The Effect of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease - Full Text View

Sponsored by:	St. Boniface General Hospital Research Centre
Information provided by:	St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier:	NCT00781950

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 II Phase III

MedlinePlus related topics: Dietary Supplements Exercise and Physical Fitness

U.S. FDA Resources

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

Further study details as provided by St. Boniface General Hospital Research Centre:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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
1: Placebo Comparator 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
2: Experimental 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781950

Sponsors and Collaborators

St. Boniface General Hospital Research Centre

Investigators

Principal Investigator:

Grant Pierce, PhD

University of Manitoba

More Information

Canadian Centre for Agri-food Research in Health and Medicine This link exits the ClinicalTrials.gov site

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

Keywords provided by St. Boniface General Hospital Research Centre:

PAD
Peripheral Arterial Disease
Diabetes
Atherosclerosis
Flax

Flaxseeds
Functional Foods
Essential Fatty Acids
Winnipeg

Study placed in the following topic categories:

Atherosclerosis
Peripheral Vascular Diseases
Vascular Diseases
Diabetes Mellitus

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009