search
Back to results

A 2 Week, Crossover Trial of Dietary Nitrate in Obstructive Sleep Apnoea Syndrome (OSAS).

Primary Purpose

Obstructive Sleep Apnoea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Dietary nitrate
Placebo
Sponsored by
Royal College of Surgeons, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnoea Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically stable,
  • Untreated OSAS out-patients

Exclusion Criteria:

  • Using continuous positive airways pressure therapy
  • Pulmonary hypertension
  • Active CVD
  • Active musculo-skeletal conditions
  • Taking vasodilators
  • Diabetes mellitus

Sites / Locations

  • Connolly Hospital, Blanchardstown

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nitrate rich beetroot juice

Nitrate depleted placebo beetroot juice

Arm Description

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

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

Outcomes

Primary Outcome Measures

Difference in ambulatory nocturnal blood pressure
Comparison of the change after nitrate-rich beetroot juice compared to placebo.

Secondary Outcome Measures

Difference in 24h blood pressure
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in plasma nitrate and nitrite
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in fasting glucose
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in OSAS symptomatology
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in 2h post OGT glucose
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in overnight oximetry
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in exhaled nitric oxide
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in vigilance scores derived from the Conner's Continuous Performance Test.
Comparison of the change after nitrate-rich beetroot juice compared to placebo.

Full Information

First Posted
January 7, 2015
Last Updated
October 22, 2015
Sponsor
Royal College of Surgeons, Ireland
Collaborators
University College Dublin, Connolly Hospital Blanchardstown
search

1. Study Identification

Unique Protocol Identification Number
NCT02515071
Brief Title
A 2 Week, Crossover Trial of Dietary Nitrate in Obstructive Sleep Apnoea Syndrome (OSAS).
Official Title
Dietary Nitrate for OSAS: a Randomized, Placebo-controlled, Crossover Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal College of Surgeons, Ireland
Collaborators
University College Dublin, Connolly Hospital Blanchardstown

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.
Detailed Description
Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported. The investigators hypothesize that chronic nitrate consumption might decrease blood pressure and dysglycaemia and improve vigilance compared to a placebo beetroot juice. This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics, questionnaires, vigilance 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitrate rich beetroot juice
Arm Type
Experimental
Arm Description
Concentrated, beetroot juice is a rich source of dietary nitrate.
Arm Title
Nitrate depleted placebo beetroot juice
Arm Type
Placebo Comparator
Arm Description
Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary nitrate
Other Intervention Name(s)
Beetroot juice
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Nitrate depleted beetroot juice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in ambulatory nocturnal blood pressure
Description
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Time Frame
Day 1, day 15, day 29
Secondary Outcome Measure Information:
Title
Difference in 24h blood pressure
Description
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Time Frame
Day 1, day 15, day 29
Title
Difference in plasma nitrate and nitrite
Description
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Time Frame
Day 1, day 15, day 29
Title
Difference in fasting glucose
Description
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Time Frame
Day 1, day 15, day 29
Title
Difference in OSAS symptomatology
Description
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Time Frame
Day 1, day 15, day 29
Title
Difference in 2h post OGT glucose
Description
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Time Frame
Day 1, day 15, day 29
Title
Difference in overnight oximetry
Description
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Time Frame
Day 1, day 15, day 29
Title
Difference in exhaled nitric oxide
Description
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Time Frame
Day 1, day 15, day 29
Title
Difference in vigilance scores derived from the Conner's Continuous Performance Test.
Description
Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Time Frame
Day 1, day 15, day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically stable, Untreated OSAS out-patients Exclusion Criteria: Using continuous positive airways pressure therapy Pulmonary hypertension Active CVD Active musculo-skeletal conditions Taking vasodilators Diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liam Cormican, MD
Organizational Affiliation
Connolly Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connolly Hospital, Blanchardstown
City
Dublin
ZIP/Postal Code
D15
Country
Ireland

12. IPD Sharing Statement

Learn more about this trial

A 2 Week, Crossover Trial of Dietary Nitrate in Obstructive Sleep Apnoea Syndrome (OSAS).

We'll reach out to this number within 24 hrs