Egg Study With Peripheral Arterial Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. J. House, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01256320
First received: June 18, 2010
Last updated: June 18, 2013
Last verified: June 2013

June 18, 2010
June 18, 2013
June 2010
December 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]

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.

Establish quantitative and qualitative data on the dietary patterns, including egg consumption, in patients with PAD [ Time Frame: change in assessments from baseline at 8 weeks ] [ Designated as safety issue: No ]

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.

Complete list of historical versions of study NCT01256320 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]

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 at 8 weeks ] [ Designated as safety issue: Yes ]

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.

Not Provided
Not Provided
 
Egg Study With Peripheral Arterial Disease
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Peripheral Arterial Disease
  • Other: Classic Egg Group
    consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic 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
  • 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
    Intervention: Other: Classic Egg Group
  • 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
    Intervention: Other: Omega 3 Egg Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01256320
H2009:081:110
No
Dr. J. House, University of Manitoba
University of Manitoba
Not Provided
Principal Investigator: James House, PhD University of Manitoba
University of Manitoba
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP