Status:
COMPLETED
Egg Study With Peripheral Arterial Disease
Lead Sponsor:
University of Manitoba
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The current research study has the potential to generate data that would provide solid clinical endpoints as to the impact of including eggs in a regular diet in individuals with peripheral arterial d...
Detailed Description
Given the hypotheses proposed, if either of the first two predictions prove to be positive, they will help encourage directive efforts to be made toward effective nutrition messages for egg consumptio...
Eligibility Criteria
Inclusion
- 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;
- Male or female, \> 40 years of age;
- Willing to comply with the protocol requirements;
- Willing to provide informed consent;
- Stable medication profile with no changes anticipated for the duration of the proposed study schedule (8 weeks);
- Participants having completed the Flax Study are eligible to participate if their completion has been more than 3 months.
Exclusion
- Renal failure requiring dialysis;
- 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;
- 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;
- Hormone replacement therapy;
- Inability to adhere to a regular diet;
- Habitual egg intake of 5 or more eggs per week;
- History of gastrointestinal reactions or allergies to eggs;
- Daily consumption of omega-3 supplements.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01256320
Start Date
June 1 2010
End Date
February 1 2013
Last Update
May 4 2017
Active Locations (1)
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1
IH Asper Clinical Research Institute, St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6