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Effect of Beetroot Juice on Coronary Blood Flow and Walking Performance in PAD (HeartBeet)

Primary Purpose

Peripheral Arterial Disease

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Beetroot juice
Beetroot juice placebo
Sponsored by
David N. Proctor, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Dietary nitrate supplementation, Beetroot juice

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with peripheral arterial disease (PAD)
  2. Capable of giving informed consent
  3. Men and women age 21- 85 years
  4. Diagnosed with PAD (i.e., ankle-brachial index below 0.9)
  5. Fontaine stage II or less - no pain while resting
  6. Satisfactory history and physical exam

Exclusion Criteria:

  1. Children
  2. Pregnant or nursing women
  3. Patients taking nitroglycerine or nitrate preparations
  4. Patients taking phosphodiesterase inhibitors such as sildenafil or tadalafil
  5. Patients taking proton pump inhibitors
  6. Ejection fraction < 40%
  7. Uncontrolled hypertension
  8. Uncontrolled diabetes
  9. Myocardial infarction within past 6 months or unstable angina
  10. Severe lung disease (i.e., on supplemental oxygen or frequently use rescue inhalers)
  11. Abnormality in hemoglobin or hematocrit or methemoglobin
  12. Impaired renal function
  13. Impaired liver function
  14. History or diagnosis of Barrett's esophagus
  15. Known allergy to beetroot juice or lemon juice
  16. Inability to walk on a treadmill at a moderate pace (2.0 miles/hour)

Sites / Locations

  • Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Beetroot juice (Beet-It Organic Shot)

Beetroot juice placebo (Beet-It Organic Placebo)

Arm Description

Subjects will consume 70 ml of beetroot juice (Beet-It Organic Shot) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.

Subjects will consume 70 ml of beetroot juice placebo (Beet-It Organic Placebo) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.

Outcomes

Primary Outcome Measures

Exercise performance
Exercise capacity will be assessed using a graded treadmill walking test to peak exertion with expired gas analysis and determination of peak oxygen uptake, calf muscle oxygenation, blood pressure, claudication onset time, and peak walking time.

Secondary Outcome Measures

Coronary vascular function
Coronary artery (transthoracic ultrasound) blood flow responses to plantar flexion and handgrip exercise.
Leg vascular function
Popliteal artery and near infrared spectroscopy (NIRS) responses to plantar flexion and handgrip exercise.

Full Information

First Posted
September 15, 2015
Last Updated
April 5, 2023
Sponsor
David N. Proctor, PhD
Collaborators
Milton S. Hershey Medical Center, Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02553733
Brief Title
Effect of Beetroot Juice on Coronary Blood Flow and Walking Performance in PAD
Acronym
HeartBeet
Official Title
Effects of Dietary Nitrate Supplementation on Coronary Blood Flow and Walking Performance in Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David N. Proctor, PhD
Collaborators
Milton S. Hershey Medical Center, Wake Forest University Health Sciences

4. Oversight

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

5. Study Description

Brief Summary
In this study the investigators will test the hypothesis that short-term consumption of inorganic nitrate (supplied in concentrated beetroot juice) enhances coronary blood flow responses, large artery hemodynamics, and leg oxygenation/exercise tolerance in patients with peripheral arterial disease (PAD). Understanding and improving blood flow regulation in the heart and skeletal muscles of patients with PAD is important because exercise triggers symptoms of leg pain and substantially raises blood pressure and myocardial demand in these patients.
Detailed Description
Peripheral arterial disease (PAD) is a strong predictor of cardiovascular mortality and negatively affects functional capacity and quality of life for as many as 14 million patients in the U.S. alone. One open-label study showed that acute consumption of beetroot juice improved 6 min walk performance, reduced blood pressure, and enhanced leg muscle oxygenation in PAD patients. However, no studies have rigorously confirmed these findings in a double-blind manner, nor have the effects of this supplement been investigated (acutely or short-term) in the coronary circulation of PAD patients. In addition to studying its effects on graded treadmill walking performance and consequent large artery vasodilation, the present study will examine the effects of short-term beetroot juice consumption (twice/day) on both coronary and leg vasodilator (graded calf flexion) and vasoconstrictor (isometric handgrip, voluntary apnea) responses in patients with PAD. Participants will randomly consume either nitrate-rich or nitrate-depleted beetroot juice with a 7 to 14 day wash-out period between. Effects of beetroot juice consumption on plasma nitrate, nitrite and methemoglobin will also be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Dietary nitrate supplementation, Beetroot juice

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beetroot juice (Beet-It Organic Shot)
Arm Type
Active Comparator
Arm Description
Subjects will consume 70 ml of beetroot juice (Beet-It Organic Shot) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Arm Title
Beetroot juice placebo (Beet-It Organic Placebo)
Arm Type
Placebo Comparator
Arm Description
Subjects will consume 70 ml of beetroot juice placebo (Beet-It Organic Placebo) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Intervention Type
Drug
Intervention Name(s)
Beetroot juice
Other Intervention Name(s)
Beet-It Organic Shot
Intervention Description
This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
Intervention Type
Drug
Intervention Name(s)
Beetroot juice placebo
Other Intervention Name(s)
Beet-It organic placebo
Intervention Description
This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
Primary Outcome Measure Information:
Title
Exercise performance
Description
Exercise capacity will be assessed using a graded treadmill walking test to peak exertion with expired gas analysis and determination of peak oxygen uptake, calf muscle oxygenation, blood pressure, claudication onset time, and peak walking time.
Time Frame
5 to 7 days after initiating daily ingestion of beetroot juice
Secondary Outcome Measure Information:
Title
Coronary vascular function
Description
Coronary artery (transthoracic ultrasound) blood flow responses to plantar flexion and handgrip exercise.
Time Frame
4 days after initiating daily ingestion of beetroot juice
Title
Leg vascular function
Description
Popliteal artery and near infrared spectroscopy (NIRS) responses to plantar flexion and handgrip exercise.
Time Frame
4 days after initiating daily ingestion of beetroot juice
Other Pre-specified Outcome Measures:
Title
Blood measures of nitrate absorption and conversion
Description
Venous blood will be withdrawn (venipuncture) for determination of plasma nitrate, nitrite and methemoglobin levels
Time Frame
4 to 7 days after initiating ingestion of beetroot juice

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with peripheral arterial disease (PAD) Capable of giving informed consent Men and women age 21- 85 years Diagnosed with PAD (i.e., ankle-brachial index below 0.9) Fontaine stage II or less - no pain while resting Satisfactory history and physical exam Exclusion Criteria: Children Pregnant or nursing women Patients taking nitroglycerine or nitrate preparations Patients taking phosphodiesterase inhibitors such as sildenafil or tadalafil Patients taking proton pump inhibitors Ejection fraction < 40% Uncontrolled hypertension Uncontrolled diabetes Myocardial infarction within past 6 months or unstable angina Severe lung disease (i.e., on supplemental oxygen or frequently use rescue inhalers) Abnormality in hemoglobin or hematocrit or methemoglobin Impaired renal function Impaired liver function History or diagnosis of Barrett's esophagus Known allergy to beetroot juice or lemon juice Inability to walk on a treadmill at a moderate pace (2.0 miles/hour)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urs A Leuenberger, MD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Effect of Beetroot Juice on Coronary Blood Flow and Walking Performance in PAD

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