NCT06488638Recruiting
Pilot Study of Nitrate-rich Beetroot Juice Supplementation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 26 Jun 2024
- Start date
- 13 Feb 2026
- Primary completion date
- 3 Jun 2027
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT06488638
What you commit to
- Study type: Interventional
- Planned participants: 16
- From 13 Feb 2026 to the primary completion date, 3 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
- 1\) 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.
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Southampton Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.