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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Grant Pierce, St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier:
NCT00781950
First received: October 28, 2008
Last updated: October 31, 2013
Last verified: October 2013
  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: Flaxseed
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

Resource links provided by NLM:


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, and arrhythmias) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects on exercise performance, blood pressure and circulating lipid levels. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat and wheat bran to replace the flaxseed daily for one year.
Experimental: Flaxseed
Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year
Dietary Supplement: Flaxseed
30 grams of milled flaxseed per day in food products or on its own.

Detailed 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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Dr. Grant Pierce
Investigators
Principal Investigator: Grant Pierce, PhD University of Manitoba
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Grant Pierce, Executive Director, Research Enterprise, St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier: NCT00781950     History of Changes
Other Study ID Numbers: 10941-011
Study First Received: October 28, 2008
Last Updated: October 31, 2013
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 October 01, 2014