Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function

Coronary Artery Disease Clinical Trial

Official title:

Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04920799
• Other study ID #: IRB202100040
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: Demetra Christou, PhD
• Phone: 352-294-1746
• Email: ddchristou[@]hhp.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Dietary Supplement:
• Nitrate rich beetroot juice
Participants will drink nitrate rich beetroot juice (2.4 floz ; Beet It Sport Nitrate 400 concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks.
• Nitrate depleted beetroot juice
Participants will drink nitrate depleted beetroot juice (2.4 floz ; Beet It placebo concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks.

Locations

Country	Name	City	State
United States	Integrative Cardiovascular Physiology Laboratory, University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endothelial function	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.	Baseline up to following 2 weeks of experimental condition
Primary	Change in inspiratory muscle function	Inspiratory muscle function including strength, power and endurance will be assessed using the POWERbreathe KH2 device	Baseline up to following 2 weeks of experimental condition
Secondary	Change in microvascular function	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.	Baseline up to following 2 weeks of experimental condition
Secondary	Change in central arterial stiffness	The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity.	Baseline up to following 2 weeks of experimental condition
Secondary	Change in central arterial hemodynamics	The SphygmoCor XCEL device will be used to obtain central pulse wave analysis.	Baseline up to following 2 weeks of experimental condition
Secondary	Change in functional capacity	Using the Duke Activity Status Index we will assess participants' ability to perform daily activities.	Baseline up to following 2 weeks of experimental condition