Dietary Nitrate in COPD

NCT02148289 | Completed

• 1 other identifier: CHB-BRJ-COPD
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, beetroot, dietary nitrate, nitric oxide

Outcome Measures

Primary Outcomes (1)

• 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.

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

Other Outcomes (1)

• Resting blood pressure

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

Study Arms (2)

Nitrate rich beverage

ACTIVE COMPARATOR

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

Dietary Supplement: Nitrate rich beverage

Nitrate free beverage

PLACEBO COMPARATOR

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

Dietary Supplement: Nitrate free beverage

Interventions

Nitrate rich beverage DIETARY_SUPPLEMENT

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

Also known as: Nitrate rich beetroot juice

Nitrate rich beverage

Nitrate free beverage DIETARY_SUPPLEMENT

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

Also known as: Placebo beverage

Nitrate free beverage

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Information consenting out-patients with a previous physician diagnosis of COPD
• Clinically stable
• Ambulatory

You may not qualify if:

• Subjects who required supplemental oxygen for exercise
• Subjects with pulmonary hypertension and angina
• Intolerant to beetroot
• Insulin dependent diabetes
• Thyroid disease

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• University College Dublin: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Conor P Kerley, BSc

  University College Dublin

  STUDY DIRECTOR

• Liam J Cormican, MD

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 28, 2014
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 5, 2014

Record last verified: 2014-06