Change in Resting Energy Expenditure (REE)

    Time frame: 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.

  6. Change in plasma concentrations of nitrate and nitrite, glucose, insulin, lactate and free fatty acids, IFABP and cardiac troponin

    Time frame: 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.

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

    Time frame: Baseline

    Fat free mass and fat mass determined by DEXA-scan

  4. Lung function

    Time frame: Baseline

  5. Physical activity

    Time frame: During the two supplementation periods

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effects of Dietary Nitrate Supplementation on Metabolic Efficiency in Patients With COPD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 12, 2014
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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