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Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Nitrate supplementation
Placebo supplementation
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, nitrate supplementation, metabolic efficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nitrate supplementation

Placebo supplementation

Arm Description

Sodium nitrate solution

Sodium chloride solution

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 17, 2014
Last Updated
February 3, 2017
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02084758
Brief Title
Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
The Effects of Dietary Nitrate Supplementation on Metabolic Efficiency in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, nitrate supplementation, metabolic efficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitrate supplementation
Arm Type
Active Comparator
Arm Description
Sodium nitrate solution
Arm Title
Placebo supplementation
Arm Type
Placebo Comparator
Arm Description
Sodium chloride solution
Intervention Type
Dietary Supplement
Intervention Name(s)
Nitrate supplementation
Intervention Description
7 days of supplementation with sodium nitrate solution
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplementation
Intervention Description
7 days of supplementation with sodium chloride solution
Primary Outcome Measure Information:
Title
Change in metabolic efficiency during exercise
Description
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 Outcome Measure Information:
Title
Change in blood pressure during exercise
Description
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.
Title
Change in dyspnea during exercise
Description
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.
Title
Change in cycle endurance time during exercise.
Description
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.
Title
Change in oxygen uptake (VO2 mL/min) during exercise
Description
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
Title
Change in Resting Energy Expenditure (REE)
Description
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
Title
Change in plasma concentrations of nitrate and nitrite, glucose, insulin, lactate and free fatty acids, IFABP and cardiac troponin
Description
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 Pre-specified Outcome Measures:
Title
VO2max and Wmax
Time Frame
Baseline
Title
height, body weight and body mass index (BMI)
Time Frame
Baseline
Title
Fat free mass and fat mass
Description
Fat free mass and fat mass determined by DEXA-scan
Time Frame
Baseline
Title
Lung function
Time Frame
Baseline
Title
Physical activity
Time Frame
During the two supplementation periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Schols, Prof.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
Country
Netherlands

12. IPD Sharing Statement

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Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

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