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

This study has been completed.
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Griffin Hospital
ClinicalTrials.gov Identifier:
NCT01672567
First received: August 9, 2011
Last updated: August 22, 2012
Last verified: August 2012

August 9, 2011
August 22, 2012
October 2010
April 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01672567 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio
  • 3-Day Food Diary [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease
Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease: A Randomized, Controlled, Crossover Trial

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Coronary Artery Disease
  • Dietary Supplement: Egg supplementation
    Daily consumption of 2 eggs for breakfast for 6 weeks
  • Dietary Supplement: Egg substitute
    Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
  • 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
  • Experimental: Egg supplementation
    Daily consumption of 2 eggs for breakfast for 6 weeks
    Intervention: Dietary Supplement: Egg supplementation
  • Experimental: Egg substitute
    Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
    Intervention: Dietary Supplement: Egg substitute
  • Experimental: 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: Dietary Supplement: Control diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01672567
2010/05
No
Griffin Hospital
Griffin Hospital
American Egg Board
Principal Investigator: David L. Katz, MD, MPH Yale-Griffin Prevention Research Center
Griffin Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP