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Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease
This study has been completed.
Sponsor:
Griffin Hospital
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
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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 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:
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 ]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 ]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 ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01672567
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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 July 25, 2017