NCT06488638 Pilot Study of Nitrate-rich Beetroot Juice Supplementation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
| NCT ID | NCT06488638 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Southampton NHS Foundation Trust |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2027-06-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2026-02-13 with a primary completion date of 2027-06-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Eligibility Criteria
IPF Patients: Inclusion Criteria 1. Patients aged 18-85 years with a prior specialist multidisciplinary team diagnosis of idiopathic pulmonary fibrosis (IPF) based on current established consensus guidelines. 2. Medical Research Council (MRC) breathlessness grade 1-3 3. Judged clinically stable for 3 months prior to recruitment by the investigator. IPF Patients: Exclusion Criteria 1. Baseline spirometry with FEV1/FVC ratio \< 0.7. 2. Neoplastic disease undergoing treatment or active follow up. 3. Presence of infection or exacerbation requiring hospitalization, within last 3 months. 4. Current tobacco smoker or use of nicotine containing vapes (within 3 months) 5. Current use of ambulatory or long-term oxygen therapy (LTOT). 6. Peripheral oxygen saturations \<85% during 6-minute walk-test. 7. Any condition which would prevent completion of cycle-ergometer testing, pulmonary function testing (PFT) or 6-minute walk testing as judged by the investigator. 8. Participation in a pulmonary rehabilitation (PR) program in the last 3 months. 9. Any condition excluding CPET based on the absolute contraindication as the ACCP/ATS guidelines 2003 10. Positive pregnancy test in females of childbearing age. 11. Symptomatic peripheral vascular disease 12. 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 1. Inability to give informed written consent. 2. Malignancy (except localised squamous or basal cell skin carcinoma) undergoing active investigation, treatment, or follow-up. 3. Significant cardiorespiratory disease as judged by the investigator. 4. Diabetes mellitus requiring treatment with pharmacology therapy. 5. Current tobacco smoker or use of nicotine containing vapes (within three months). 6. Symptomatic peripheral vascular disease. 7. Concomitant use of nitrate-based medicine or phosphodiesterase V inhibitors.
Contact & Investigator
Tim JM Wallis, MD, PhD
STUDY CHAIR
University Hospital Southampoton
Frequently Asked Questions
Who can join the NCT06488638 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06488638 currently recruiting?
Yes, NCT06488638 is actively recruiting participants. Contact the research team at tim.wallis@uhs.nhs.uk for enrollment information.
Where is the NCT06488638 trial being conducted?
This trial is being conducted at Southampton, United Kingdom.
Who is sponsoring the NCT06488638 clinical trial?
NCT06488638 is sponsored by University Hospital Southampton NHS Foundation Trust. The principal investigator is Tim JM Wallis, MD, PhD at University Hospital Southampoton. The trial plans to enroll 16 participants.