Egg Study With Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256320
• Other study ID #: H2009:081:110
• Status: Completed
• Phase: N/A
• First received: June 18, 2010
• Last updated: May 1, 2017
• Start date: June 2010
• Est. completion date: February 2013

Study information

• Verified date: May 2017
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Classic Egg Group
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs
• Omega 3 Egg Group
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs

Locations

Country	Name	City	State
Canada	IH Asper Clinical Research Institute, St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (14)

Calabrò P, Yeh ET. The pleiotropic effects of statins. Curr Opin Cardiol. 2005 Nov;20(6):541-6. Review. — View Citation

Eberhardt RT, Coffman JD. Cardiovascular morbidity and mortality in peripheral arterial disease. Curr Drug Targets Cardiovasc Haematol Disord. 2004 Sep;4(3):209-17. Review. — View Citation

Ismail HM, Jackson K, Smith D. Diagnosis and treatment of peripheral arterial disease compared with other atherosclerotic vascular diseases in a university primary care clinic. J Investig Med. 2006 Jul;54(5):255-61. doi: 10.2310/6650.2006.05049. — View Citation

Katz DL, Evans MA, Nawaz H, Njike VY, Chan W, Comerford BP, Hoxley ML. Egg consumption and endothelial function: a randomized controlled crossover trial. Int J Cardiol. 2005 Mar 10;99(1):65-70. — View Citation

Kressel G, Trunz B, Bub A, Hülsmann O, Wolters M, Lichtinghagen R, Stichtenoth DO, Hahn A. Systemic and vascular markers of inflammation in relation to metabolic syndrome and insulin resistance in adults with elevated atherosclerosis risk. Atherosclerosis. 2009 Jan;202(1):263-71. doi: 10.1016/j.atherosclerosis.2008.04.012. Epub 2008 Apr 20. — View Citation

Lahera V, Goicoechea M, de Vinuesa SG, Miana M, de las Heras N, Cachofeiro V, Luño J. Endothelial dysfunction, oxidative stress and inflammation in atherosclerosis: beneficial effects of statins. Curr Med Chem. 2007;14(2):243-8. Review. — View Citation

Lane JS, Magno CP, Lane KT, Chan T, Hoyt DB, Greenfield S. Nutrition impacts the prevalence of peripheral arterial disease in the United States. J Vasc Surg. 2008 Oct;48(4):897-904. doi: 10.1016/j.jvs.2008.05.014. Epub 2008 Jun 30. — View Citation

Raitakari et al. 2008 Br J Nutr 18:1

Ratliff JC, Mutungi G, Puglisi MJ, Volek JS, Fernandez ML. Eggs modulate the inflammatory response to carbohydrate restricted diets in overweight men. Nutr Metab (Lond). 2008 Feb 20;5:6. doi: 10.1186/1743-7075-5-6. — View Citation

Shuaibi et al. 2008a; Journal of the American Dietetic Association, In Press

Shuaibi et al. 2008b; Journal of the American Dietetic Association, In Press

Third Report of the National Cholesterol Education Program (NCEP) on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel, ATP III) 2001; U.S. Department of Health & Human Services

Weatherley BD, Nelson JJ, Heiss G, Chambless LE, Sharrett AR, Nieto FJ, Folsom AR, Rosamond WD. The association of the ankle-brachial index with incident coronary heart disease: the Atherosclerosis Risk In Communities (ARIC) study, 1987-2001. BMC Cardiovasc Disord. 2007 Jan 16;7:3. — View Citation

Weingärtner O, Lütjohann D, Ji S, Weisshoff N, List F, Sudhop T, von Bergmann K, Gertz K, König J, Schäfers HJ, Endres M, Böhm M, Laufs U. Vascular effects of diet supplementation with plant sterols. J Am Coll Cardiol. 2008 Apr 22;51(16):1553-61. doi: 10.1016/j.jacc.2007.09.074. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change in assessments from baseline to 8 weeks
Secondary	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.	change in assessments from baseline to 8 weeks