Inorganic Nitrate and OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930563
• Other study ID #: 201812786
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: March 6, 2020

Study information

• Verified date: April 2021
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Beetroot juice also improves blood flow thus, the investigators will also measure blood flow to the carotid chemoreceptors.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Dietary Supplement:
• Pre-beetroot juice supplementation
Before administering beetroot juice to subjects.
• Post-beetroot juice supplementation
After administering beetroot juice to subjects.

Locations

Country	Name	City	State
United States	Medical Education Building	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in peripheral chemoreflex sensitivity	The ventilatory response to acute hypoxia will be measured via pneumotachometer.	Before and after consuming all supplements (within three hours)
Secondary	Changes in common carotid artery blood flow	Blood flow through the common carotid artery before and during hypoxia measured via Doppler ultrasound	Before and after consuming all supplements (within three hours)