Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT04920799
• Lead Sponsor: University of Florida

Brief Summary

Older adults with coronary artery disease (CAD) have impaired vascular and inspiratory muscle function. The objective of this study is to examine the effect of beet juice supplementation on vascular and inspiratory muscle function in older adults with CAD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-10
• Study Start: 2021-11-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Adults with coronary artery disease (CAD) based on an angiogram >50% stenosis in any major epicardial vessel or history of myocardial infarction or history of coronary revascularization.
• Considered to have stable CAD on optimal medical therapy
• 60 to 85 years of age
• Men and women (women must be postmenopausal either natural or surgical)
• Able to give consent

Exclusion Criteria

• Ejection fraction <50%, unstable angina, recent myocardial infarction within 6 months
• Coronary revascularization, including percutaneous coronary intervention and coronary artery bypass graft or thoracic surgery within 6 months.
• Stroke, obstructive pulmonary disease, hepatitis B, C, HIV, seizures, or other relevant on-going or recurrent illness
• Individuals that have participated in respiratory training within the last 12 months or cardiac rehabilitation within the last 6 months
• Uncontrolled hypertension
• Use of tobacco products including smoking traditional or e-cigarettes
• Use of hormone replacement therapy in women or men (e.g., estrogen, progesterone or testosterone)
• Regular aerobic exercise training
• Unwilling to stop using mouthwash at least 1 week before the start of the study and during study participation
• Unwilling to remain weight stable during study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in inspiratory muscle function	Baseline up to following 2 weeks of experimental condition	Inspiratory muscle function including strength, power and endurance will be assessed using the POWERbreathe KH2 device
Change in endothelial function	Baseline up to following 2 weeks of experimental condition	Endothelial function will be determined using brachial artery flow-mediated dilation via high resolution duplex ultrasonography. Reactive hyperemia will be produced by inflating a forearm cuff to \~250 mmHg for 5 minutes followed by rapid deflation.

Secondary Outcome Measures

Name	Time	Method
Change in microvascular function	Baseline up to following 2 weeks of experimental condition	Microvascular function will be assessed using the forearm blood flow response to submaximal handgrip exercise. Brachial artery blood flow and diameter will be assessed using ultrasound.
Change in central arterial stiffness	Baseline up to following 2 weeks of experimental condition	The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity.
Change in central arterial hemodynamics	Baseline up to following 2 weeks of experimental condition	The SphygmoCor XCEL device will be used to obtain central pulse wave analysis.
Change in functional capacity	Baseline up to following 2 weeks of experimental condition	Using the Duke Activity Status Index we will assess participants' ability to perform daily activities.

Trial Locations

Locations (1)

Integrative Cardiovascular Physiology Laboratory, University of Florida; 🇺🇸 Gainesville, Florida, United States