Effects of Drinking Beetroot Juice on Exercise Performance in Patients With Fibrotic Interstitial Lung Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia

About this trial

Exercise training as part of a structured pulmonary rehabilitation program is a key factor in improving quality of life and symptoms in people with interstitial lung disease (ILD). Optimal methods of exercise training are yet to be explored in ILD. Drinking beetroot juice, which is rich in nitrate, has been shown to improve exercise performance in a variety of groups, but its effects in ILD have not been tested. The purpose of this study is to determine if drinking nitrate-rich beetroot juice can improve exercise performance compared to drinking nitrate-free beetroot juice in people with ILD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses

Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis

Oxygen saturation ≥92% by pulse oximetry at rest while breathing room air

Clinically stable for the preceding 6 weeks

Disqualifiers

Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease) (see Table 4 from ERS/ATS consensus statement)

Other significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation

FVC <50% or DLCO <25%

Use of prednisone >10 mg/day for >2 weeks within 3 months of the first study visit

Trial design

Design model

Crossover

Treatments tested in this trial

  • concentrated beetroot juice (400mg of nitrate per serving)

    Dietary supplement

    Dietary nitrate supplementation includes consumption of two beverages daily for 7 consecutive days.

  • concentrated beetroot juice (trace amounts of nitrate per serving)

    Dietary supplement

    Dietary placebo supplementation includes consumption of two beverages daily for 7 consecutive days.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Dietary nitrate supplementationExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Difference in submaximal cycle exercise endurance time following dietary nitrate supplementation compared to placebo supplementation.

Exercise endurance time will be measured during submaximal constant load cycle exercise testing.

Time frame
1 Week

Secondary outcomes

1

Difference in exertional dyspnoea during submaximal cycle exercise following dietary nitrate supplementation compared to placebo supplementation.

Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed at rest and every 1 minute during submaximal constant load cycle exercise testing until exhaustion.

Time frame
1 Week
2

Difference in exertional dyspnoea during activities of daily living following dietary nitrate supplementation compared to placebo supplementation.

Shortness of breath during daily living patterns will be assessed using established questionnaires.

Time frame
1 Week
3

Difference in concentration of plasma nitrate ([NO3-]) and nitrite ([NO2-]) following dietary nitrate supplementation compared to placebo supplementation.

Blood samples will be taken and analyzed for the concentration levels of nitrates in blood plasma.

Time frame
1 Week
4

Difference in resting, exercise, and post-exercise blood pressure following dietary nitrate supplementation compared to placebo supplementation.

Blood pressure will be measured using a manual sphygmomanometer at rest, every 2 minutes during submaximal constant load cycle exercise testing until exhaustion, and 5 minutes after exercise ends.

Time frame
1 Week

Other outcomes

Sponsors and contacts

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