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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Dietary supplement: Dietary nitrate; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D15
    • Respiratory & Sleep Diagnostics Department, Connolly Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitrate rich beetroot juice; Concentrated, beetroot juice is a rich source of dietary nitrate.	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.; Other Names: Beetroot juice
Placebo Comparator: Nitrate depleted placebo beetroot juice; Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.	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.; Other Names: Nitrate depleted beetroot juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in incremental shuttle walk test distance	Day 1, day 15 and day 29

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Collaborators: University College Dublin; Connolly Hospital Blanchardstown
• Investigators: Principal Investigator: Liam Cormican, MD, Respiratory & Sleep Diagnostics Department, Connolly Hospital, Dublin 15, Ireland

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): October 23, 2015
• Last Update Submitted That Met QC Criteria: October 22, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Chronic NO3- in COPD