The Effect of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease (FLAXPAD)
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Purpose
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 |
|---|---|---|
|
Peripheral Arterial Disease |
Dietary Supplement: Flaxseeds Dietary Supplement: Food Products |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| 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 |
- Primary outcome measures include the following events (all-cause mortality, cardiovascular mortality, stroke, myocardial infarctions, angina, arrhythmias) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Effects on exercise performance, blood pressure and circulating lipid levels. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Placebo Comparator: 1
Randomized, Blinded Controlled Arm of patients receiving placebo food products daily for two years
|
Dietary Supplement: Food Products
30 grams of food grain products per day
|
|
Experimental: 2
Randomized, Blinded group of patients that will be given Flaxseed food products daily for two years
|
Dietary Supplement: Flaxseeds
30 grams per day
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Randy Guzman, MD, FRCS(C), RVT, Clinical Investigator, St. Boniface General Hospital |
| ClinicalTrials.gov Identifier: | NCT00781950 History of Changes |
| Other Study ID Numbers: | 10941-011 |
| Study First Received: | October 28, 2008 |
| Last Updated: | October 30, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by St. Boniface General Hospital Research Centre:
|
PAD Peripheral Arterial Disease Diabetes Atherosclerosis Flax |
Flaxseeds Functional Foods Essential Fatty Acids Winnipeg |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013