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
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Other: Classic Egg Group
Other: Omega 3 Egg Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: The Impact of Egg Consumption on Indices of Vascular Health in Individuals With Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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.



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. [ 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.



Enrollment: 60
Study Start Date: June 2010
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256320

Locations
Canada, Manitoba
IH Asper Clinical Research Institute, St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: James House, PhD University of Manitoba
  More Information

No publications provided

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
Study First Received: June 18, 2010
Last Updated: June 18, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014