Egg Study With Peripheral Arterial Disease
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ClinicalTrials.gov Identifier: NCT01256320 |
Recruitment Status
:
Completed
First Posted
: December 8, 2010
Last Update Posted
: May 4, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Arterial Disease | Other: Classic Egg Group Other: Omega 3 Egg Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Other |
Official Title: | The Impact of Egg Consumption on Indices of Vascular Health in Individuals With Peripheral Arterial Disease |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | February 2013 |

Arm | Intervention/treatment |
---|---|
No Intervention: Control Group
no shell egg consumption and usual dietary practices
|
|
Active Comparator: Classic Egg Group
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs
|
Other: Classic Egg Group
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs
|
Active Comparator: Omega 3 Egg Group
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
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs
|
- Establish quantitative and qualitative data on the dietary patterns, including egg consumption, in patients with PAD [ Time Frame: 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.
- Determine the impact of consuming 6 eggs per week on primary end-points and other modifiable risk factors in patients with PAD. [ Time Frame: 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.

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256320
Canada, Manitoba | |
IH Asper Clinical Research Institute, St. Boniface General Hospital | |
Winnipeg, Manitoba, Canada, R2H 2A6 |
Principal Investigator: | James House, PhD | University of Manitoba |
Publications:
Responsible Party: | Dr. J. House, Professor and Head, Deparment of Human Nutritional Sciences, University of Manitoba |
ClinicalTrials.gov Identifier: | NCT01256320 History of Changes |
Other Study ID Numbers: |
H2009:081:110 |
First Posted: | December 8, 2010 Key Record Dates |
Last Update Posted: | May 4, 2017 |
Last Verified: | May 2017 |
Additional relevant MeSH terms:
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |