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

Sponsor
University Hospital Southampton NHS Foundation Trust
Study ID
NCT06488638
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis
  • Interstitial Lung Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • nitrate-rich beetroot juice (70ml with approx. 400 mg nitrate) twice a day for 3 days — DIETARY_SUPPLEMENT
    commercially available beetroot juice dietary nitrate supplement

Study Details

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

Key Dates

First listed
Jul 5, 2024
Start date
Feb 13, 2026
Status verified
Jun 2026
Primary completion
Jun 3, 2027
Completion
Jun 3, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    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
  • Placebo Comparator: Group B
    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

Primary Outcome Measure

endurance time [ Time Frame: From end of treatment period 1 to end of treatment period 2 (minimum 10 days) ]

Central Contacts

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