Clinical trial NCT02521532: A 2 Week, Crossover Trial of Dietary Nitrate in Chronic Obstructive Pulmonary Disease
Official title: Dietary Nitrate for COPD: a 14d, Randomized, Placebo-controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: University College Dublin
name: Connolly Hospital Blanchardstown
First posted: 2015-08-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in incremental shuttle walk test distance
timeFrame: Day 1, day 15 and day 29
Secondary outcomes:
measure: Change in plasma nitrate
timeFrame: Day 1, day 15 and day 29
measure: Change in ambulatory blood pressure
timeFrame: Day 1, day 15 and day 29
measure: Change in quality of life
timeFrame: Day 1, day 15 and day 29
measure: Change in forced expiratory volume
timeFrame: Day 1, day 15 and day 29
measure: Change in inflammatory markers
timeFrame: Day 1, day 15 and day 29
measure: Change in forced vital capacity
timeFrame: Day 1, day 15 and day 29
measure: Change in plasma nitrate and nitrite
timeFrame: Day 1, day 15 and day 29
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Respiratory & Sleep Diagnostics Department, Connolly Hospital
Study officials:
affiliation: Respiratory & Sleep Diagnostics Department, Connolly Hospital, Dublin 15, Ireland
name: Liam Cormican, MD
role: PRINCIPAL_INVESTIGATOR
References: