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Completed

NCT Number: NCT01672567

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

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).

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Griffin Hospital

Derby, Connecticut, 06418, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Egg Supplementation

Dietary Supplement

Daily consumption of 2 eggs for breakfast for 6 weeks

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

Primary outcomes

  1. Endothelial Function Flow mediated dilatation (FMD) as the percent change in brachial artery diameter from pre-cuff inflation to 60 seconds post-cuff release.

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Fasting Lipid Panel - Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio

    Time frame: 6 weeks

    Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio

  2. 3-Day Food Diary

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Griffin Hospital

Other

Collaborators

  • American Egg Board

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2012
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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