Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Egg supplementation
Egg substitute
Control diet
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Egg Consumption, Endothelial Function
Eligibility Criteria
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.
Sites / Locations
- Griffin Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Egg supplementation
Egg substitute
Control diet
Arm Description
Daily consumption of 2 eggs for breakfast for 6 weeks
Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
3-Day Food Diary
Full Information
NCT ID
NCT01672567
First Posted
August 9, 2011
Last Updated
March 25, 2020
Sponsor
Griffin Hospital
Collaborators
American Egg Board
1. Study Identification
Unique Protocol Identification Number
NCT01672567
Brief Title
Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease
Official Title
Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease: A Randomized, Controlled, Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Griffin Hospital
Collaborators
American Egg Board
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Egg Consumption, Endothelial Function
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Egg supplementation
Arm Type
Experimental
Arm Description
Daily consumption of 2 eggs for breakfast for 6 weeks
Arm Title
Egg substitute
Arm Type
Experimental
Arm Description
Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
Arm Title
Control diet
Arm Type
Experimental
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Egg supplementation
Intervention Description
Daily consumption of 2 eggs for breakfast for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Egg substitute
Intervention Description
Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Control diet
Intervention 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
Primary Outcome Measure Information:
Title
Endothelial Function Flow mediated dilatation (FMD) as the percent change in brachial artery diameter from pre-cuff inflation to 60 seconds post-cuff release.
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fasting Lipid Panel - Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio
Description
Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio
Time Frame
6 weeks
Title
3-Day Food Diary
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L. Katz, MD, MPH
Organizational Affiliation
Yale-Griffin Prevention Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Griffin Hospital
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25497262
Citation
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.
Results Reference
derived
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Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease
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