Nitrites, Exercise, and Peripheral Arterial Disease (NO-PAD)

Duke University

Status and phase: Completed; Phase 2

Conditions: Peripheral Arterial Disease

Treatments: Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training; Drug: Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01684930

Pro00031918

1R21HL111972-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 32 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

BR Juice (Beet-It Stamina Shot) and Exercise Training

Experimental group

Description:

Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 \& 2) and at the end of the trial (between Visits 3 \& 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 \& 3) to when the subject has not consumed the beverage (Visits 1 \& 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 \& 3 and for all supervised exercise training visits during the 12 week intervention.

Treatment:

Drug: Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training

BR Juice Placebo and Exercise Training

Placebo Comparator group

Description:

Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 \& 2) and at the end of the trial (between Visits 3 \& 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 \& 3) to when the subject has not consumed the beverage (Visits 1 \& 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 \& 3 and for all supervised exercise training visits during the 12 week intervention.

Treatment:

Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training