Nitrites, Exercise, and Peripheral Arterial Disease

Duke University32 enrolled

Overview

The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic threshold (PET).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise TrainingDRUG

The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training.

Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise TrainingOTHER

The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Peripheral Arterial Disease (ABI of less than 0.9) * Intermittent Claudication for 3 or more months Exclusion Criteria: * Individuals with known alcohol or drug abuse problems * Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months * Those classified as American Heart Association Class D * Gangrene, impending limb loss or osteomyelitis * Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment * Severe peripheral neuropathy * Any condition other than PAD that limits walking * Chest pain during treadmill exercise which appears before the onset of claudication, or \>3mm ST depression during exercise * Subjects taking nitrates or nitroglycerin products * Must not be taking protein pump inhibitor medications

Locations (1)

Duke Diet & Fitness Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption)

Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.

Time frame: Baseline and 16 Weeks

Change In Time To Exhaustion

Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of total time to exhaustion.

Time frame: Baseline and 16 weeks

Secondary Outcomes

Change in Functional Ability

Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.

Time frame: Baseline and 16 Weeks

Change In Claudication Onset Time

Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of claudication onset time.

Time frame: Baseline and 16 weeks

Change In Vascular Function (BAFMD)

Vascular Function is measured as Brachial artery flow-mediated dilation (BAFMD). BAFMD is a measure of change in artery diameter after a stimulus .

Time frame: Baseline and 16 weeks

Change in Angiogenesis

Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups

Data from ClinicalTrials.gov

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