Obstructive Sleep ApneaNCT03930563
Inorganic Nitrate and OSA
A study testing Pre-beetroot juice supplementation and Post-beetroot juice supplementation in people with Obstructive Sleep Apnea, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Pre-beetroot juice supplementation and Post-beetroot juice supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 6 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OSA group: patients recently diagnosed with mild-to-moderate OSA
- Control group: healthy individuals
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Beetroot Juice Supplementation and Peripheral Chemoreflex Sensitivity in Patients With Obstructive Sleep Apnea
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Pre-beetroot juice supplementation, Post-beetroot juice supplementation
- Keywords
- inorganic nitrate, blood flow, Peripheral chemoreflex, Common carotid artery
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-beetroot juice supplementationDietary supplement
Before administering beetroot juice to subjects.
Post-beetroot juice supplementationDietary supplement
After administering beetroot juice to subjects.
| Study group | Role | What they receive |
|---|---|---|
| Beetroot Juice Low | Experimental | 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. Receives: Dietary Supplement: Pre-beetroot juice supplementation; Dietary Supplement: Post-beetroot juice supplementation |
| Beetroot Juice High | Experimental | 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. Receives: Dietary Supplement: Pre-beetroot juice supplementation; Dietary Supplement: Post-beetroot juice supplementation |
| Beetroot Juice Placebo | Active comparator | 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. Receives: Dietary Supplement: Pre-beetroot juice supplementation; Dietary Supplement: Post-beetroot juice supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peripheral chemoreflex sensitivity
The ventilatory response to acute hypoxia will be measured via pneumotachometer.
Measured: Before and after consuming all supplements (within three hours)
Secondary outcomes (1)
Changes in common carotid artery blood flow
Blood flow through the common carotid artery before and during hypoxia measured via Doppler ultrasound
Measured: Before and after consuming all supplements (within three hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start12 Jun 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren P Casey, University of Iowa
- Investigators
- Darren P Casey, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930563
- Sponsor's protocol ID
- 201812786
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Beetroot Juice Supplementation and Peripheral Chemoreflex Sensitivity in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03930563
- Acronym / sponsor ID
- 201812786
- Conditions
- Obstructive Sleep Apnea
- Keywords
- inorganic nitrate, blood flow, Peripheral chemoreflex, Common carotid artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Beetroot Juice Low | Experimental | Dietary Supplement: Pre-beetroot juice supplementation, Dietary Supplement: Post-beetroot juice supplementationSubjects 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. |
| Beetroot Juice High | Experimental | Dietary Supplement: Pre-beetroot juice supplementation, Dietary Supplement: Post-beetroot juice supplementationSubjects 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. |
| Beetroot Juice Placebo | Active comparator | Dietary Supplement: Pre-beetroot juice supplementation, Dietary Supplement: Post-beetroot juice supplementationSubjects 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OSA group: patients recently diagnosed with mild-to-moderate OSA
- Control group: healthy individuals
Key exclusion criteria (10 listed)
- Diagnosis of heart disease
- Diagnosis of diabetes
- Diagnosis of any autonomic disorders
- Diagnosis of kidney disease
- Diagnosis of central sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-beetroot juice supplementationBefore administering beetroot juice to subjects. | Dietary supplement | Beetroot Juice High, Beetroot Juice Low, Beetroot Juice Placebo |
| Post-beetroot juice supplementationAfter administering beetroot juice to subjects. | Dietary supplement | Beetroot Juice High, Beetroot Juice Low, Beetroot Juice Placebo |
Primary outcome
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.
1 secondary outcome
Changes in common carotid artery blood flow
Time frame: Before and after consuming all supplements (within three hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren P Casey, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-beetroot juice supplementation and Post-beetroot juice supplementation in people with Obstructive Sleep Apnea, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in peripheral chemoreflex sensitivity (time frame: Before and after consuming all supplements (within three hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.