Back to resultsInorganic Nitrate and OSA
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-beetroot juice supplementation
Post-beetroot juice supplementation
Sponsored by
About this trial
This is an interventional basic science trial for Obstructive Sleep Apnea focused on measuring inorganic nitrate, blood flow, Peripheral chemoreflex, Common carotid artery
Eligibility 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
Sites / Locations
- Medical Education Building
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Beetroot Juice Low
Beetroot Juice High
Beetroot Juice Placebo
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Changes in peripheral chemoreflex sensitivity
The ventilatory response to acute hypoxia will be measured via pneumotachometer.
Secondary Outcome Measures
Changes in common carotid artery blood flow
Blood flow through the common carotid artery before and during hypoxia measured via Doppler ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03930563
Brief Title
Inorganic Nitrate and OSA
Official Title
Acute Beetroot Juice Supplementation and Peripheral Chemoreflex Sensitivity in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
inorganic nitrate, blood flow, Peripheral chemoreflex, Common carotid artery
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beetroot Juice Low
Arm Type
Experimental
Arm Description
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.
Arm Title
Beetroot Juice High
Arm Type
Experimental
Arm Description
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.
Arm Title
Beetroot Juice Placebo
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pre-beetroot juice supplementation
Intervention Description
Before administering beetroot juice to subjects.
Intervention Type
Dietary Supplement
Intervention Name(s)
Post-beetroot juice supplementation
Intervention Description
After administering beetroot juice to subjects.
Primary Outcome Measure Information:
Title
Changes in peripheral chemoreflex sensitivity
Description
The ventilatory response to acute hypoxia will be measured via pneumotachometer.
Time Frame
Before and after consuming all supplements (within three hours)
Secondary Outcome Measure Information:
Title
Changes in common carotid artery blood flow
Description
Blood flow through the common carotid artery before and during hypoxia measured via Doppler ultrasound
Time Frame
Before and after consuming all supplements (within three hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren P Casey, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Education Building
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Inorganic Nitrate and OSA
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