Idiopathic Pulmonary FibrosisBEET-IPFNCT06488638
Pilot Study of Nitrate-rich Beetroot Juice Supplementation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A study testing nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days in people with Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Idiopathic pulmonary fibrosis (IPF) is a type of scarring (fibrotic) lung disease. Reduced exercise capacity is a key symptom experienced by patients. In previous research the investigators identified that an interval-based exercise programme led to significant improvements in exercise capacity (Wallis et al… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
- What is being tested?
- nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2026to 3 Jun 2027
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
IPF Patients: Inclusion Criteria
- Patients aged 18-85 years with a prior specialist multidisciplinary team diagnosis of idiopathic pulmonary fibrosis (IPF) based on current established consensus guidelines.
- Medical Research Council (MRC) breathlessness grade 1-3
- Judged clinically stable for 3 months prior to recruitment by the investigator.
IPF Patients: Exclusion Criteria
- Baseline spirometry with FEV1/FVC ratio < 0.7.
- Neoplastic disease undergoing treatment or active follow up.
- Presence of infection or exacerbation requiring hospitalization, within last 3 months.
- Current tobacco smoker or use of nicotine containing vapes (within 3 months)
- Current use of ambulatory or long-term oxygen therapy (LTOT).
- Peripheral oxygen saturations <85% during 6-minute walk-test.
- Any condition which would prevent completion of cycle-ergometer testing, pulmonary function testing (PFT) or 6-minute walk testing as judged by the investigator.
- Participation in a pulmonary rehabilitation (PR) program in the last 3 months.
- Any condition excluding CPET based on the absolute contraindication as the ACCP/ATS guidelines 2003
- Positive pregnancy test in females of childbearing age.
- Symptomatic peripheral vascular disease
- Concomitant use of nitrate-based medicine or phosphodiesterase V inhibitors
Controls: Inclusion Criteria
- Age and sex-matched to participants in the IPF cohort. Note: the participants will be age-matched within a 5-year age bracket.
Controls: Exclusion Criteria
- Inability to give informed written consent.
- Malignancy (except localised squamous or basal cell skin carcinoma) undergoing active investigation, treatment, or follow-up.
- Significant cardiorespiratory disease as judged by the investigator.
- Diabetes mellitus requiring treatment with pharmacology therapy.
- Current tobacco smoker or use of nicotine containing vapes (within three months).
- Symptomatic peripheral vascular disease.
- Concomitant use of nitrate-based medicine or phosphodiesterase V inhibitors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton
Southampton, SO16 6YD
Tim Wallis, +44 23 8120 4479, RespiratoryResearch@uhs.nhs.uk
Ngu Khine
About this study
Idiopathic pulmonary fibrosis (IPF) is a type of scarring (fibrotic) lung disease. Reduced exercise capacity is a key symptom experienced by patients. In previous research the investigators identified that an interval-based exercise programme led to significant improvements in exercise capacity (Wallis et al Antioxidants. 2023).
An unexpected finding was that in patients with IPF, exercise led to a reduction in blood nitrite concentrations an observation the investigators did not see in non-affected individuals. Research has identified that nitrite concentrations are expected to increase after exercise and the size of this increase is related to an individual's exercise capacity. There is also evidence from healthy individuals and patients with chronic obstructive pulmonary disease (COPD) that nitrate supplementation (a source of nitrite) improves response to exercise training. However, in both these groups an exercise-induced fall in blood nitrite concentrations has not been observed. Hence our finding of an exercise-induced fall in blood nitrite levels in IPF patients suggest that they may be especially sensitive to supplementation with nitrate, commercially available as nitrate-rich beetroot juice (NRBJ).
Read more
This current study investigates this in a pilot placebo-controlled, double-blind, randomised, cross-over study of NRBJ on exercise capacity in IPF patients.
Aims In patients with IPF
- Quantify the effect of nitrate supplementation on exercise capacity
- Determine the effect of nitrate supplementation on blood markers of nitric oxide production/metabolism.
- Determine the effect of nitrate supplementation on forearm blood flow. Sample size: n=8 IPF patients, aged 18-85years and medical research breathlessness scale 1-3 Intervention: 3-days (two-times daily) NRBJ or nitrate-depleted placebo juice (both commercially available) with subsequent constant-load exercise test (Primary outcome). Following at least 1 week wash-out period participants will cross-over and repeat.
