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Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nitrate rich beetroot juice
Nitrate depleted beetroot juice
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coronary Artery Disease

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Integrative Cardiovascular Physiology Laboratory, University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nitrate rich beetroot juice

Nitrate depleted beetroot juice

Arm Description

Outcomes

Primary Outcome Measures

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.
Change in inspiratory muscle function
Inspiratory muscle function including strength, power and endurance will be assessed using the POWERbreathe KH2 device

Secondary Outcome Measures

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.
Change in central arterial stiffness
The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity.
Change in central arterial hemodynamics
The SphygmoCor XCEL device will be used to obtain central pulse wave analysis.
Change in functional capacity
Using the Duke Activity Status Index we will assess participants' ability to perform daily activities.

Full Information

First Posted
May 27, 2021
Last Updated
March 20, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04920799
Brief Title
Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function
Official Title
Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nitrate rich beetroot juice
Arm Type
Active Comparator
Arm Title
Nitrate depleted beetroot juice
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Nitrate rich beetroot juice
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nitrate depleted beetroot juice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in endothelial function
Description
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.
Time Frame
Baseline up to following 2 weeks of experimental condition
Title
Change in inspiratory muscle function
Description
Inspiratory muscle function including strength, power and endurance will be assessed using the POWERbreathe KH2 device
Time Frame
Baseline up to following 2 weeks of experimental condition
Secondary Outcome Measure Information:
Title
Change in microvascular function
Description
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.
Time Frame
Baseline up to following 2 weeks of experimental condition
Title
Change in central arterial stiffness
Description
The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity.
Time Frame
Baseline up to following 2 weeks of experimental condition
Title
Change in central arterial hemodynamics
Description
The SphygmoCor XCEL device will be used to obtain central pulse wave analysis.
Time Frame
Baseline up to following 2 weeks of experimental condition
Title
Change in functional capacity
Description
Using the Duke Activity Status Index we will assess participants' ability to perform daily activities.
Time Frame
Baseline up to following 2 weeks of experimental condition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Demetra Christou, PhD
Phone
352-294-1746
Email
ddchristou@hhp.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Lapierre, MS
Email
ICPL@hhp.ufl.edu
Facility Information:
Facility Name
Integrative Cardiovascular Physiology Laboratory, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Demetra Christou, PhD
Phone
352-294-1746
Email
ddchristou@ufl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function

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