Egg Study With Peripheral Arterial Disease

NCT01256320 | Completed

• 1 other identifier: H2009:081:110
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  change in assessments from baseline to 8 weeks

Study Arms (3)

Control Group

NO INTERVENTION

no shell egg consumption and usual dietary practices

Classic Egg Group

ACTIVE COMPARATOR

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

Other: Classic Egg Group

Omega 3 Egg Group

ACTIVE COMPARATOR

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

Interventions

Classic Egg Group OTHER

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

Classic Egg Group

Omega 3 Egg Group OTHER

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

Omega 3 Egg Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

IH Asper Clinical Research Institute, St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (14)

• Calabro P, Yeh ET. The pleiotropic effects of statins. Curr Opin Cardiol. 2005 Nov;20(6):541-6. doi: 10.1097/01.hco.0000181482.99067.bf.

  PMID: 16234628 BACKGROUND

• Eberhardt RT, Coffman JD. Cardiovascular morbidity and mortality in peripheral arterial disease. Curr Drug Targets Cardiovasc Haematol Disord. 2004 Sep;4(3):209-17. doi: 10.2174/1568006043336230.

  PMID: 15379611 BACKGROUND

• 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.

  PMID: 16984798 BACKGROUND

• 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. doi: 10.1016/j.ijcard.2003.11.028.

  PMID: 15721501 BACKGROUND

• Kressel G, Trunz B, Bub A, Hulsmann 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.

  PMID: 18501910 BACKGROUND

• Lahera V, Goicoechea M, de Vinuesa SG, Miana M, de las Heras N, Cachofeiro V, Luno J. Endothelial dysfunction, oxidative stress and inflammation in atherosclerosis: beneficial effects of statins. Curr Med Chem. 2007;14(2):243-8. doi: 10.2174/092986707779313381.

  PMID: 17266583 BACKGROUND

• 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.

  PMID: 18586439 BACKGROUND

• 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

  BACKGROUND

• Raitakari et al. 2008 Br J Nutr 18:1

  BACKGROUND

• 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.

  PMID: 18289377 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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. doi: 10.1186/1471-2261-7-3.

  PMID: 17227586 BACKGROUND

• Weingartner O, Lutjohann D, Ji S, Weisshoff N, List F, Sudhop T, von Bergmann K, Gertz K, Konig J, Schafers HJ, Endres M, Bohm 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.

  PMID: 18420097 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• James House, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Deparment of Human Nutritional Sciences

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: December 8, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

CA (1)