Egg Study With Peripheral Arterial Disease

NCT ID: NCT01256320

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-02-28

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control Group

no shell egg consumption and usual dietary practices

Group Type: NO_INTERVENTION

No interventions assigned to this group

Classic Egg Group

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

Group Type: ACTIVE_COMPARATOR

Classic Egg Group

Intervention Type: OTHER

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

Omega 3 Egg Group

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

Group Type: ACTIVE_COMPARATOR

Omega 3 Egg Group

Intervention Type: OTHER

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

Interventions

Classic Egg Group

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

Intervention Type: OTHER

Omega 3 Egg Group

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. J. House

Professor and Head, Deparment of Human Nutritional Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James House, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

IH Asper Clinical Research Institute, St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

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Other Identifiers

H2009:081:110

Identifier Type: -

Identifier Source: org_study_id