Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-04-24 @ 2:58 AM
Study NCT ID:
NCT01672567
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2011-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2012-08-22', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '6 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Fasting Lipid Panel - Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio', 'timeFrame': '6 weeks', 'description': 'Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio'}, {'measure': '3-Day Food Diary', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Egg Consumption', 'Endothelial Function'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '25497262', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males age greater than 35 years;\n2. Post-menopausal females not currently on hormone replacement therapy;\n3. Non-smokers;\n4. CVD as defined by the presence of at least one coronary stenosis \\>50% determined angiographically or a documented history of myocardial infarction.\n\nExclusion Criteria:\n\n1. Failure to meet inclusion criteria;\n2. Anticipated inability to complete study protocol for any reason;\n3. Current eating disorder;\n4. 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;\n5. Regular use of high doses of vitamin E or C;\n6. Use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutraceuticals;\n7. Regular use of fiber supplements;\n8. Diabetes;\n9. Sleep apnea;\n10. Restricted diets by choice (i.e., vegetarian, vegan);\n11. Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin.'}, 'identificationModule': {'nctId': 'NCT01672567', 'briefTitle': 'Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Griffin Hospital'}, 'officialTitle': 'Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease: A Randomized, Controlled, Crossover Trial', 'orgStudyIdInfo': {'id': '2010-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Egg supplementation', 'description': 'Daily consumption of 2 eggs for breakfast for 6 weeks', 'interventionNames': ['Dietary Supplement: Egg supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Egg substitute', 'description': 'Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks', 'interventionNames': ['Dietary Supplement: Egg substitute']}, {'type': 'EXPERIMENTAL', 'label': 'Control diet', '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', 'interventionNames': ['Dietary Supplement: Control diet']}], 'interventions': [{'name': 'Egg supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily consumption of 2 eggs for breakfast for 6 weeks', 'armGroupLabels': ['Egg supplementation']}, {'name': 'Egg substitute', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks', 'armGroupLabels': ['Egg substitute']}, {'name': 'Control diet', 'type': 'DIETARY_SUPPLEMENT', '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', 'armGroupLabels': ['Control diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06418', 'city': 'Derby', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Griffin Hospital', 'geoPoint': {'lat': 41.32065, 'lon': -73.089}}], 'overallOfficials': [{'name': 'David L. Katz, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale-Griffin Prevention Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Griffin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Egg Board', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}