A cohort (n=8) of age, sex-matched controls without IPF will be enrolled for comparison of forearm blood flow and pre-exercise venous blood samples for biomarkers comparison only.
Number of sites: 1
Read the detailed description
Idiopathic pulmonary fibrosis (IPF) is the prototypic chronic progressive fibrotic interstitial lung disease (ILD). Progressive disease is characterised by breathlessness and exercise limitation and there is an unmet need for interventions which improve patient's quality of life. Increasing exercise intolerance in patients with ILD is associated with worsening quality of life and loss of independence. Pulmonary rehabilitation is recommended by the National Institute for health and Care Excellence (NICE) for patients with ILD, however individual responses to exercise training are variable and optimal training strategies are yet to be established.
In previous published research (Wallis et al. 2023. Antioxidants) the investigators studied the effect of an individually prescribed, interval-based aerobic exercise programme on redox status and functional capacity in patients with IPF. At baseline, IPF patients had evidence of increased oxidative stress. The individually prescribed exercise programme led to a significant increase in antioxidant buffering capacity together with clinically meaningful improvements in exercise capacity and medical research council (MRC) breathlessness score. Notably, the investigators also identified that in patients with IPF, exercise induced a significant fall in circulating nitrite concentrations, an effect potentiated by exercise training. In contrast, control individuals exhibited a post-exercise increase in nitrite concentrations due to shear stress-induced nitric oxide (NO)-synthase stimulation.
Nitric oxide (NO) physiology is strongly implicated in the physiology of exercise performance. In healthy individuals the delta of the post-exercise increase in circulating nitrite concentration positively correlates with peak exercise capacity and it has been identified that supplementation with nitrate significantly lowers the oxygen cost (oxygen uptake [V̇O2] required to perform a given work-rate) of submaximal exercise. Recent evidence from patients with COPD has identified that sustained supplementation with nitrate-rich beetroot juice augmented the effect of pulmonary rehabilitation compared to placebo (+30m in incremental shuttle walk test). However, in contrast to our findings in IPF, within these groups no underlying dysregulation in nitrite utilisation during exercise has been identified i.e. exercise induced nitrite decrease is not present. This suggests that patients with IPF may be exquisitely sensitive to benefit from nitrate (known to serve as a source of nitrite) during exercise, a non-pharmacologic intervention with potential rapid translation into clinical practice.
Hypothesis
Nitrate supplementation (in the form of nitrate-rich beetroot juice drink) significantly improves submaximal exercise capacity in patients with IPF.
Here the investigators test this hypothesis in this study by way of a pilot randomised controlled double-blind cross-over study of nitrate supplementation on submaximal exercise capacity in patients with IPF. Together with a nested mechanistic study investigating the effect of nitrate supplementation on systemic blood markers of nitric oxide production and metabolism as well as forearm blood flow.
Aims and Objectives
In patients with IPF
- Quantify the effect of nitrate supplementation on submaximal exercise capacity (constant work-rate test).
- Determine the effect of nitrate supplementation on markers of nitric oxide (NO) production and metabolism pre- and post-exercise.
- Determine the effect of nitrate supplementation on forearm blood flow.
- Assess the effect of nitrate supplementation of participants' perceptions of exercise and quality of life
Study Design and setting Up to 8 patients with IPF will be recruited to this single centre cohort cross-over double-blind designed pilot study at a large NHS Foundation trust teaching hospital. Ongoing interim analysis will be conducted throughout the study.
Intervention Participants will be randomly assigned to either 3-days (two times daily) of nitrate-rich beetroot juice drink (daily dose of nitrate 800mg nitrate) or nitrate-depleted juice placebo control drink of identical taste and colour (Treatment Period 1) immediately prior to constant-load exercise test (see intervention). Following a wash-out period of at least 1-week they will cross-over and repeat (Treatment Period 2).
Control Cohort:
A cohort (n=8) of age and sex-matched controls without IPF will be enrolled for comparison of forearm blood flow by venous occlusion digital thermal imaging and pre-exercise venous blood samples for biomarkers of NO metabolism and oxidative stress.
