Chronic Obstructive Pulmonary DiseaseNCT02084758
Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Nitrate supplementation in people with Chronic Obstructive Pulmonary Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Nitrate supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD
- Indication metabolic inefficiency
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Nitrate supplementation, Placebo supplementation
- Keywords
- COPD, nitrate supplementation, metabolic efficiency
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate supplementationDietary supplement
7 days of supplementation with sodium nitrate solution
Placebo supplementationDietary supplement
7 days of supplementation with sodium chloride solution
| Study group | Role | What they receive |
|---|---|---|
| Nitrate supplementation | Active comparator | Sodium nitrate solution Receives: Dietary Supplement: Nitrate supplementation; Dietary Supplement: Placebo supplementation |
| Placebo supplementation | Placebo comparator | Sodium chloride solution Receives: Dietary Supplement: Nitrate supplementation; Dietary Supplement: Placebo supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, day 7, day 14 and day 21.
Secondary outcomes (6)
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.
Measured: Baseline, day 7, day 14 and day 21.
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.
Measured: Baseline, day 7, day 14 and day 21.
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.
Measured: Baseline, day 7, day 14 and day 21.
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.
Measured: Baseline, day 7, day 14 and day 21
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.
Measured: 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
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.
Measured: Baseline, day 7, day 14 and day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startSep 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemie Schols, Prof., Study director, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084758
- Sponsor's protocol ID
- ABR-47701
- Status last verified
- Sep 2016
- First submitted
- 17 Feb 2014
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Nitrate Supplementation on Metabolic Efficiency in Patients With COPD
- ClinicalTrials.gov ID
- NCT02084758
- Acronym / sponsor ID
- ABR-47701
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, nitrate supplementation, metabolic efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate supplementation | Active comparator | Dietary Supplement: Nitrate supplementation, Dietary Supplement: Placebo supplementationSodium nitrate solution |
| Placebo supplementation | Placebo comparator | Dietary Supplement: Nitrate supplementation, Dietary Supplement: Placebo supplementationSodium chloride solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD
- Indication metabolic inefficiency
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrate supplementation7 days of supplementation with sodium nitrate solution | Dietary supplement | Nitrate supplementation, Placebo supplementation |
| Placebo supplementation7 days of supplementation with sodium chloride solution | Dietary supplement | Nitrate supplementation, Placebo supplementation |
Primary outcome
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.
6 secondary outcomes
Change in blood pressure during exercise
Time frame: 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 cycle endurance time during exercise.
Time frame: 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 Resting Energy Expenditure (REE)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemie Schols, Prof. study director
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate supplementation in people with Chronic Obstructive Pulmonary Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in metabolic efficiency during exercise (time frame: Baseline, day 7, day 14 and day 21.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.