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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04299945
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of British Columbia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease
Additional Details

PURPOSE: The primary purpose of this study is to determine the effects of dietary nitrate supplementation on submaximal cycle exercise performance in patients with fibrotic ILD. HYPOTHESIS: Our primary hypothesis is that dietary nitrate supplementation will result in greater improvement in submaximal cycle exercise endurance time compared with placebo. JUSTIFICATION: Fibrotic interstitial lung disease (ILD) is a heterogeneous group of disorders that cause scarring/fibrosis or inflammation of the lungs, resulting in significant morbidity and high mortality. Almost all ILDs are characterized by dyspnoea and functional limitation and there are few effective and/or well-tolerated pharmacotherapies for many ILD subtypes. Exertional dyspnoea leads to reduced exercise capacity in ILD, and this functional limitation is further worsened by skeletal muscle weakness and dysfunction. Both dyspnoea and poor exercise tolerance are strongly associated with quality of life and mortality in ILD and thus improving dyspnoea and functional capacity are important goals in the management of ILD. Pulmonary rehabilitation is a structured evidence-based exercise and education intervention that is recommended for most patients with ILD. Pulmonary rehabilitation improves dyspnoea, functional capacity, and quality of life in patients with ILD; however, these benefits are often modest and only temporary. The exercise component of pulmonary rehabilitation is the predominant mediator of benefit; however, there are no studies that have investigated the optimal method of exercise training in patients with ILD. Thus, there is a clear need to identify new strategies that can provide larger and more persistent benefits from pulmonary rehabilitation. Nitric oxide (NO) is a physiological signaling molecule that plays a critical role in vascular control. There is accumulating evidence that dietary nitrate, consumed in the form of beetroot juice, can increase the bioavailability of NO and subsequently enhance exercise performance in healthy, elite athlete, as well as diseased populations. These improvements may be related, but not limited to, enhanced efficiency of locomotion, peripheral locomotor oxygen delivery, and/or muscle power. The specific effects of dietary nitrate supplementation in ILD patients has yet to be explored. However, there is great potential for the use of this dietary supplement to improve exercise tolerance during, and improve patient outcomes from, pulmonary rehabilitation. STATISTICAL ANALYSIS: A p value <0.05 will be considered significant for all analyses. Data analysis will be performed using Microsoft Excel 2013 (Microsoft Corporation, Redmond, Washington, US) and Stata v12 (StataCorp, Texas, US). Primary outcome: The primary outcome of cycle endurance time will be based on the duration patients were able to exercise during the constant work rate exercise test. A t-test will be used to compare endurance times between the intervention and placebo conditions. The investigators have chosen to power this study based on the primary outcome of change in cycle exercise endurance time. Based on previously collected data in our laboratory in patients with ILD that show a standard deviation of 289.96 seconds for a 75% constant work rate cycle exercise test with a conservative between test correlation of 0.90, the investigators calculated that 15 participants would be needed to detect the minimal clinically important difference of 105 seconds between conditions assuming a two-sided α of 0.05 and 80% power.

Arms & Interventions

Arms

Experimental: Dietary nitrate supplementation

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

Placebo Comparator: Placebo

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

Interventions

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

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

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Vancouver, British Columbia, Canada

Status

Recruiting

Address

Providence Health Care - St. Paul's Hosptial

Vancouver, British Columbia, V6Z 1Y6

Site Contact

Jordan Guenette, Ph.D

jordan.guenette@hli.ubc.ca

604-682-2344

Vancouver Coastal Health, Vancouver, Canada

Status

Recruiting

Address

Vancouver Coastal Health

Vancouver, , V5Z 1M9