BEET-IPF

• Research type

  Research Study

• Full title

  Pilot study of nitrate-rich beetroot juice supplementation in patients with idiopathic pulmonary fibrosis

• IRAS ID

  343592

• Contact name

  Timothy John Merrill Wallis

• Contact email

  tim.wallis@uhs.nhs.uk

• Sponsor organisation

  University Hospital Southampton

• Clinicaltrials.gov Identifier

  NCT06488638

• Duration of Study in the UK

  2 years, 7 months, 3 days

• Research summary

  Idiopathic pulmonary fibrosis (IPF) is a type of scarring (fibrotic) luroung disease. Reduced exercise capacity is a key symptom experienced by patients. In previous research we 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 we 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 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

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  24/SC/0346

• Date of REC Opinion

  5 Dec 2024

• REC opinion

  Further Information Favourable Opinion