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Trial record 35 of 533 for:    NITRATE ION

Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

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

Tracking Information
First Submitted Date  ICMJE February 17, 2014
First Posted Date  ICMJE March 12, 2014
Last Update Posted Date February 6, 2017
Study Start Date  ICMJE September 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT02084758 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02084758
Other Study ID Numbers  ICMJE ABR-47701
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Annemie Schols, Prof. Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP