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:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT01256320
Eligibility Criteria:
Inclusion Criteria:
1. Presence of peripheral arterial disease including those with claudication as defined by an ankle brachial index of ≤ 0.90 or asymptomatic carotid stenosis of \> 50%; or who have had a previous intervention for peripheral arterial disease;
2. Male or female, \> 40 years of age;
3. Willing to comply with the protocol requirements;
4. Willing to provide informed consent;
5. Stable medication profile with no changes anticipated for the duration of the proposed study schedule (8 weeks);
6. Participants having completed the Flax Study are eligible to participate if their completion has been more than 3 months.
Exclusion Criteria:
1. Renal failure requiring dialysis;
2. Diabetes, requiring diabetic medication; Participants with diabetes who do not require diabetic medication and have good glycemic control will be eligible for participation in the study. Participant with elevated fasting blood glucose levels and glycated hemoglobin above 'standard of care' at baseline will not proceed with the study;
3. Hyperlipidemia as defined by a cholesterol of \>4.1 mmol/L (as per the National Cholesterol Education Program Adult Treatment Panel III, (NCEP ATP III) guidelines;
4. Hormone replacement therapy;
5. Inability to adhere to a regular diet;
6. Habitual egg intake of 5 or more eggs per week;
7. History of gastrointestinal reactions or allergies to eggs;
8. Daily consumption of omega-3 supplements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01256320
Study Brief:
Protocol Section:
NCT01256320