NCT02521532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 23, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

January 7, 2015

Last Update Submit

October 22, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Change in incremental shuttle walk test distance

    Day 1, day 15 and day 29

Secondary Outcomes (7)

  • Change in plasma nitrate

    Day 1, day 15 and day 29

  • Change in ambulatory blood pressure

    Day 1, day 15 and day 29

  • Change in quality of life

    Day 1, day 15 and day 29

  • Change in forced expiratory volume

    Day 1, day 15 and day 29

  • Change in inflammatory markers

    Day 1, day 15 and day 29

  • +2 more secondary outcomes

Study Arms (2)

Nitrate rich beetroot juice

EXPERIMENTAL

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

Dietary Supplement: Dietary nitrate

Nitrate depleted placebo beetroot juice

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Dietary nitrateDIETARY_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.

Also known as: Beetroot juice
Nitrate rich beetroot juice
PlaceboDIETARY_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.

Also known as: Nitrate depleted beetroot juice
Nitrate depleted placebo beetroot juice

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically stable,
  • Diagnosed with COPD
  • Ambulatory out-patients

You may not qualify if:

  • Long term oxygen therapy
  • Pulmonary hypertension
  • Active cardiovascular disease
  • Active skeletal conditions
  • Taking vasodilators
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory & Sleep Diagnostics Department, Connolly Hospital

Dublin, D15, Ireland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Liam Cormican, MD

    Respiratory & Sleep Diagnostics Department, Connolly Hospital, Dublin 15, Ireland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

August 13, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 23, 2015

Record last verified: 2015-08

Locations

IE(1)