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OpenTrials
Completed

NCT Number: NCT03930563

Inorganic Nitrate and OSA

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Education Building

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-beetroot juice supplementation

Dietary Supplement

Before administering beetroot juice to subjects.

Post-beetroot juice supplementation

Dietary Supplement

After administering beetroot juice to subjects.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Acute Beetroot Juice Supplementation and Peripheral Chemoreflex Sensitivity in Patients With Obstructive Sleep Apnea

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2019
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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