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OpenTrials
Completed

NCT Number: NCT02521532

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory & Sleep Diagnostics Department, Connolly Hospital

Dublin, D15, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary nitrate

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Change in incremental shuttle walk test distance

    Time frame: Day 1, day 15 and day 29

Secondary outcomes

  1. Change in plasma nitrate

    Time frame: Day 1, day 15 and day 29

    Assessed by chemiluminescence

  2. Change in ambulatory blood pressure

    Time frame: Day 1, day 15 and day 29

  3. Change in quality of life

    Time frame: Day 1, day 15 and day 29

    Quality of Life will be assessed with the Clinical COPD Questionnaire

  4. Change in forced expiratory volume

    Time frame: Day 1, day 15 and day 29

    Assessed by spirometry

  5. Change in inflammatory markers

    Time frame: Day 1, day 15 and day 29

    Assessed by C-reactive protein

  6. Change in forced vital capacity

    Time frame: Day 1, day 15 and day 29

    Assessed by spirometry

  7. Change in plasma nitrate and nitrite

    Time frame: Day 1, day 15 and day 29

    Assessed by chemiluminescence

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Collaborators

  • Connolly Hospital Blanchardstown
  • University College Dublin

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2015
Registry last updated
Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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