Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

February 3, 2017 updated by: Maastricht University Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitrate supplementation
Sodium nitrate solution
Dietary supplement: Nitrate supplementation
7 days of supplementation with sodium nitrate solution
Dietary supplement: Placebo supplementation
7 days of supplementation with sodium chloride solution
Placebo Comparator: Placebo supplementation
Sodium chloride solution
Dietary supplement: Nitrate supplementation
7 days of supplementation with sodium nitrate solution
Dietary supplement: Placebo supplementation
7 days of supplementation with sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, day 7, day 14 and day 21.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, day 7, day 14 and day 21.
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.
Baseline, day 7, day 14 and day 21.
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.
Baseline, day 7, day 14 and day 21.
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.
Baseline, day 7, day 14 and day 21
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.
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
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.
Baseline, day 7, day 14 and day 21

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2max and Wmax
Time Frame: Baseline
Baseline
height, body weight and body mass index (BMI)
Time Frame: Baseline
Baseline
Fat free mass and fat mass
Time Frame: Baseline
Fat free mass and fat mass determined by DEXA-scan
Baseline
Lung function
Time Frame: Baseline
Baseline
Physical activity
Time Frame: During the two supplementation periods
During the two supplementation periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Study Director: Annemie Schols, Prof., Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABR-47701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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