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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 flaxseed. The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.
The proposed trial is a two year, double blinded, placebo controlled study designed to examine and compare the effects of dietary ground flaxseed supplementation in volunteers with claudication secondary to lower extremity atherosclerotic arterial disease (peripheral arterial disease). This patient population is likely to benefit from flaxseed because there is a high prevalence of accelerated atherosclerosis and a higher than normal incidence of arrhythmias, myocardial infarctions and stroke. This study will be focus on whether dietary flaxseed can reduce clinical manifestations of peripheral arterial disease and increase exercise capacity in these patients. Two general hypotheses will be tested in this proposal. First, we hypothesize that fewer primary and secondary events (all-cause mortality, cardiovascular mortality, stroke, myocardial infarctions, angina, arrhythmias) will occur in patients who ingest flaxseed in their diet. Secondly, we hypothesize that dietary flaxseed supplementation will be associated with beneficial effects on exercise performance, blood pressure and circulating lipid levels. This trial will generate data on the safety, tolerability, cardiovascular efficacy and genomic response to a diet rich in flaxseed in patients with peripheral arterial disease (PAD).
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Peripheral Arterial Disease
Flaxseeds, Food Products
Enrolling by invitation
St. Boniface General Hospital Research Centre
Published on BioPortfolio: 2014-08-27T03:26:38-0400
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