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

NCT ID: NCT01672567

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Egg supplementation

Daily consumption of 2 eggs for breakfast for 6 weeks

Group Type EXPERIMENTAL

Egg supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Egg substitute

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Control diet

Intervention Type 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

Interventions

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Egg supplementation

Daily consumption of 2 eggs for breakfast for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Egg substitute

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Egg Board

OTHER

Sponsor Role collaborator

Griffin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David L. Katz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale-Griffin Prevention Research Center

Locations

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Griffin Hospital

Derby, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25497262 (View on PubMed)

Other Identifiers

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2010-05

Identifier Type: -

Identifier Source: org_study_id

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