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

Tracking Information
First Submitted Date ICMJE	August 9, 2011
First Posted Date ICMJE	August 27, 2012
Last Update Posted Date	August 27, 2012
Study Start Date ICMJE	October 2010
Actual Primary Completion Date	April 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 22, 2012)	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; (submitted: August 22, 2012)	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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (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
Actual Enrollment ICMJE; (submitted: August 22, 2012)	34
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	April 2012
Actual 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	No
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	No
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