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

Griffin Hospital

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Dietary Supplement: Egg substitute; Dietary Supplement: Control diet; Dietary Supplement: Egg supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01672567

2010-05

Details and patient eligibility

About

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).

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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34 participants in 3 patient groups

Egg supplementation

Experimental group

Description:

Daily consumption of 2 eggs for breakfast for 6 weeks

Treatment:

Dietary Supplement: Egg supplementation

Egg substitute

Experimental group

Description:

Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks

Treatment:

Dietary Supplement: Egg substitute

Control diet

Experimental group

Description:

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

Treatment:

Dietary Supplement: Control diet