Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01672567

Recruitment Status : Completed

First Posted : August 27, 2012

Last Update Posted : August 27, 2012

Sponsor:

Collaborator:

American Egg Board

Information provided by (Responsible Party):

Griffin Hospital

Study Description

Brief Summary:

The purpose of this study is to determine the effects of daily consumption of eggs or egg substitute for 6 weeks on endothelial function and on cholesterol and lipoprotein levels in participants with clinically established coronary heart disease (CHD).

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Dietary Supplement: Egg supplementation Dietary Supplement: Egg substitute Dietary Supplement: Control diet	Not Applicable

Detailed Description:

Restriction of dietary cholesterol, and thus the avoidance or restriction of egg intake, is routinely recommended to patients with coronary disease. However, the relative importance of dietary cholesterol to serum lipids has become a subject of active debate. Eggs provide a complete array of amino acids and an array of micronutrients, and are low in total fat. Epidemiological and clinical studies have showed that dietary intake of omega-3 fatty acids decreases the risk of coronary heart disease (CHD). Endothelial function testing represents a uniquely valuable means of assessing aggregated influences on cardiac risk by gauging physiologic responses of the vascular endothelium. In prior studies the investigators have shown that daily egg ingestion for 6 weeks did not adversely affect endothelial function in healthy adults or in hyperlipidemic adults. The investigators now propose a prospective, randomized, single-blind crossover study to assess the effects of eggs, egg substitute and high-carbohydrate American breakfast on endothelial responses and serum lipids in participants with clinically established CHD.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	34 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Investigator)
Primary Purpose:	Prevention
Official Title:	Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease: A Randomized, Controlled, Crossover Trial
Study Start Date :	October 2010
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Egg supplementation Daily consumption of 2 eggs for breakfast for 6 weeks	Dietary Supplement: Egg supplementation Daily consumption of 2 eggs for breakfast for 6 weeks
Experimental: Egg substitute Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks	Dietary Supplement: Egg substitute Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
Experimental: Control diet Daily consumption of high carbohydrate breakfast diet for 6 weeks, consisting of any of the following choices during each day of the treatment period: bagel, waffles, pancakes, or cereal and milk	Dietary Supplement: Control diet Daily consumption of high carbohydrate breakfast diet for 6 weeks, consisting of any of the following choices during each day of the treatment period: bagel, waffles, pancakes, or cereal and milk

Outcome Measures

Primary Outcome Measures :

Endothelial Function Flow mediated dilatation (FMD) as the percent change in brachial artery diameter from pre-cuff inflation to 60 seconds post-cuff release. [ Time Frame: 6 weeks ]
FMD will be measured as the percent change in brachial artery diameter from pre-cuff inflation to 60-seconds post-cuff release (upper arm cuff position). In addition to brachial diameter at 60 seconds post-cuff release, flow after cuff deflation within the first 15 seconds will be used as an indicator of stimulus strength, hyperemic flow being the stimulus for endothelial reactivity.

Secondary Outcome Measures :

Fasting Lipid Panel - Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio [ Time Frame: 6 weeks ]
Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio
3-Day Food Diary [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	35 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males age greater than 35 years;
Post-menopausal females not currently on hormone replacement therapy;
Non-smokers;
CVD as defined by the presence of at least one coronary stenosis >50% determined angiographically or a documented history of myocardial infarction.

Exclusion Criteria:

Failure to meet inclusion criteria;
Anticipated inability to complete study protocol for any reason;
Current eating disorder;
Use of lipid-lowering or antihypertensive medications unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to EF scanning;
Regular use of high doses of vitamin E or C;
Use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutraceuticals;
Regular use of fiber supplements;
Diabetes;
Sleep apnea;
Restricted diets by choice (i.e., vegetarian, vegan);
Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672567

Locations


United States, Connecticut
Griffin Hospital
Derby, Connecticut, United States, 06418

Sponsors and Collaborators

Griffin Hospital

American Egg Board

Investigators


Principal Investigator:	David L. Katz, MD, MPH	Yale-Griffin Prevention Research Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Katz DL, Gnanaraj J, Treu JA, Ma Y, Kavak Y, Njike VY. Effects of egg ingestion on endothelial function in adults with coronary artery disease: a randomized, controlled, crossover trial. Am Heart J. 2015 Jan;169(1):162-9. doi: 10.1016/j.ahj.2014.10.001. Epub 2014 Oct 7.


Responsible Party:	Griffin Hospital
ClinicalTrials.gov Identifier:	NCT01672567 History of Changes
Other Study ID Numbers:	2010/05
First Posted:	August 27, 2012 Key Record Dates
Last Update Posted:	August 27, 2012
Last Verified:	August 2012

Keywords provided by Griffin Hospital:


Coronary Artery Disease Egg Consumption Endothelial Function

Additional relevant MeSH terms:


Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases	Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases

To Top