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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672567
• Other study ID #: 2010-05
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: March 2020
• Source: Griffin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Griffin Hospital	Derby	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Griffin Hospital	American Egg Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	3-Day Food Diary		6 weeks