Back to resultsEffects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease (FLAXPAD)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Flaxseed
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Peripheral Arterial Disease focused on measuring PAD, Peripheral Arterial Disease, Diabetes, Atherosclerosis, Flax, Flaxseeds, Functional Foods, Essential Fatty Acids, Winnipeg
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Flaxseed
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions
Secondary Outcome Measures
Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00781950
Brief Title
Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
Acronym
FLAXPAD
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Grant Pierce
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
PAD, Peripheral Arterial Disease, Diabetes, Atherosclerosis, Flax, Flaxseeds, Functional Foods, Essential Fatty Acids, Winnipeg
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Flaxseed
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Flaxseed
Intervention Description
30 grams of milled flaxseed per day in food products or on its own.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Wheat and Mixed Dietary Oils
Primary Outcome Measure Information:
Title
Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant Pierce, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
27528063
Citation
Caligiuri SP, Rodriguez-Leyva D, Aukema HM, Ravandi A, Weighell W, Guzman R, Pierce GN. Dietary Flaxseed Reduces Central Aortic Blood Pressure Without Cardiac Involvement but Through Changes in Plasma Oxylipins. Hypertension. 2016 Oct;68(4):1031-8. doi: 10.1161/HYPERTENSIONAHA.116.07834. Epub 2016 Aug 15.
Results Reference
derived
PubMed Identifier
25694068
Citation
Edel AL, Rodriguez-Leyva D, Maddaford TG, Caligiuri SP, Austria JA, Weighell W, Guzman R, Aliani M, Pierce GN. Dietary flaxseed independently lowers circulating cholesterol and lowers it beyond the effects of cholesterol-lowering medications alone in patients with peripheral artery disease. J Nutr. 2015 Apr;145(4):749-57. doi: 10.3945/jn.114.204594. Epub 2015 Feb 18.
Results Reference
derived
PubMed Identifier
24777981
Citation
Caligiuri SP, Aukema HM, Ravandi A, Guzman R, Dibrov E, Pierce GN. Flaxseed consumption reduces blood pressure in patients with hypertension by altering circulating oxylipins via an alpha-linolenic acid-induced inhibition of soluble epoxide hydrolase. Hypertension. 2014 Jul;64(1):53-9. doi: 10.1161/HYPERTENSIONAHA.114.03179. Epub 2014 Apr 28.
Results Reference
derived
Links:
URL
http://www.sbrc.ca/ccarm
Description
Canadian Centre for Agri-food Research in Health and Medicine
Learn more about this trial
Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
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