Clinical trial NCT01672567: Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease
Official title: Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease: A Randomized, Controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Egg Consumption
Endothelial Function
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2012-08-27
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Failure to meet inclusion criteria;
2. Anticipated inability to complete study protocol for any reason;
3. Current eating disorder;
4. 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;
5. Regular use of high doses of vitamin E or C;
6. Use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutraceuticals;
7. Regular use of fiber supplements;
8. Diabetes;
9. Sleep apnea;
10. Restricted diets by choice (i.e., vegetarian, vegan);
11. Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin.

Primary outcomes:
measure: Endothelial Function Flow mediated dilatation (FMD) as the percent change in brachial artery diameter from pre-cuff inflation to 60 seconds post-cuff release.
timeFrame: 6 weeks
Secondary outcomes:
measure: Fasting Lipid Panel - Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio
timeFrame: 6 weeks
measure: 3-Day Food Diary
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Derby
country: United States
facility: Griffin Hospital
state: Connecticut
Study officials:
affiliation: Yale-Griffin Prevention Research Center
name: David L. Katz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.