Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease

University of Iowa

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Other: Placebo; Dietary Supplement: Sodium Nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01983826

201307745

13GRNT16490002 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Sodium Nitrate

Experimental group

Description:

Sodium Nitrate (1g/day) for 8 weeks

Treatment:

Dietary Supplement: Sodium Nitrate

Placebo capsule

Placebo Comparator group

Description:

Microcrystalline cellulose (daily) for 8 weeks

Treatment:

Other: Placebo