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Egg Study With Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Classic Egg Group
Omega 3 Egg Group
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Peripheral Arterial Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • IH Asper Clinical Research Institute, St. Boniface General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control Group

Classic Egg Group

Omega 3 Egg Group

Arm Description

no shell egg consumption and usual dietary practices

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

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

Outcomes

Primary Outcome Measures

Establish quantitative and qualitative data on the dietary patterns, including egg consumption, in patients with PAD
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.

Secondary Outcome Measures

Determine the impact of consuming 6 eggs per week on primary end-points and other modifiable risk factors in patients with PAD.
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.

Full Information

First Posted
June 18, 2010
Last Updated
May 1, 2017
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01256320
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
no shell egg consumption and usual dietary practices
Arm Title
Classic Egg Group
Arm Type
Active Comparator
Arm Description
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs
Arm Title
Omega 3 Egg Group
Arm Type
Active Comparator
Arm Description
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs
Intervention Type
Other
Intervention Name(s)
Classic Egg Group
Intervention Description
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs
Intervention Type
Other
Intervention Name(s)
Omega 3 Egg Group
Intervention Description
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs
Primary Outcome Measure Information:
Title
Establish quantitative and qualitative data on the dietary patterns, including egg consumption, in patients with PAD
Description
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.
Time Frame
change in assessments from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Determine the impact of consuming 6 eggs per week on primary end-points and other modifiable risk factors in patients with PAD.
Description
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.
Time Frame
change in assessments from baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James House, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
IH Asper Clinical Research Institute, St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada

12. IPD Sharing Statement

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Egg Study With Peripheral Arterial Disease

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