Clinical trial NCT01256320: Egg Study With Peripheral Arterial Disease
Official title: The Impact of Egg Consumption on Indices of Vascular Health in Individuals With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Establish quantitative and qualitative data on the dietary patterns, including egg consumption, in patients with PAD
timeFrame: change in assessments from baseline to 8 weeks
Secondary outcomes:
measure: Determine the impact of consuming 6 eggs per week on primary end-points and other modifiable risk factors in patients with PAD.
timeFrame: change in assessments from baseline to 8 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: IH Asper Clinical Research Institute, St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: James House, PhD
role: PRINCIPAL_INVESTIGATOR
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