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

Royal College of Surgeons, Ireland

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Dietary nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02521532

Chronic NO3- in COPD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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8 participants in 2 patient groups, including a placebo group

Nitrate rich beetroot juice

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary nitrate

Nitrate depleted placebo beetroot juice

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo