Phase 3
N=110
Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT00781950 ↗Enrolled (actual)
110
Serious AEs
21.8%
Results posted
Dec 2014
Primary outcome: Primary: Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions — 4; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Flaxseed (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Dr. Grant Pierce
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions |
4; 5 | — |
| SECONDARY Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels. |
145.6; 136.2; 78.5; 71.8 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00781950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.