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Inorganic Nitrate and OSA

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ClinicalTrials.gov Identifier: NCT03930563
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Darren P Casey, University of Iowa

Brief Summary:
The main purpose of this study is to determine if acute beetroot juice supplementation reduces peripheral chemoreflex sensitivity in patients with obstructive sleep apnea. All subjects will consume low-dose (BRL), higher-dose (BRH), and placebo (BRP) beetroot juice randomly on three independent study visits. Beetroot juice also improves blood flow thus, the investigators will also measure blood flow to the carotid chemoreceptors.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Dietary Supplement: Pre-beetroot juice supplementation Dietary Supplement: Post-beetroot juice supplementation Not Applicable

Detailed Description:
Four-weeks of daily beetroot juice supplementation reduces peripheral chemoreflex sensitivity in healthy older adults who have 'normal' responses to acute hypoxia. Patients with obstructive sleep apnea have exaggerated peripheral chemoreflex sensitivity. It remains unknown if beetroot juice supplementation reduces peripheral chemoreflex sensitivity in patients with obstructive sleep apnea. Additionally, increasing blood flow to the peripheral chemoreceptors reduces sensitivity. Given that beetroot juice improves blood flow, the investigators will also measure common carotid artery blood flow at rest and during hypoxia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Acute Beetroot Juice Supplementation and Peripheral Chemoreflex Sensitivity in Patients With Obstructive Sleep Apnea
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Beetroot Juice Low
Subjects will consume beetroot juice containing 250mg inorganic nitrate and 20mg nitrite dissolved in 120ml bottled water. Peripheral chemoreflex sensitivity as well as common carotid artery blood flow will be assessed before and after supplementation.
Dietary Supplement: Pre-beetroot juice supplementation
Before administering beetroot juice to subjects.

Dietary Supplement: Post-beetroot juice supplementation
After administering beetroot juice to subjects.

Experimental: Beetroot Juice High
Subjects will consume beetroot juice containing 500mg inorganic nitrate and 40mg nitrite dissolved in 120ml bottled water. Peripheral chemoreflex sensitivity as well as common carotid artery blood flow will be assessed before and after supplementation.
Dietary Supplement: Pre-beetroot juice supplementation
Before administering beetroot juice to subjects.

Dietary Supplement: Post-beetroot juice supplementation
After administering beetroot juice to subjects.

Active Comparator: Beetroot Juice Placebo
Subjects will consume beetroot juice devoid of inorganic nitrate and nitrite dissolved in 120ml bottled water. Peripheral chemoreflex sensitivity as well as common carotid artery blood flow will be assessed before and after supplementation.
Dietary Supplement: Pre-beetroot juice supplementation
Before administering beetroot juice to subjects.

Dietary Supplement: Post-beetroot juice supplementation
After administering beetroot juice to subjects.




Primary Outcome Measures :
  1. Changes in peripheral chemoreflex sensitivity [ Time Frame: Before and after consuming all supplements (within three hours) ]
    The ventilatory response to acute hypoxia will be measured via pneumotachometer.


Secondary Outcome Measures :
  1. Changes in common carotid artery blood flow [ Time Frame: Before and after consuming all supplements (within three hours) ]
    Blood flow through the common carotid artery before and during hypoxia measured via Doppler ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • OSA group: patients recently diagnosed with mild-to-moderate OSA
  • Control group: healthy individuals

Exclusion Criteria:

  • Diagnosis of heart disease
  • Diagnosis of diabetes
  • Diagnosis of any autonomic disorders
  • Diagnosis of kidney disease
  • Diagnosis of central sleep apnea
  • Regular physical activity exceeding 30 minutes 3 days/week
  • A body mass index ≥40 kg/m2
  • Current or former use of a continuous positive airway pressure machine
  • Current tobacco use
  • Currently prescribed hormone replacement therapy

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): NCT03930563


Contacts
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Contact: Darren P Casey, PhD 319-384-1009 darren-casey@uiowa.edu

Locations
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United States, Iowa
Medical Education Building Recruiting
Iowa City, Iowa, United States, 52242
Contact: Darren P Casey, Ph.D.    319-334-1009    darren-casey@uiowa.edu   
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Darren P Casey, PhD University of Iowa

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Responsible Party: Darren P Casey, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03930563     History of Changes
Other Study ID Numbers: 201812786
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Darren P Casey, University of Iowa:
inorganic nitrate
blood flow
Peripheral chemoreflex
Common carotid artery
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases