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Sponsored by: |
St. Boniface General Hospital Research Centre |
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Information provided by: | St. Boniface General Hospital Research Centre |
ClinicalTrials.gov Identifier: | NCT00781950 |
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.
Condition | Intervention | Phase |
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Peripheral Arterial Disease |
Dietary Supplement: Flaxseeds Dietary Supplement: Food Products |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 250 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Randomized, Blinded Controlled Arm of patients receiving placebo food products daily for two years
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Dietary Supplement: Food Products
30 grams of food grain products per day
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2: Experimental
Randomized, Blinded group of patients that will be given Flaxseed food products daily for two years
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Dietary Supplement: Flaxseeds
30 grams per day
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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).
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | St. Boniface General Hospital ( Dr. Randy Guzman, MD, FRCS(C), RVT, Clinical Investigator ) |
Study ID Numbers: | 10941-011 |
Study First Received: | October 28, 2008 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00781950 |
Health Authority: | Canada: Health Canada |
PAD Peripheral Arterial Disease Diabetes Atherosclerosis Flax |
Flaxseeds Functional Foods Essential Fatty Acids Winnipeg |
Atherosclerosis Peripheral Vascular Diseases Vascular Diseases Diabetes Mellitus |
Cardiovascular Diseases |