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| Name | Class |
|---|---|
| American Egg Board | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egg supplementation | Experimental | Daily consumption of 2 eggs for breakfast for 6 weeks |
|
| Egg substitute | Experimental | Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks |
|
| Control diet | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Egg supplementation | Dietary Supplement | Daily consumption of 2 eggs for breakfast for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Function Flow mediated dilatation (FMD) as the percent change in brachial artery diameter from pre-cuff inflation to 60 seconds post-cuff release. | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Lipid Panel - Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio | Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L. Katz, MD, MPH | Yale-Griffin Prevention Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Griffin Hospital | Derby | Connecticut | 06418 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25497262 | Derived | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Egg substitute | Dietary Supplement | Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks |
|
| Control diet | Dietary Supplement | 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 |
|
| 3-Day Food Diary | 6 weeks |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |