NCT02521532

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

Dietary Nitrate for COPD: a 14d, Randomized, Placebo-controlled, Crossover Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-08-13
• Last updated: 2015-10-23

Locations

1 site across 1 country: Ireland