Interstitial Lung DiseaseNCT04299945
Effects of Drinking Beetroot Juice on Exercise Performance in Patients With Fibrotic Interstitial Lung Disease
A study testing concentrated beetroot juice (400mg of nitrate per serving) and concentrated beetroot juice (trace amounts of nitrate per serving) in people with Interstitial Lung Disease, run by University of British Columbia at 2 sites in Canada.
Trial summary
Exercise training as part of a structured pulmonary rehabilitation program is a key factor in improving quality of life and symptoms in people with interstitial lung disease (ILD). Optimal methods of exercise training are yet to be explored in ILD. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- concentrated beetroot juice (400mg of nitrate per serving) and concentrated beetroot juice (trace amounts of nitrate per serving)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesCanada
- Study dates
- 7 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses
- Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
- Oxygen saturation ≥92% by pulse oximetry at rest while breathing room air
- Clinically stable for the preceding 6 weeks
- Can fluently read and write in English
Who cannot join
- Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease) (see Table 4 from ERS/ATS consensus statement)
- Other significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
- FVC <50% or DLCO <25%
- Use of prednisone >10 mg/day for >2 weeks within 3 months of the first study visit
- Cardiac pacemaker or any metal or electronics inside of the body
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Providence Health Care - St. Paul's Hosptial
Vancouver, British Columbia, V6Z 1Y6
Jordan Guenette, Ph.D, 604-682-2344, jordan.guenette@hli.ubc.ca
- Recruiting
Vancouver Coastal Health
Vancouver, V5Z 1M9
About this study
Official title: The Effects of Dietary Nitrate Supplementation on Exercise Tolerance in Patients With Fibrotic Interstitial Lung Disease
Exercise training as part of a structured pulmonary rehabilitation program is a key factor in improving quality of life and symptoms in people with interstitial lung disease (ILD). Optimal methods of exercise training are yet to be explored in ILD. Drinking beetroot juice, which is rich in nitrate, has been shown to improve exercise performance in a variety of groups, but its effects in ILD have not been tested. The purpose of this study is to determine if drinking nitrate-rich beetroot juice can improve exercise performance compared to drinking nitrate-free beetroot juice in people with ILD.
Read the detailed description
PURPOSE:
The primary purpose of this study is to determine the effects of dietary nitrate supplementation on submaximal cycle exercise performance in patients with fibrotic ILD.
HYPOTHESIS:
Our primary hypothesis is that dietary nitrate supplementation will result in greater improvement in submaximal cycle exercise endurance time compared with placebo.
JUSTIFICATION:
Fibrotic interstitial lung disease (ILD) is a heterogeneous group of disorders that cause scarring/fibrosis or inflammation of the lungs, resulting in significant morbidity and high mortality. Almost all ILDs are characterized by dyspnoea and functional limitation and there are few effective and/or well-tolerated pharmacotherapies for many ILD subtypes.
Exertional dyspnoea leads to reduced exercise capacity in ILD, and this functional limitation is further worsened by skeletal muscle weakness and dysfunction. Both dyspnoea and poor exercise tolerance are strongly associated with quality of life and mortality in ILD and thus improving dyspnoea and functional capacity are important goals in the management of ILD.
Pulmonary rehabilitation is a structured evidence-based exercise and education intervention that is recommended for most patients with ILD. Pulmonary rehabilitation improves dyspnoea, functional capacity, and quality of life in patients with ILD; however, these benefits are often modest and only temporary. The exercise component of pulmonary rehabilitation is the predominant mediator of benefit; however, there are no studies that have investigated the optimal method of exercise training in patients with ILD. Thus, there is a clear need to identify new strategies that can provide larger and more persistent benefits from pulmonary rehabilitation.
