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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Dietary nitrate

• Registration Number: NCT02521532
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-07
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-10-22
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nitrate depleted placebo beetroot juice	Placebo	Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
Nitrate rich beetroot juice	Dietary nitrate	Concentrated, beetroot juice is a rich source of dietary nitrate.

Primary Outcome Measures

Name	Time	Method
Change in incremental shuttle walk test distance	Day 1, day 15 and day 29

Secondary Outcome Measures

Name	Time	Method
Change in plasma nitrate	Day 1, day 15 and day 29	Assessed by chemiluminescence
Change in forced expiratory volume	Day 1, day 15 and day 29	Assessed by spirometry
Change in forced vital capacity	Day 1, day 15 and day 29	Assessed by spirometry
Change in ambulatory blood pressure	Day 1, day 15 and day 29
Change in quality of life	Day 1, day 15 and day 29	Quality of Life will be assessed with the Clinical COPD Questionnaire
Change in plasma nitrate and nitrite	Day 1, day 15 and day 29	Assessed by chemiluminescence
Change in inflammatory markers	Day 1, day 15 and day 29	Assessed by C-reactive protein

Trial Locations

Locations (1)

Respiratory & Sleep Diagnostics Department, Connolly Hospital; 🇮🇪 Dublin, Ireland