Peripheral Arterial Disease
Conditions
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.
Interventions
OTHERClassic Egg Group
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs
OTHEROmega 3 Egg Group
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish quantitative and qualitative data on the dietary patterns, including egg consumption, in patients with PAD | change in assessments from baseline to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the impact of consuming 6 eggs per week on primary end-points and other modifiable risk factors in patients with PAD. | change in assessments from baseline to 8 weeks | 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. |
Countries
Canada
Outcome results
None listed