Dietary Nitrate in COPD (CHB-BRJ-COPD)

June 4, 2014 updated by: Royal College of Surgeons, Ireland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitrate rich beverage
Nitrate rich beverage will contain 140ml nitrate rich beetroot juice + 200ml blackcurrant juice containing 12.7mmol nitrate
Dietary supplement: 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.
Other Names:
  • Nitrate rich beetroot juice
Placebo Comparator: Nitrate free beverage
Nitrate free beverage will 140ml water + 200ml blackcurrant juice containing <0.5mmol nitrate
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.
Other Names:
  • Placebo beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Incremental Shuttle Walk Test Distance
Time Frame: 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.
day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting blood pressure
Time Frame: 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.
day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Collaborators

University College Dublin

Investigators

  • Study Director: Conor P Kerley, BSc, University College Dublin
  • Principal Investigator: Liam J Cormican, MD, Royal College of Surgeons in Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB-BRJ-COPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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