A 2 Week, Crossover Trial of Dietary Nitrate in Obstructive Sleep Apnoea Syndrome (OSAS).
- Conditions
- Obstructive Sleep Apnoea Syndrome
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Dietary nitrate
- Registration Number
- NCT02515071
- Lead Sponsor
- Royal College of Surgeons, Ireland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Clinically stable,
- Untreated OSAS out-patients
- Using continuous positive airways pressure therapy
- Pulmonary hypertension
- Active CVD
- Active musculo-skeletal conditions
- Taking vasodilators
- Diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Nitrate depleted placebo beetroot juice Placebo Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content. Nitrate rich beetroot juice Dietary nitrate Concentrated, beetroot juice is a rich source of dietary nitrate.
- Primary Outcome Measures
Name Time Method Difference in ambulatory nocturnal blood pressure Day 1, day 15, day 29 Comparison of the change after nitrate-rich beetroot juice compared to placebo.
- Secondary Outcome Measures
Name Time Method Difference in OSAS symptomatology Day 1, day 15, day 29 Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in exhaled nitric oxide Day 1, day 15, day 29 Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in 2h post OGT glucose Day 1, day 15, day 29 Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in vigilance scores derived from the Conner's Continuous Performance Test. Day 1, day 15, day 29 Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in 24h blood pressure Day 1, day 15, day 29 Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in plasma nitrate and nitrite Day 1, day 15, day 29 Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in fasting glucose Day 1, day 15, day 29 Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Difference in overnight oximetry Day 1, day 15, day 29 Comparison of the change after nitrate-rich beetroot juice compared to placebo.
Trial Locations
- Locations (1)
Connolly Hospital, Blanchardstown
🇮🇪Dublin, Ireland