Nitric oxide (NO) is a physiological signaling molecule that plays a critical role in vascular control. There is accumulating evidence that dietary nitrate, consumed in the form of beetroot juice, can increase the bioavailability of NO and subsequently enhance exercise performance in healthy, elite athlete, as well as diseased populations. These improvements may be related, but not limited to, enhanced efficiency of locomotion, peripheral locomotor oxygen delivery, and/or muscle power. The specific effects of dietary nitrate supplementation in ILD patients has yet to be explored. However, there is great potential for the use of this dietary supplement to improve exercise tolerance during, and improve patient outcomes from, pulmonary rehabilitation.
STATISTICAL ANALYSIS:
A p value <0.05 will be considered significant for all analyses. Data analysis will be performed using Microsoft Excel 2013 (Microsoft Corporation, Redmond, Washington, US) and Stata v12 (StataCorp, Texas, US).
Primary outcome: The primary outcome of cycle endurance time will be based on the duration patients were able to exercise during the constant work rate exercise test. A t-test will be used to compare endurance times between the intervention and placebo conditions.
The investigators have chosen to power this study based on the primary outcome of change in cycle exercise endurance time. Based on previously collected data in our laboratory in patients with ILD that show a standard deviation of 289.96 seconds for a 75% constant work rate cycle exercise test with a conservative between test correlation of 0.90, the investigators calculated that 15 participants would be needed to detect the minimal clinically important difference of 105 seconds between conditions assuming a two-sided α of 0.05 and 80% power.
- Conditions
- Interstitial Lung Disease
- Being tested
- concentrated beetroot juice (400mg of nitrate per serving), concentrated beetroot juice (trace amounts of nitrate per serving)
- Keywords
- ILD, Nitrates, exercise, interstitial lung disease
- Medical subject headings
- Lung Diseases, Interstitial, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentrated beetroot juice (400mg of nitrate per serving)Dietary supplement
Dietary nitrate supplementation includes consumption of two beverages daily for 7 consecutive days.
concentrated beetroot juice (trace amounts of nitrate per serving)Dietary supplement
Dietary placebo supplementation includes consumption of two beverages daily for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Dietary nitrate supplementation | Experimental | The dietary nitrate supplement will be a concentrated, nitrate-rich beetroot juice (70 ml providing ∼400mg nitrate per serving) Receives: Dietary Supplement: concentrated beetroot juice (400mg of nitrate per serving) |
| Placebo | Placebo comparator | The placebo will be a concentrated, nitrate-depleted beetroot juice (70 ml with trace amounts of nitrate) Receives: Dietary Supplement: concentrated beetroot juice (trace amounts of nitrate per serving) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in submaximal cycle exercise endurance time following dietary nitrate supplementation compared to placebo supplementation.
Exercise endurance time will be measured during submaximal constant load cycle exercise testing.
Measured: 1 Week
Secondary outcomes (7)
Difference in exertional dyspnoea during submaximal cycle exercise following dietary nitrate supplementation compared to placebo supplementation.
Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed at rest and every 1 minute during submaximal constant load cycle exercise testing until exhaustion.
Measured: 1 Week
Difference in exertional dyspnoea during activities of daily living following dietary nitrate supplementation compared to placebo supplementation.
Shortness of breath during daily living patterns will be assessed using established questionnaires.
Measured: 1 Week
Difference in concentration of plasma nitrate ([NO3-]) and nitrite ([NO2-]) following dietary nitrate supplementation compared to placebo supplementation.
Blood samples will be taken and analyzed for the concentration levels of nitrates in blood plasma.
Measured: 1 Week
Difference in resting, exercise, and post-exercise blood pressure following dietary nitrate supplementation compared to placebo supplementation.
Blood pressure will be measured using a manual sphygmomanometer at rest, every 2 minutes during submaximal constant load cycle exercise testing until exhaustion, and 5 minutes after exercise ends.
Measured: 1 Week
Difference in oxygen cost of submaximal cycle exercise following dietary nitrate supplementation compared to placebo supplementation.
Oxygen consumption will be measured during submaximal constant load cycle exercise testing.
