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OpenTrials
Completed

NCT Number: NCT02515071

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connolly Hospital, Blanchardstown

Dublin, D15, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary nitrate

Dietary Supplement

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.

Other names: Beetroot juice

Placebo

Dietary Supplement

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.

Other names: Nitrate depleted beetroot juice

Primary outcomes

  1. Difference in ambulatory nocturnal blood pressure

    Time frame: Day 1, day 15, day 29

    Comparison of the change after nitrate-rich beetroot juice compared to placebo.

Secondary outcomes

  1. Difference in 24h blood pressure

    Time frame: Day 1, day 15, day 29

    Comparison of the change after nitrate-rich beetroot juice compared to placebo.

  2. Difference in plasma nitrate and nitrite

    Time frame: Day 1, day 15, day 29

    Comparison of the change after nitrate-rich beetroot juice compared to placebo.

  3. Difference in fasting glucose

    Time frame: Day 1, day 15, day 29

    Comparison of the change after nitrate-rich beetroot juice compared to placebo.

  4. Difference in OSAS symptomatology

    Time frame: Day 1, day 15, day 29

    Comparison of the change after nitrate-rich beetroot juice compared to placebo.

  5. Difference in 2h post OGT glucose

    Time frame: Day 1, day 15, day 29

    Comparison of the change after nitrate-rich beetroot juice compared to placebo.

  6. Difference in overnight oximetry

    Time frame: Day 1, day 15, day 29

    Comparison of the change after nitrate-rich beetroot juice compared to placebo.

  7. Difference in exhaled nitric oxide

    Time frame: Day 1, day 15, day 29

    Comparison of the change after nitrate-rich beetroot juice compared to placebo.

  8. Difference in vigilance scores derived from the Conner's Continuous Performance Test.

    Time frame: Day 1, day 15, day 29

    Comparison of the change after nitrate-rich beetroot juice compared to placebo.

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Collaborators

  • Connolly Hospital Blanchardstown
  • University College Dublin

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 4, 2015
Registry last updated
Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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