Beetroot Juice for IPF Patients: A Pilot Test of Nitrate-Rich Supplementation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the feasibility and effects of short-term nitrate-rich beetroot juice supplementation in adults with idiopathic pulmonary fibrosis (IPF). Participants will receive approximately 400 mg nitrate per 70 ml serving, twice a day for 3 days. The trial leverages prior findings that exercise training improves capacity in IPF and that nitrite dynamics respond to exercise, exploring whether beetroot-derived nitrate can modulate this response. Outcomes focus on exercise tolerance, breathlessness, and redox-related markers, within a predefined clinical safety framework. The study is conducted at University Hospital Southampton with NIHR and AAIR collaboration.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital Southampton
  Southampton, United Kingdom Recruiting

Study contacts

• Study coordinator: Tim JM Wallis, MD, PhD
• Email: tim.wallis@uhs.nhs.uk
• Phone: 023 8120 4479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.