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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02553733
Recruitment Status : Active, not recruiting
First Posted : September 18, 2015
Last Update Posted : February 3, 2022
Sponsor:
Collaborators:
Milton S. Hershey Medical Center
Wake Forest University Health Sciences
Information provided by (Responsible Party):
David N. Proctor, PhD, Penn State University

Tracking Information
First Submitted Date  ICMJE September 15, 2015
First Posted Date  ICMJE September 18, 2015
Last Update Posted Date February 3, 2022
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
Exercise performance [ Time Frame: 5 to 7 days after initiating daily ingestion of beetroot juice ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
  • Coronary vascular function [ Time Frame: 4 days after initiating daily ingestion of beetroot juice ]
    Coronary artery (transthoracic ultrasound) blood flow responses to plantar flexion and handgrip exercise.
  • Leg vascular function [ Time Frame: 4 days after initiating daily ingestion of beetroot juice ]
    Popliteal artery and near infrared spectroscopy (NIRS) responses to plantar flexion and handgrip exercise.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
  • Coronary vascular function [ Time Frame: 4 days after initiating daily ingestion of beetroot juice ]
    Coronary artery (transthoracic ultrasound) blood flow responses to plantar flexion and handgrip exercise.
  • Leg vascular function [ Time Frame: 4 days after initiating daily ingestion of beetroot juice ]
    Popliteal artery and near infrared spectroscopy (NIRS) responses to plantar flexion and handgrip exercise.
  • Hypoxic coronary vascular function [ Time Frame: 4 days after initiating daily ingestion of beetroot juice ]
    Coronary artery (transthoracic ultrasound) blood flow responses to 10% inspired oxygen breathing at rest and during graded plantar flexion exercise.
  • Hypoxic leg vascular function [ Time Frame: 4 days after initiating daily ingestion of beetroot juice ]
    Popliteal artery and near infrared spectroscopy (NIRS) responses to 10% inspired oxygen breathing at rest and during graded plantar flexion exercise.
Current Other Pre-specified Outcome Measures
 (submitted: September 15, 2015)
Blood measures of nitrate absorption and conversion [ Time Frame: 4 to 7 days after initiating ingestion of beetroot juice ]
Venous blood will be withdrawn (venipuncture) for determination of plasma nitrate, nitrite and methemoglobin levels
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Beetroot Juice on Coronary Blood Flow and Walking Performance in PAD
Official Title  ICMJE Effects of Dietary Nitrate Supplementation on Coronary Blood Flow and Walking Performance in Peripheral Arterial Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE
  • Drug: Beetroot juice
    This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
    Other Name: Beet-It Organic Shot
  • Drug: Beetroot juice placebo
    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).
    Other Name: Beet-It organic placebo
Study Arms  ICMJE
  • Active Comparator: Beetroot juice (Beet-It Organic Shot)
    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.
    Intervention: Drug: Beetroot juice
  • Placebo Comparator: Beetroot juice placebo (Beet-It Organic Placebo)
    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: Drug: Beetroot juice placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2015)
24
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02553733
Other Study ID Numbers  ICMJE 00003242
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party David N. Proctor, PhD, Penn State University
Original Responsible Party David N. Proctor, Penn State University, Professor of Kinesiology and Physiology
Current Study Sponsor  ICMJE David N. Proctor, PhD
Original Study Sponsor  ICMJE David N. Proctor
Collaborators  ICMJE
  • Milton S. Hershey Medical Center
  • Wake Forest University Health Sciences
Investigators  ICMJE
Principal Investigator: Urs A Leuenberger, MD Penn State University
PRS Account Penn State University
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP