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

Peripheral Arterial Disease Clinical Trial

Official title: A Double Blind, Randomized, Placebo Controlled, Study for Assessment of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease

Status Active, not recruiting

Clinical Trial 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 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.

Clinical Trial 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 secondary to lower extremity atherosclerotic arterial disease (peripheral arterial disease). The original proposal was for a two year study duration but this was truncated at one year to insure patient compliance remained high. 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

• NCT number: NCT00781950
• Study type: Interventional
• Source: St. Boniface General Hospital Research Centre
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: October 2008
• Completion date: December 2017