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Trial record 35 of 534 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

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Dietary Supplement: Nitrate supplementation Dietary Supplement: Placebo supplementation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Dietary Nitrate Supplementation on Metabolic Efficiency in Patients With COPD
Study Start Date : September 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084758


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Study Director: Annemie Schols, Prof. Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02084758     History of Changes
Other Study ID Numbers: ABR-47701
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: September 2016
Keywords provided by Maastricht University Medical Center:
COPD
nitrate supplementation
metabolic efficiency
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pharmaceutical Solutions