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

NCT02515071 | Completed

• 1 other identifier: Chronic NO3- in OSAS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnoea Syndrome

Outcome Measures

Primary Outcomes (1)

• Difference in ambulatory nocturnal blood pressure

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

  Day 1, day 15, day 29

Secondary Outcomes (8)

• Difference in 24h blood pressure

  Day 1, day 15, day 29

• Difference in plasma nitrate and nitrite

  Day 1, day 15, day 29

• Difference in fasting glucose

  Day 1, day 15, day 29

• Difference in OSAS symptomatology

  Day 1, day 15, day 29

• Difference in 2h post OGT glucose

  Day 1, day 15, day 29

Study Arms (2)

Nitrate rich beetroot juice

EXPERIMENTAL

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

Dietary Supplement: Dietary nitrate

Nitrate depleted placebo beetroot juice

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

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.

Also known as: Beetroot juice

Nitrate rich 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.

Also known as: Nitrate depleted beetroot juice

Nitrate depleted placebo beetroot juice

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically stable,
• Untreated OSAS out-patients

You may not qualify if:

• Using continuous positive airways pressure therapy
• Pulmonary hypertension
• Active CVD
• Active musculo-skeletal conditions
• Taking vasodilators
• Diabetes mellitus

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• University College Dublin: collaborator
• Connolly Hospital Blanchardstown: collaborator

Study Sites (1)

Connolly Hospital, Blanchardstown

Dublin, D15, Ireland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Liam Cormican, MD

  Connolly Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: August 4, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 23, 2015

Record last verified: 2015-08

Locations

IE (1)