Inorganic Nitrate and OSA

NCT ID: NCT03930563

Last Updated: 2021-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2020-03-06

Brief Summary

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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

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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

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Pre-beetroot juice supplementation

Intervention Type DIETARY_SUPPLEMENT

Before administering beetroot juice to subjects.

Post-beetroot juice supplementation

Intervention Type DIETARY_SUPPLEMENT

After administering beetroot juice to subjects.

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.

Group Type EXPERIMENTAL

Pre-beetroot juice supplementation

Intervention Type DIETARY_SUPPLEMENT

Before administering beetroot juice to subjects.

Post-beetroot juice supplementation

Intervention Type DIETARY_SUPPLEMENT

After administering beetroot juice to subjects.

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.

Group Type ACTIVE_COMPARATOR

Pre-beetroot juice supplementation

Intervention Type DIETARY_SUPPLEMENT

Before administering beetroot juice to subjects.

Post-beetroot juice supplementation

Intervention Type DIETARY_SUPPLEMENT

After administering beetroot juice to subjects.

Interventions

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Pre-beetroot juice supplementation

Before administering beetroot juice to subjects.

Intervention Type DIETARY_SUPPLEMENT

Post-beetroot juice supplementation

After administering beetroot juice to subjects.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Darren P Casey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Darren P Casey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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Medical Education Building

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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201812786

Identifier Type: -

Identifier Source: org_study_id

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