Egg Study With Peripheral Arterial Disease

May 1, 2017 updated by: Dr. J. House, University of Manitoba

The Impact of Egg Consumption on Indices of Vascular Health in Individuals With Peripheral Arterial Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • IH Asper Clinical Research Institute, St. Boniface General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change in assessments from baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change in assessments from baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: James House, PhD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 18, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (Estimate)

December 8, 2010

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2009:081:110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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