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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

Tracking Information
First Submitted Date  ICMJE April 19, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE June 12, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03930563 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inorganic Nitrate and OSA
Official Title  ICMJE Acute Beetroot Juice Supplementation and Peripheral Chemoreflex Sensitivity in Patients With Obstructive Sleep Apnea
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • Dietary Supplement: Pre-beetroot juice supplementation
    Before administering beetroot juice to subjects.
  • Dietary Supplement: Post-beetroot juice supplementation
    After administering beetroot juice to subjects.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Dietary Supplement: Pre-beetroot juice supplementation
    • Dietary Supplement: Post-beetroot juice supplementation
  • 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.
    Interventions:
    • Dietary Supplement: Pre-beetroot juice supplementation
    • Dietary Supplement: Post-beetroot juice supplementation
  • 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.
    Interventions:
    • Dietary Supplement: Pre-beetroot juice supplementation
    • Dietary Supplement: Post-beetroot juice supplementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Darren P Casey, PhD 319-384-1009 darren-casey@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930563
Other Study ID Numbers  ICMJE 201812786
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Darren P Casey, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Darren P Casey, PhD University of Iowa
PRS Account University of Iowa
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP