NCT02515071

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnoea Syndrome

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-08-04
• Last updated: 2015-10-23

Locations

1 site across 1 country: Ireland