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A 2 Week, Crossover Trial of Dietary Nitrate in Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Dietary nitrate
Placebo
Sponsored by
Royal College of Surgeons, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically stable,
  • Diagnosed with COPD
  • Ambulatory out-patients

Exclusion Criteria:

  • Long term oxygen therapy
  • Pulmonary hypertension
  • Active cardiovascular disease
  • Active skeletal conditions
  • Taking vasodilators
  • Diabetes mellitus

Sites / Locations

  • Respiratory & Sleep Diagnostics Department, Connolly Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nitrate rich beetroot juice

Nitrate depleted placebo beetroot juice

Arm Description

Concentrated, beetroot juice is a rich source of dietary nitrate.

Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.

Outcomes

Primary Outcome Measures

Change in incremental shuttle walk test distance

Secondary Outcome Measures

Change in plasma nitrate
Assessed by chemiluminescence
Change in ambulatory blood pressure
Change in quality of life
Quality of Life will be assessed with the Clinical COPD Questionnaire
Change in forced expiratory volume
Assessed by spirometry
Change in inflammatory markers
Assessed by C-reactive protein
Change in forced vital capacity
Assessed by spirometry
Change in plasma nitrate and nitrite
Assessed by chemiluminescence

Full Information

First Posted
January 7, 2015
Last Updated
October 22, 2015
Sponsor
Royal College of Surgeons, Ireland
Collaborators
University College Dublin, Connolly Hospital Blanchardstown
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1. Study Identification

Unique Protocol Identification Number
NCT02521532
Brief Title
A 2 Week, Crossover Trial of Dietary Nitrate in Chronic Obstructive Pulmonary Disease
Official Title
Dietary Nitrate for COPD: a 14d, Randomized, Placebo-controlled, Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal College of Surgeons, Ireland
Collaborators
University College Dublin, Connolly Hospital Blanchardstown

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in obstructive sleep apnea syndrome (OSAS) has not been reported.
Detailed Description
Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in OSAS has not been reported. The investigators hypothesize that chronic nitrate consumption might increase exercise tolerance, and exhaled NO but decrease blood pressure and have little impact on quality of life and pulmonary function. This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint exercise tolerance, pulmonary function, quality of life and ambulatory blood pressure will be assessed in conjunction with demographics and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitrate rich beetroot juice
Arm Type
Experimental
Arm Description
Concentrated, beetroot juice is a rich source of dietary nitrate.
Arm Title
Nitrate depleted placebo beetroot juice
Arm Type
Placebo Comparator
Arm Description
Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary nitrate
Other Intervention Name(s)
Beetroot juice
Intervention Description
140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Nitrate depleted beetroot juice
Intervention Description
140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
Primary Outcome Measure Information:
Title
Change in incremental shuttle walk test distance
Time Frame
Day 1, day 15 and day 29
Secondary Outcome Measure Information:
Title
Change in plasma nitrate
Description
Assessed by chemiluminescence
Time Frame
Day 1, day 15 and day 29
Title
Change in ambulatory blood pressure
Time Frame
Day 1, day 15 and day 29
Title
Change in quality of life
Description
Quality of Life will be assessed with the Clinical COPD Questionnaire
Time Frame
Day 1, day 15 and day 29
Title
Change in forced expiratory volume
Description
Assessed by spirometry
Time Frame
Day 1, day 15 and day 29
Title
Change in inflammatory markers
Description
Assessed by C-reactive protein
Time Frame
Day 1, day 15 and day 29
Title
Change in forced vital capacity
Description
Assessed by spirometry
Time Frame
Day 1, day 15 and day 29
Title
Change in plasma nitrate and nitrite
Description
Assessed by chemiluminescence
Time Frame
Day 1, day 15 and day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically stable, Diagnosed with COPD Ambulatory out-patients Exclusion Criteria: Long term oxygen therapy Pulmonary hypertension Active cardiovascular disease Active skeletal conditions Taking vasodilators Diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liam Cormican, MD
Organizational Affiliation
Respiratory & Sleep Diagnostics Department, Connolly Hospital, Dublin 15, Ireland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory & Sleep Diagnostics Department, Connolly Hospital
City
Dublin
ZIP/Postal Code
D15
Country
Ireland

12. IPD Sharing Statement

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A 2 Week, Crossover Trial of Dietary Nitrate in Chronic Obstructive Pulmonary Disease

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