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

Royal College of Surgeons, Ireland

Status: Completed

Conditions: Obstructive Sleep Apnoea Syndrome

Treatments: Dietary Supplement: Dietary nitrate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02515071

Chronic NO3- in OSAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

Nitrate rich beetroot juice

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary nitrate

Nitrate depleted placebo beetroot juice

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo