Nitrites, Exercise, and Peripheral Arterial Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

BR Juice Placebo and Exercise Training

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.

Group Type PLACEBO_COMPARATOR

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

Intervention Type OTHER

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.

Interventions

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

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.

Intervention Type DRUG

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

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.

Intervention Type OTHER

Other Intervention Names

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James White Drinks James White Drinks

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No