Egg Study With Peripheral Arterial Disease

Study Overview
=================
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 disease. Any one of three potential outcomes may be observed as a result of this study, and they are predicted as follows: 1) Egg consumption does not lead to a deterioration of indices of cardiovascular health; 2) Egg consumption improves indices of cardiovascular health; 3) Egg consumption worsens the indices of cardiovascular health.

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 consumption in the peripheral arterial disease and the healthy population. If the last prediction is positive, while least favourable, it will still establish important information to assist the industry in their efforts toward establishing population-specific nutrition messaging.

Official Title
-----------------
The Impact of Egg Consumption on Indices of Vascular Health in Individuals With Peripheral Arterial Disease

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Other: Classic Egg Group
* Other: Omega 3 Egg Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>no shell egg consumption and usual dietary practices | |
| Active Comparator: Classic Egg Group<br>consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs | Other: Classic Egg Group<br>* consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs<br>|
| Active Comparator: Omega 3 Egg Group<br>consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs | Other: Omega 3 Egg Group<br>* consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish quantitative and qualitative data on the dietary patterns, including egg consumption, in patients with PAD | The following assessments are included to measure the primary outcome: 1)Anthropometrics: weight, height; waist circumference, Body Mass Index; 2)Dietary Assessment:3-day dietary food record, food frequency questionnaire (baseline only); 3)Biochemical Analyses; 4)Expression and Metabolic Profiling; 5)Arterial Compliance: Ankle-brachial index, pulse wave velocity, arterial vasodilation, and advanced glycation endproducts; 6) Semi-structured interview. | change in assessments from baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the impact of consuming 6 eggs per week on primary end-points and other modifiable risk factors in patients with PAD. | The following assessments are included to measure the primary outcome: 1)Anthropometrics: weight, height; waist circumference, Body Mass Index; 2)Dietary Assessment:3-day dietary food record, food frequency questionnaire (baseline only); 3)Biochemical Analyses; 4)Expression and Metabolic Profiling; 5)Arterial Compliance: Ankle-brachial index, pulse wave velocity, arterial vasodilation, and advanced glycation endproducts; 6) Semi-structured interview. | change in assessments from baseline to 8 weeks |