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

NCT ID: NCT02521532

Last Updated: 2015-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Nitrate rich beetroot juice

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

Group Type: EXPERIMENTAL

Dietary nitrate

Intervention Type: DIETARY_SUPPLEMENT

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.

Nitrate depleted placebo beetroot juice

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Beetroot juice; Nitrate depleted beetroot juice

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: lead

University College Dublin

OTHER

Sponsor Role: collaborator

Connolly Hospital Blanchardstown

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liam Cormican, MD

Role: PRINCIPAL_INVESTIGATOR

Respiratory & Sleep Diagnostics Department, Connolly Hospital, Dublin 15, Ireland

Locations

Respiratory & Sleep Diagnostics Department, Connolly Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

Chronic NO3- in COPD

Identifier Type: -

Identifier Source: org_study_id