Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 527 for:    NITRATE ION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02515071
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : October 23, 2015
Sponsor:
Collaborators:
University College Dublin
Connolly Hospital Blanchardstown
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnoea Syndrome Dietary Supplement: Dietary nitrate Dietary Supplement: Placebo Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Dietary Nitrate for OSAS: a Randomized, Placebo-controlled, Crossover Trial.
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Nitrate rich beetroot juice
Concentrated, beetroot juice is a rich source of dietary nitrate.
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.
Other Name: Beetroot juice

Placebo Comparator: Nitrate depleted placebo beetroot juice
Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.
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.
Other Name: Nitrate depleted beetroot juice




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515071


Locations
Layout table for location information
Ireland
Connolly Hospital, Blanchardstown
Dublin, Ireland, D15
Sponsors and Collaborators
Royal College of Surgeons, Ireland
University College Dublin
Connolly Hospital Blanchardstown
Investigators
Layout table for investigator information
Principal Investigator: Liam Cormican, MD Connolly Hospital

Layout table for additonal information
Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT02515071     History of Changes
Other Study ID Numbers: Chronic NO3- in OSAS
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases