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

Obstructive Sleep Apnoea Syndrome Clinical Trial

Official title:

Dietary Nitrate for OSAS: a Randomized, Placebo-controlled, Crossover Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515071
• Other study ID #: Chronic NO3- in OSAS
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: October 22, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: August 2015
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obstructive Sleep Apnoea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Ireland	Connolly Hospital, Blanchardstown	Dublin

Sponsors (3)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	Connolly Hospital Blanchardstown, University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in ambulatory nocturnal blood pressure	Comparison of the change after nitrate-rich beetroot juice compared to placebo.	Day 1, day 15, day 29	No
Secondary	Difference in 24h blood pressure	Comparison of the change after nitrate-rich beetroot juice compared to placebo.	Day 1, day 15, day 29	Yes
Secondary	Difference in plasma nitrate and nitrite	Comparison of the change after nitrate-rich beetroot juice compared to placebo.	Day 1, day 15, day 29	No
Secondary	Difference in fasting glucose	Comparison of the change after nitrate-rich beetroot juice compared to placebo.	Day 1, day 15, day 29	No
Secondary	Difference in OSAS symptomatology	Comparison of the change after nitrate-rich beetroot juice compared to placebo.	Day 1, day 15, day 29	No
Secondary	Difference in 2h post OGT glucose	Comparison of the change after nitrate-rich beetroot juice compared to placebo.	Day 1, day 15, day 29	No
Secondary	Difference in overnight oximetry	Comparison of the change after nitrate-rich beetroot juice compared to placebo.	Day 1, day 15, day 29	No
Secondary	Difference in exhaled nitric oxide	Comparison of the change after nitrate-rich beetroot juice compared to placebo.	Day 1, day 15, day 29	No
Secondary	Difference in vigilance scores derived from the Conner's Continuous Performance Test.	Comparison of the change after nitrate-rich beetroot juice compared to placebo.	Day 1, day 15, day 29	No