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Pilot Study of Nitrate-rich Beetroot Juice Supplementation in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study acronym: BEET-IPF
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Sep 2025 to Jun 3, 2027 · Start date changed from estimate of Sep 2024 to Feb 13, 2026 · Study sites: 0 to 1 · 4 morev2 Show 7 more changesShow less
    • Primary completion date: Sep 2025 to Jun 3, 2027
    • Start date changed from estimate of Sep 2024 to Feb 13, 2026
    • Study sites: 0 to 1
    • Completion date: Sep 2026 to Jun 3, 2027
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06488638
Lead Sponsor University Hospital Southampton NHS Foundation Trust
Collaborators: NIHR Southampton Respiratory Biomedical Research Centre, Asthma, Allergy and Inflammation Research (AAIR) Charity
Conditions Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov