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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
History of Changes
  Purpose

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).


Condition Intervention
Coronary Artery Disease
 Dietary Supplement: Egg supplementation
Dietary Supplement: Egg substitute
Dietary Supplement: Control diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease: A Randomized, Controlled, Crossover Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Griffin Hospital:

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. [ 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: October 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Egg supplementation
Daily consumption of 2 eggs for breakfast for 6 weeks
 Dietary Supplement: Egg supplementation
Daily consumption of 2 eggs for breakfast for 6 weeks
Experimental: Egg substitute
Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
 Dietary Supplement: Egg substitute
Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
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
 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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672567

Locations
United States, Connecticut
Griffin Hospital
Derby, Connecticut, United States, 06418
Sponsors and Collaborators
Griffin Hospital
American Egg Board
Investigators
Principal Investigator: David L. Katz, MD, MPH Yale-Griffin Prevention Research Center
  More Information

No publications provided

Responsible Party: Griffin Hospital
ClinicalTrials.gov Identifier: NCT01672567     History of Changes
Other Study ID Numbers: 2010/05
Study First Received: August 9, 2011
Last Updated: August 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Griffin Hospital:
Coronary Artery Disease
Egg Consumption
Endothelial Function

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013