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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• 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.

⁃ 1\) Age and sex-matched to participants in the IPF cohort. Note: the participants will be age-matched within a 5-year age bracket.

Locations
Other Locations
United Kingdom
University Hospital Southampton
RECRUITING
Southampton
Contact Information
Primary
Tim JM Wallis, MD, PhD
tim.wallis@uhs.nhs.uk
023 8120 4479
Time Frame
Start Date: 2026-02-13
Estimated Completion Date: 2027-06-03
Participants
Target number of participants: 16
Treatments
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
Sponsors
Collaborators: NIHR Southampton Respiratory Biomedical Research Centre, Asthma, Allergy and Inflammation Research (AAIR) Charity
Leads: University Hospital Southampton NHS Foundation Trust

This content was sourced from clinicaltrials.gov