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Dietary Nitrate in COPD (CHB-BRJ-COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Nitrate rich beverage

Nitrate free beverage

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, beetroot, dietary nitrate, nitric oxide

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nitrate rich beverage

Nitrate free beverage

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Incremental Shuttle Walk Test Distance

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02148289

First Posted

May 19, 2014

Last Updated

June 4, 2014

Sponsor

Royal College of Surgeons, Ireland

Collaborators

University College Dublin

1. Study Identification

Unique Protocol Identification Number

NCT02148289

Brief Title

Dietary Nitrate in COPD

Acronym

CHB-BRJ-COPD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royal College of Surgeons, Ireland

Collaborators

University College Dublin

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, beetroot, dietary nitrate, nitric oxide

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nitrate rich beverage

Arm Type

Active Comparator

Arm Description

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

Arm Title

Nitrate free beverage

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Nitrate rich beverage

Other Intervention Name(s)

Nitrate rich beetroot juice

Intervention Description

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

Intervention Name(s)

Nitrate free beverage

Other Intervention Name(s)

Placebo beverage

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Incremental Shuttle Walk Test Distance

Description

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.

Time Frame

day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h

Other Pre-specified Outcome Measures:

Title

Resting blood pressure

Description

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.

Time Frame

day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Conor P Kerley, BSc

Organizational Affiliation

University College Dublin

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Liam J Cormican, MD

Organizational Affiliation

Royal College of Surgeons in Ireland

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Dietary Nitrate in COPD

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