Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

• ClinicalTrials.gov Identifier: NCT02084758
• Recruitment Status: Completed
• First Posted: March 12, 2014
• Last Update Posted: February 6, 2017
• Sponsor: Maastricht University Medical Center
• Information provided by (Responsible Party): Maastricht University Medical Center

Tracking Information

• First Submitted Date: February 17, 2014
• First Posted Date: March 12, 2014
• Last Update Posted Date: February 6, 2017
• Study Start Date: September 2015
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 10, 2014)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 23, 2015)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: March 10, 2014)

• 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.
• 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.
• 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.

Current Other Pre-specified Outcome Measures (submitted: September 23, 2015)

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

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Obstructive Pulmonary Disease

Intervention

• Dietary Supplement: Nitrate supplementation
  7 days of supplementation with sodium nitrate solution
• Dietary Supplement: Placebo supplementation
  7 days of supplementation with sodium chloride solution

Study Arms

• Active Comparator: Nitrate supplementation
  Sodium nitrate solution
  Interventions:

  • Dietary Supplement: Nitrate supplementation
  • Dietary Supplement: Placebo supplementation
• Placebo Comparator: Placebo supplementation
  Sodium chloride solution
  Interventions:

  • Dietary Supplement: Nitrate supplementation
  • Dietary Supplement: Placebo supplementation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 10, 2014): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT02084758
• Other Study ID Numbers: ABR-47701
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Maastricht University Medical Center
• Study Sponsor: Maastricht University Medical Center
• Collaborators: Not Provided

Investigators

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

• PRS Account: Maastricht University Medical Center
• Verification Date: September 2016