Chronic Obstructive Pulmonary Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDietary 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_SUPPLEMENTPlacebo
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.
Sponsors
University College Dublin
Connolly Hospital Blanchardstown
Royal College of Surgeons, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in incremental shuttle walk test distance | Day 1, day 15 and day 29 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ambulatory blood pressure | Day 1, day 15 and day 29 | — |
| Change in plasma nitrate | Day 1, day 15 and day 29 | Assessed by chemiluminescence |
| 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 forced expiratory volume | Day 1, day 15 and day 29 | Assessed by spirometry |
| Change in inflammatory markers | Day 1, day 15 and day 29 | Assessed by C-reactive protein |
| Change in forced vital capacity | Day 1, day 15 and day 29 | Assessed by spirometry |
| Change in plasma nitrate and nitrite | Day 1, day 15 and day 29 | Assessed by chemiluminescence |
Countries
Ireland
Outcome results
None listed