Dietary Nitrate in COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nitrate rich beverage

Nitrate rich beverage will contain 140ml nitrate rich beetroot juice + 200ml blackcurrant juice containing 12.7mmol nitrate

Group Type ACTIVE_COMPARATOR

Nitrate rich beverage

Intervention Type DIETARY_SUPPLEMENT

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

Nitrate free beverage

Nitrate free beverage will 140ml water + 200ml blackcurrant juice containing \<0.5mmol nitrate

Group Type PLACEBO_COMPARATOR

Nitrate free beverage

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Nitrate 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.

Intervention Type DIETARY_SUPPLEMENT

Nitrate 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nitrate rich beetroot juice Placebo beverage

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No