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Trial record 2 of 528 for:    NITRATE ION

Dietary Nitrate in COPD (CHB-BRJ-COPD)

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ClinicalTrials.gov Identifier: NCT02148289
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : June 5, 2014
Sponsor:
Collaborator:
University College Dublin
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Dietary Supplement: Nitrate rich beverage Dietary Supplement: Nitrate free beverage Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Dietary Nitrate in COPD: A Double-blind, Randomized, Placebo-controlled, Crossover Trial
Study Start Date : November 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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 Name: 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 Name: Placebo beverage




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02148289


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

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Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT02148289     History of Changes
Other Study ID Numbers: CHB-BRJ-COPD
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: June 2014
Keywords provided by Royal College of Surgeons, Ireland:
COPD, beetroot, dietary nitrate, nitric oxide
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases