Dietary Nitrate in COPD

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Dietary Supplement: Nitrate rich beverage; Dietary Supplement: Nitrate free beverage

• Registration Number: NCT02148289
• Lead Sponsor: Royal College of Surgeons, Ireland

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-04
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nitrate rich beverage	Nitrate rich beverage	Nitrate rich beverage will contain 140ml nitrate rich beetroot juice + 200ml blackcurrant juice containing 12.7mmol nitrate
Nitrate free beverage	Nitrate free beverage	Nitrate free beverage will 140ml water + 200ml blackcurrant juice containing \<0.5mmol nitrate

Primary Outcome Measures

Name	Time	Method
Change in Incremental Shuttle Walk Test Distance	day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h	The 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.