Measured: 1 Week
Difference in peripheral locomotor muscle oxygenation following dietary nitrate supplementation compared to placebo supplementation.
Peripheral locomotor muscle oxygenation will be monitored using near-infrared spectroscopy during submaximal constant load exercise testing.
Measured: 1 Week
Difference in post-exercise quadriceps fatigue following dietary nitrate supplementation compared to placebo supplementation.
Quadriceps fatigue will be assessed by measuring the quadriceps muscle force output using the femoral magnetic stimulation technique immediately before and after submaximal constant load exercise testing.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start7 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Guenette, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299945
- Sponsor's protocol ID
- H19-02552
- Status last verified
- May 2026
- First submitted
- 5 Mar 2020
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Nitrate Supplementation on Exercise Tolerance in Patients With Fibrotic Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT04299945
- Acronym / sponsor ID
- H19-02552
- Conditions
- Interstitial Lung Disease
- Keywords
- ILD, Nitrates, exercise, interstitial lung disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Mar 2020 (actual)
- 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.
Exercise training as part of a structured pulmonary rehabilitation program is a key factor in improving quality of life and symptoms in people with interstitial lung disease (ILD). Optimal methods of exercise training are yet to be explored in ILD. Drinking beetroot juice, which is rich in nitrate, has been shown to improve exercise performance in a variety of groups, but its effects in ILD have not been tested. The purpose of this study is to determine if drinking nitrate-rich beetroot juice can improve exercise performance compared to drinking nitrate-free beetroot juice in people with ILD.
Detailed description
PURPOSE:
The primary purpose of this study is to determine the effects of dietary nitrate supplementation on submaximal cycle exercise performance in patients with fibrotic ILD.
HYPOTHESIS:
Our primary hypothesis is that dietary nitrate supplementation will result in greater improvement in submaximal cycle exercise endurance time compared with placebo.
JUSTIFICATION:
Fibrotic interstitial lung disease (ILD) is a heterogeneous group of disorders that cause scarring/fibrosis or inflammation of the lungs, resulting in significant morbidity and high mortality. Almost all ILDs are characterized by dyspnoea and functional limitation and there are few effective and/or well-tolerated pharmacotherapies for many ILD subtypes.
Exertional dyspnoea leads to reduced exercise capacity in ILD, and this functional limitation is further worsened by skeletal muscle weakness and dysfunction. Both dyspnoea and poor exercise tolerance are strongly associated with quality of life and mortality in ILD and thus improving dyspnoea and functional capacity are important goals in the management of ILD.
Pulmonary rehabilitation is a structured evidence-based exercise and education intervention that is recommended for most patients with ILD. Pulmonary rehabilitation improves dyspnoea, functional capacity, and quality of life in patients with ILD; however, these benefits are often modest and only temporary. The exercise component of pulmonary rehabilitation is the predominant mediator of benefit; however, there are no studies that have investigated the optimal method of exercise training in patients with ILD. Thus, there is a clear need to identify new strategies that can provide larger and more persistent benefits from pulmonary rehabilitation.
Nitric oxide (NO) is a physiological signaling molecule that plays a critical role in vascular control. There is accumulating evidence that dietary nitrate, consumed in the form of beetroot juice, can increase the bioavailability of NO and subsequently enhance exercise performance in healthy, elite athlete, as well as diseased populations. These improvements may be related, but not limited to, enhanced efficiency of locomotion, peripheral locomotor oxygen delivery, and/or muscle power. The specific effects of dietary nitrate supplementation in ILD patients has yet to be explored. However, there is great potential for the use of this dietary supplement to improve exercise tolerance during, and improve patient outcomes from, pulmonary rehabilitation.
STATISTICAL ANALYSIS:
A p value <0.05 will be considered significant for all analyses. Data analysis will be performed using Microsoft Excel 2013 (Microsoft Corporation, Redmond, Washington, US) and Stata v12 (StataCorp, Texas, US).
