Egg Study With Peripheral Arterial Disease

University of Manitoba

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Other: Omega 3 Egg Group; Other: Classic Egg Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01256320

H2009:081:110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 3 patient groups

Control Group

No Intervention group

Description:

no shell egg consumption and usual dietary practices

Classic Egg Group

Active Comparator group

Description:

consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs

Treatment:

Other: Classic Egg Group

Omega 3 Egg Group

Active Comparator group

Description:

consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs

Treatment:

Other: Omega 3 Egg Group