Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-06-30

Brief Summary

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The overarching question addressed in the current project is: Does dietary nitrate supplementation (8 weeks) improve physiological function in patients with peripheral arterial disease (PAD)? The investigators will specifically address whether dietary nitrate supplementation enhances blood vessel function, blood pressure regulation, and exercise capacity. The proposed project uses an array of clearly defined measurements which will allow investigators to quantify blood vessel function (vasodilator responsiveness and arterial stiffness), blood pressure (variability and responsiveness to stress), and functional capacity before and after 8 weeks of dietary supplementation.

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Detailed Description

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Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sodium Nitrate

Sodium Nitrate (1g/day) for 8 weeks

Group Type EXPERIMENTAL

Sodium Nitrate

Intervention Type DIETARY_SUPPLEMENT

Sodium Nitrate (1g/day) for 8 weeks

Placebo capsule

Microcrystalline cellulose (daily) for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Microcrystalline cellulose (daily) for 8 weeks

Interventions

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Sodium Nitrate

Sodium Nitrate (1g/day) for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Microcrystalline cellulose (daily) for 8 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Documented peripheral artery disease
* Ankle-Brachial Index (ABI) \< or = to 0.90

Exclusion Criteria

* Non-atherosclerotic vascular disease
* Critical limb ischemia
* Active ischemic ulceration
* Recent (within one year) revascularization
* Symptomatic coronary artery disease (angina pectoris)
* Heart failure
* Resting systolic blood pressure \> 180 mmHg or diastolic pressure \> 100 mmHg
* Hypotension (resting systolic BP \< 90 mmHg)
* Smoking or history of smoking within past one year
* Use of phosphodiesterase V inhibitor drugs
* Women with history of hormone replacement therapy within the past 6 months

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No