Primary outcome: The primary outcome of cycle endurance time will be based on the duration patients were able to exercise during the constant work rate exercise test. A t-test will be used to compare endurance times between the intervention and placebo conditions.
The investigators have chosen to power this study based on the primary outcome of change in cycle exercise endurance time. Based on previously collected data in our laboratory in patients with ILD that show a standard deviation of 289.96 seconds for a 75% constant work rate cycle exercise test with a conservative between test correlation of 0.90, the investigators calculated that 15 participants would be needed to detect the minimal clinically important difference of 105 seconds between conditions assuming a two-sided α of 0.05 and 80% power.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function
| Arm | Type | Receives |
|---|---|---|
| Dietary nitrate supplementation | Experimental | Dietary Supplement: concentrated beetroot juice (400mg of nitrate per serving)The dietary nitrate supplement will be a concentrated, nitrate-rich beetroot juice (70 ml providing ∼400mg nitrate per serving) |
| Placebo | Placebo comparator | Dietary Supplement: concentrated beetroot juice (trace amounts of nitrate per serving)The placebo will be a concentrated, nitrate-depleted beetroot juice (70 ml with trace amounts of nitrate) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses
- Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
- Oxygen saturation ≥92% by pulse oximetry at rest while breathing room air
- Clinically stable for the preceding 6 weeks
- Can fluently read and write in English
Key exclusion criteria (5 listed)
- Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease) (see Table 4 from ERS/ATS consensus statement)
- Other significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
- FVC <50% or DLCO <25%
- Use of prednisone >10 mg/day for >2 weeks within 3 months of the first study visit
- Cardiac pacemaker or any metal or electronics inside of the body
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 |
|---|---|---|
| concentrated beetroot juice (400mg of nitrate per serving)Dietary nitrate supplementation includes consumption of two beverages daily for 7 consecutive days. | Dietary supplement | Dietary nitrate supplementation |
| concentrated beetroot juice (trace amounts of nitrate per serving)Dietary placebo supplementation includes consumption of two beverages daily for 7 consecutive days. | Dietary supplement | Placebo |
Primary outcome
Difference in submaximal cycle exercise endurance time following dietary nitrate supplementation compared to placebo supplementation.
Time frame: 1 Week
Exercise endurance time will be measured during submaximal constant load cycle exercise testing.
7 secondary outcomes
Difference in exertional dyspnoea during submaximal cycle exercise following dietary nitrate supplementation compared to placebo supplementation.
Time frame: 1 Week
Difference in exertional dyspnoea during activities of daily living following dietary nitrate supplementation compared to placebo supplementation.
Time frame: 1 Week
Difference in concentration of plasma nitrate ([NO3-]) and nitrite ([NO2-]) following dietary nitrate supplementation compared to placebo supplementation.
Time frame: 1 Week
Difference in resting, exercise, and post-exercise blood pressure following dietary nitrate supplementation compared to placebo supplementation.
Time frame: 1 Week
Difference in oxygen cost of submaximal cycle exercise following dietary nitrate supplementation compared to placebo supplementation.
Time frame: 1 Week
Difference in peripheral locomotor muscle oxygenation following dietary nitrate supplementation compared to placebo supplementation.
Time frame: 1 Week
Difference in post-exercise quadriceps fatigue following dietary nitrate supplementation compared to placebo supplementation.
Time frame: 1 Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing concentrated beetroot juice (400mg of nitrate per serving) and concentrated beetroot juice (trace amounts of nitrate per serving) in people with Interstitial Lung Disease, run by University of British Columbia at 2 sites in Canada.
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 5 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: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Ferguson, MSc (604-806-8835, Olivia.Ferguson@hli.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in submaximal cycle exercise endurance time following dietary nitrate supplementation compared to placebo supplementation. (time frame: 1 Week). 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 18 May 2026.