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

NCT02553733 | Unknown Phase 2 FDA Drug

• 1 other identifier: 00003242
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Dietary nitrate supplementation; Beetroot juice

Outcome Measures

Primary Outcomes (1)

• 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.

  5 to 7 days after initiating daily ingestion of beetroot juice

Secondary Outcomes (2)

• Coronary vascular function

  4 days after initiating daily ingestion of beetroot juice

• Leg vascular function

  4 days after initiating daily ingestion of beetroot juice

Other Outcomes (1)

• Blood measures of nitrate absorption and conversion

  4 to 7 days after initiating ingestion of beetroot juice

Study Arms (2)

Beetroot juice (Beet-It Organic Shot)

ACTIVE COMPARATOR

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.

Drug: Beetroot juice

Beetroot juice placebo (Beet-It Organic Placebo)

PLACEBO COMPARATOR

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.

Drug: Beetroot juice placebo

Interventions

Beetroot juice DRUG

This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).

Also known as: Beet-It Organic Shot

Beetroot juice (Beet-It Organic Shot)

Beetroot juice placebo DRUG

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).

Also known as: Beet-It organic placebo

Beetroot juice placebo (Beet-It Organic Placebo)

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David N. Proctor, PhD: lead
• Milton S. Hershey Medical Center: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• Kim DJ, Gao Z, Luck JC, Brandt K, Miller AJ, Kim-Shapiro D, Basu S, Leuenberger U, Gardner AW, Muller MD, Proctor DN. Effects of short-term dietary nitrate supplementation on exercise and coronary blood flow responses in patients with peripheral artery disease. Front Nutr. 2024 Jul 3;11:1398108. doi: 10.3389/fnut.2024.1398108. eCollection 2024.

  PMID: 39027664 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Urs A Leuenberger, MD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Kinesiology and Physiology

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 18, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

US (1)