End points: Endurance time, adverse events. Number of sites: 1
- Being tested
- nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 daysDietary supplement
commercially available beetroot juice dietary nitrate supplement
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Treatment period 1) nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days
Treatment period 2) placebo nitrate-depleted beetroot juice (70ml) twice a day for 3 days Receives: Dietary Supplement: nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days |
| Group B | Placebo comparator | Treatment period 1) placebo nitrate-depleted beetroot juice (70ml) twice a day for 3 days
Treatment period 2) nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days Receives: Dietary Supplement: nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
endurance time
fixed-load static cycle ergometry test
Measured: From end of treatment period 1 to end of treatment period 2 (minimum 10 days)
Secondary outcomes (2)
plasma nitrate and nitrite concentrations
venous blood samples
Measured: From end of treatment period 1 to end of treatment period 2 (minimum 10 days)
forearm blood flow
venous occlusion digital thermal imaging
Measured: From end of treatment period 1 to end of treatment period 2 (minimum 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start13 Feb 2026
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Model description
- placebo-controlled, double blind, randomised controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- NIHR Southampton Respiratory Biomedical Research Centre, Asthma, Allergy and Inflammation Research (AAIR) Charity
- Responsible party
- Sponsor
- Investigators
- Tim JM Wallis, MD, PhD, Study chair, University Hospital Southampoton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488638
- Sponsor's protocol ID
- RHMRESP0009
- Acronym
- BEET-IPF
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2024
- Last updated
- 6 Jul 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Nitrate-rich Beetroot Juice Supplementation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT06488638
- Acronym / sponsor ID
- BEET-IPF / RHMRESP0009
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- NIHR Southampton Respiratory Biomedical Research Centre, Asthma, Allergy and Inflammation Research (AAIR) Charity
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 5 Jul 2024 (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.
Idiopathic pulmonary fibrosis (IPF) is a type of scarring (fibrotic) lung disease. Reduced exercise capacity is a key symptom experienced by patients. In previous research the investigators identified that an interval-based exercise programme led to significant improvements in exercise capacity (Wallis et al Antioxidants. 2023).
An unexpected finding was that in patients with IPF, exercise led to a reduction in blood nitrite concentrations an observation the investigators did not see in non-affected individuals. Research has identified that nitrite concentrations are expected to increase after exercise and the size of this increase is related to an individual's exercise capacity. There is also evidence from healthy individuals and patients with chronic obstructive pulmonary disease (COPD) that nitrate supplementation (a source of nitrite) improves response to exercise training. However, in both these groups an exercise-induced fall in blood nitrite concentrations has not been observed. Hence our finding of an exercise-induced fall in blood nitrite levels in IPF patients suggest that they may be especially sensitive to supplementation with nitrate, commercially available as nitrate-rich beetroot juice (NRBJ).
This current study investigates this in a pilot placebo-controlled, double-blind, randomised, cross-over study of NRBJ on exercise capacity in IPF patients.
Aims In patients with IPF
- Quantify the effect of nitrate supplementation on exercise capacity
- Determine the effect of nitrate supplementation on blood markers of nitric oxide production/metabolism.
- Determine the effect of nitrate supplementation on forearm blood flow. Sample size: n=8 IPF patients, aged 18-85years and medical research breathlessness scale 1-3 Intervention: 3-days (two-times daily) NRBJ or nitrate-depleted placebo juice (both commercially available) with subsequent constant-load exercise test (Primary outcome). Following at least 1 week wash-out period participants will cross-over and repeat.
A cohort (n=8) of age, sex-matched controls without IPF will be enrolled for comparison of forearm blood flow and pre-exercise venous blood samples for biomarkers comparison only.
Number of sites: 1
Detailed description
Idiopathic pulmonary fibrosis (IPF) is the prototypic chronic progressive fibrotic interstitial lung disease (ILD). Progressive disease is characterised by breathlessness and exercise limitation and there is an unmet need for interventions which improve patient's quality of life. Increasing exercise intolerance in patients with ILD is associated with worsening quality of life and loss of independence. Pulmonary rehabilitation is recommended by the National Institute for health and Care Excellence (NICE) for patients with ILD, however individual responses to exercise training are variable and optimal training strategies are yet to be established.
In previous published research (Wallis et al. 2023. Antioxidants) the investigators studied the effect of an individually prescribed, interval-based aerobic exercise programme on redox status and functional capacity in patients with IPF. At baseline, IPF patients had evidence of increased oxidative stress. The individually prescribed exercise programme led to a significant increase in antioxidant buffering capacity together with clinically meaningful improvements in exercise capacity and medical research council (MRC) breathlessness score. Notably, the investigators also identified that in patients with IPF, exercise induced a significant fall in circulating nitrite concentrations, an effect potentiated by exercise training. In contrast, control individuals exhibited a post-exercise increase in nitrite concentrations due to shear stress-induced nitric oxide (NO)-synthase stimulation.
Nitric oxide (NO) physiology is strongly implicated in the physiology of exercise performance. In healthy individuals the delta of the post-exercise increase in circulating nitrite concentration positively correlates with peak exercise capacity and it has been identified that supplementation with nitrate significantly lowers the oxygen cost (oxygen uptake [V̇O2] required to perform a given work-rate) of submaximal exercise. Recent evidence from patients with COPD has identified that sustained supplementation with nitrate-rich beetroot juice augmented the effect of pulmonary rehabilitation compared to placebo (+30m in incremental shuttle walk test). However, in contrast to our findings in IPF, within these groups no underlying dysregulation in nitrite utilisation during exercise has been identified i.e. exercise induced nitrite decrease is not present. This suggests that patients with IPF may be exquisitely sensitive to benefit from nitrate (known to serve as a source of nitrite) during exercise, a non-pharmacologic intervention with potential rapid translation into clinical practice.
Hypothesis
Nitrate supplementation (in the form of nitrate-rich beetroot juice drink) significantly improves submaximal exercise capacity in patients with IPF.
Here the investigators test this hypothesis in this study by way of a pilot randomised controlled double-blind cross-over study of nitrate supplementation on submaximal exercise capacity in patients with IPF. Together with a nested mechanistic study investigating the effect of nitrate supplementation on systemic blood markers of nitric oxide production and metabolism as well as forearm blood flow.
Aims and Objectives
In patients with IPF
- Quantify the effect of nitrate supplementation on submaximal exercise capacity (constant work-rate test).
- Determine the effect of nitrate supplementation on markers of nitric oxide (NO) production and metabolism pre- and post-exercise.
- Determine the effect of nitrate supplementation on forearm blood flow.
- Assess the effect of nitrate supplementation of participants' perceptions of exercise and quality of life
Study Design and setting Up to 8 patients with IPF will be recruited to this single centre cohort cross-over double-blind designed pilot study at a large NHS Foundation trust teaching hospital. Ongoing interim analysis will be conducted throughout the study.
Intervention Participants will be randomly assigned to either 3-days (two times daily) of nitrate-rich beetroot juice drink (daily dose of nitrate 800mg nitrate) or nitrate-depleted juice placebo control drink of identical taste and colour (Treatment Period 1) immediately prior to constant-load exercise test (see intervention). Following a wash-out period of at least 1-week they will cross-over and repeat (Treatment Period 2).
Control Cohort:
A cohort (n=8) of age and sex-matched controls without IPF will be enrolled for comparison of forearm blood flow by venous occlusion digital thermal imaging and pre-exercise venous blood samples for biomarkers of NO metabolism and oxidative stress.
End points: Endurance time, adverse events. Number of sites: 1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo-controlled, double blind, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 daysTreatment period 1) nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days Treatment period 2) placebo nitrate-depleted beetroot juice (70ml) twice a day for 3 days |
| Group B | Placebo comparator | Dietary Supplement: nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 daysTreatment period 1) placebo nitrate-depleted beetroot juice (70ml) twice a day for 3 days Treatment period 2) nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 dayscommercially available beetroot juice dietary nitrate supplement | Dietary supplement | Group A, Group B |
Primary outcome
endurance time
Time frame: From end of treatment period 1 to end of treatment period 2 (minimum 10 days)
fixed-load static cycle ergometry test
2 secondary outcomes
plasma nitrate and nitrite concentrations
Time frame: From end of treatment period 1 to end of treatment period 2 (minimum 10 days)
forearm blood flow
Time frame: From end of treatment period 1 to end of treatment period 2 (minimum 10 days)
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 6 Jul 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.
Tim JM Wallis, MD, PhD study chair
University Hospital Southampoton
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-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days in people with Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Jul 2026. 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 United Kingdom. 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 Tim JM Wallis, MD, PhD (023 8120 4479, tim.wallis@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endurance time (time frame: From end of treatment period 1 to end of treatment period 2 (minimum 10 days)). 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 Jul 2026.