Peripheral Arterial DiseaseNCT01256320
Egg Study With Peripheral Arterial Disease
A study testing Classic Egg Group and Omega 3 Egg Group in people with Peripheral Arterial Disease, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Classic Egg Group and Omega 3 Egg Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
IH Asper Clinical Research Institute, St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Classic Egg Group, Omega 3 Egg Group
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic Egg GroupOther
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs
Omega 3 Egg GroupOther
consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Omega 3 Egg Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: change in assessments from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. J. House, University of Manitoba
- Investigators
- James House, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256320
- Sponsor's protocol ID
- H2009:081:110
- Status last verified
- May 2017
- First submitted
- 18 Jun 2010
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16234628Eberhardt 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.
PubMed 15379611Ismail 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.
PubMed 16984798Katz 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.
PubMed 15721501Kressel 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.
PubMed 18501910Lahera 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.
PubMed 17266583Lane 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.
PubMed 18586439Third 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
Raitakari et al. 2008 Br J Nutr 18:1
Ratliff et al. Nutr Metab 5:6 2008
Shuaibi et al. 2008a; Journal of the American Dietetic Association, In Press
Shuaibi et al. 2008b; Journal of the American Dietetic Association, In Press
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.
PubMed 17227586Weingartner 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.
PubMed 18420097
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Egg Consumption on Indices of Vascular Health in Individuals With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01256320
- Acronym / sponsor ID
- H2009:081:110
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –no shell egg consumption and usual dietary practices |
| Classic Egg Group | Active comparator | Other: Classic Egg Groupconsumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs |
| Omega 3 Egg Group | Active comparator | Other: Omega 3 Egg Groupconsumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classic Egg Groupconsumption 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 Groupconsumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs | Other | Omega 3 Egg Group |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Background: PubMed 16234628Calabro 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.
- Background: PubMed 15379611Eberhardt 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.
- Background: PubMed 16984798Ismail 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.
- Background: PubMed 15721501Katz 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.
- Background: PubMed 18501910Kressel 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.
- Background: PubMed 17266583Lahera 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.
- Background: PubMed 18586439Lane 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.
- BackgroundThird 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
- BackgroundRaitakari et al. 2008 Br J Nutr 18:1
- BackgroundRatliff et al. Nutr Metab 5:6 2008
- BackgroundShuaibi et al. 2008a; Journal of the American Dietetic Association, In Press
- BackgroundShuaibi et al. 2008b; Journal of the American Dietetic Association, In Press
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James House, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic Egg Group and Omega 3 Egg Group in people with Peripheral Arterial Disease, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01256320, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.