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

NCT04299945 | Recruiting

• 1 other identifier: H19-02552
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Interstitial Lung Disease

Keywords

ILD; Nitrates; exercise; interstitial lung disease

Outcome Measures

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.

  1 Week

Secondary Outcomes (7)

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

  1 Week

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

  1 Week

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

  1 Week

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

  1 Week

• Difference in oxygen cost of submaximal cycle exercise following dietary nitrate supplementation compared to placebo supplementation.

  1 Week

Study Arms (2)

Dietary nitrate supplementation

EXPERIMENTAL

The dietary nitrate supplement will be a concentrated, nitrate-rich beetroot juice (70 ml providing ∼400mg nitrate per serving)

Dietary Supplement: concentrated beetroot juice (400mg of nitrate per serving)

Placebo

PLACEBO COMPARATOR

The placebo will be a concentrated, nitrate-depleted beetroot juice (70 ml with trace amounts of nitrate)

Dietary Supplement: concentrated beetroot juice (trace amounts of nitrate per serving)

Interventions

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

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

Dietary nitrate supplementation

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

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

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Can fluently read and write in English

You may not qualify if:

• 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
• Cardiac pacemaker or any metal or electronics inside of the body

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

Providence Health Care - St. Paul's Hosptial

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Vancouver Coastal Health

Vancouver, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Behavior

Central Study Contacts

Olivia Ferguson, MSc

CONTACT

604-806-8835; Olivia.Ferguson@hli.ubc.ca

Dhillon Satvir, MSc

CONTACT

604-806-8835; satvir.dhillon@hli.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible participants will be randomly assigned using a computer-generated algorithm in a 1:1 ratio to dietary nitrate supplementation (concentrated beetroot juice) or placebo (the same amount of beetroot juice but with naturally occurring nitrate removed).
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiopulmonary Exercise Physiology Laboratory

Model Details: One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: August 7, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)