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

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ClinicalTrials.gov Identifier: NCT02521532
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : October 23, 2015
Sponsor:
Collaborators:
University College Dublin
Connolly Hospital Blanchardstown
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Dietary Supplement: Dietary nitrate Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Dietary Nitrate for COPD: a 14d, Randomized, Placebo-controlled, Crossover Trial
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Nitrate rich beetroot juice
Concentrated, beetroot juice is a rich source of dietary nitrate.
Dietary Supplement: Dietary nitrate
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.
Other Name: Beetroot juice

Placebo Comparator: Nitrate depleted placebo beetroot juice
Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
Dietary Supplement: Placebo
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.
Other Name: Nitrate depleted beetroot juice




Primary Outcome Measures :
  1. Change in incremental shuttle walk test distance [ Time Frame: Day 1, day 15 and day 29 ]

Secondary Outcome Measures :
  1. Change in plasma nitrate [ Time Frame: Day 1, day 15 and day 29 ]
    Assessed by chemiluminescence

  2. Change in ambulatory blood pressure [ Time Frame: Day 1, day 15 and day 29 ]
  3. Change in quality of life [ Time Frame: Day 1, day 15 and day 29 ]
    Quality of Life will be assessed with the Clinical COPD Questionnaire

  4. Change in forced expiratory volume [ Time Frame: Day 1, day 15 and day 29 ]
    Assessed by spirometry

  5. Change in inflammatory markers [ Time Frame: Day 1, day 15 and day 29 ]
    Assessed by C-reactive protein

  6. Change in forced vital capacity [ Time Frame: Day 1, day 15 and day 29 ]
    Assessed by spirometry

  7. Change in plasma nitrate and nitrite [ Time Frame: Day 1, day 15 and day 29 ]
    Assessed by chemiluminescence



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521532


Locations
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Ireland
Respiratory & Sleep Diagnostics Department, Connolly Hospital
Dublin, Ireland, D15
Sponsors and Collaborators
Royal College of Surgeons, Ireland
University College Dublin
Connolly Hospital Blanchardstown
Investigators
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Principal Investigator: Liam Cormican, MD Respiratory & Sleep Diagnostics Department, Connolly Hospital, Dublin 15, Ireland

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Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT02521532     History of Changes
Other Study ID Numbers: Chronic NO3- in COPD
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases