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

This study has been completed.

Sponsor:

Collaborator:

American Egg Board

Information provided by (Responsible Party):

Griffin Hospital

ClinicalTrials.gov Identifier:

NCT01672567

First received: August 9, 2011

Last updated: August 22, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 9, 2011

Last Updated Date

August 22, 2012

Start Date ^ICMJE

October 2010

Primary Completion Date

April 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease: A Randomized, Controlled, Crossover Trial

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).

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Dietary Supplement: Egg supplementation
Daily consumption of 2 eggs for breakfast for 6 weeks
Dietary Supplement: Egg substitute
Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
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

Study Arms

Experimental: Egg supplementation
Daily consumption of 2 eggs for breakfast for 6 weeks

Intervention: Dietary Supplement: Egg supplementation
Experimental: Egg substitute
Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks

Intervention: Dietary Supplement: Egg substitute
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

Intervention: Dietary Supplement: Control diet

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

35 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01672567

Other Study ID Numbers ^ICMJE

2010/05

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Griffin Hospital

Study Sponsor ^ICMJE

Griffin Hospital

Collaborators ^ICMJE

American Egg Board

Investigators ^ICMJE

Principal Investigator:

David L. Katz, MD, MPH

Yale-Griffin Prevention Research Center

PRS Account

Griffin Hospital

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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