Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT00781950
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
100 Years
Study:
NCT00781950
Study Brief:
Protocol Section:
NCT00781950