Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease (FLAXPAD)

Inclusion Criteria:

• Subjects with peripheral arterial disease for more than 6 months.
• Male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited IC but not incapacitated for walking on the level) confirmed with ankle/brachial pressures< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease.
• Over 40 years old
• Able to comply with protocol requirements
• Able to provide informed consent
• Subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study.
• Subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study.

Exclusion Criteria:

• Patients with ischemic rest pain in limbs, ulceration, or gangrene.
• At baseline, any condition that prevents walking on a treadmill.
• History of major bleeding.
• Patients with bowel disease (including Crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis).
• Patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with EF<40%, Canadian Cardiovascular Society Class 3 or 4 angina or need for coronary revascularization procedures).
• Moderate to severe renal failure.
• Subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study.
• Fish limitations (no more than 2 fish meals per week)
• Gluten allergy
• Subjects with allergies to any ingredient in the study product or placebo.
• Patients who plan to undergo surgery during the course of the trial.