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Dietary Nitrate in COPD

Dietary Nitrate in COPD: A Double-blind, Randomized, Placebo-controlled, Crossover Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02148289
Acronym
CHB-BRJ-COPD
Enrollment
12
Registered
2014-05-28
Start date
2012-11-30
Completion date
2013-03-31
Last updated
2014-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, beetroot, dietary nitrate, nitric oxide

Brief summary

The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption, in the form of beetroot juice, might increase incremental shuttle walk test (ISWT) distance in COPD subjects.

Detailed description

Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in COPD subjects compared to a matched, low-nitrate drink. This study is a randomized, double-blind placebo-controlled, crossover trial. Resting blood pressure, phlebotomy and ISWT are performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage.

Interventions

DIETARY_SUPPLEMENTNitrate rich beverage

Following randomisation on day 1, subjects will consume either the nitrate or nitrate-free beverage and then the crossover beverage on day 8.

DIETARY_SUPPLEMENTNitrate free beverage

Following randomisation on day 1, subjects will consume either the nitrate or nitrate-free beverage and then the crossover beverage on day 8.

Sponsors

University College Dublin
CollaboratorOTHER
Royal College of Surgeons, Ireland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Information consenting out-patients with a previous physician diagnosis of COPD * Clinically stable * Ambulatory

Exclusion criteria

* Subjects who required supplemental oxygen for exercise * Subjects with pulmonary hypertension and angina * Intolerant to beetroot * Insulin dependent diabetes * Thyroid disease

Design outcomes

Primary

MeasureTime frameDescription
Change in Incremental Shuttle Walk Test Distanceday 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3hThe change between day 1, time 0 and day 1, time 3h will be compared to the changes between day 8, time 0 and day 8, time 3h.

Other

MeasureTime frameDescription
Resting blood pressureday 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3hThe change between day 1, time 0 and day 1, time 3h will be compared to the changes between day 8, time 0 and day 8, time 3h.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026