Status:
COMPLETED
Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
Lead Sponsor:
Dr. Grant Pierce
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40-100 years
Phase:
PHASE2
PHASE3
Brief Summary
This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of f...
Detailed Description
The proposed trial is a one year, double blinded, placebo controlled study designed to examine and compare the effects of dietary ground flaxseed supplementation in volunteers with claudication second...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00781950
Start Date
October 1 2008
End Date
October 1 2016
Last Update
December 12 2016
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