<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01672567</url>
  </required_header>
  <id_info>
    <org_study_id>2010-05</org_study_id>
    <nct_id>NCT01672567</nct_id>
  </id_info>
  <brief_title>Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease</brief_title>
  <official_title>Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease: A Randomized, Controlled, Crossover Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Griffin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Egg Board</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Griffin Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effects of daily consumption of eggs or egg&#xD;
      substitute for 6 weeks on endothelial function and on cholesterol and lipoprotein levels in&#xD;
      participants with clinically established coronary heart disease (CHD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Restriction of dietary cholesterol, and thus the avoidance or restriction of egg intake, is&#xD;
      routinely recommended to patients with coronary disease. However, the relative importance of&#xD;
      dietary cholesterol to serum lipids has become a subject of active debate. Eggs provide a&#xD;
      complete array of amino acids and an array of micronutrients, and are low in total fat.&#xD;
      Epidemiological and clinical studies have showed that dietary intake of omega-3 fatty acids&#xD;
      decreases the risk of coronary heart disease (CHD). Endothelial function testing represents a&#xD;
      uniquely valuable means of assessing aggregated influences on cardiac risk by gauging&#xD;
      physiologic responses of the vascular endothelium. In prior studies the investigators have&#xD;
      shown that daily egg ingestion for 6 weeks did not adversely affect endothelial function in&#xD;
      healthy adults or in hyperlipidemic adults. The investigators now propose a prospective,&#xD;
      randomized, single-blind crossover study to assess the effects of eggs, egg substitute and&#xD;
      high-carbohydrate American breakfast on endothelial responses and serum lipids in&#xD;
      participants with clinically established CHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <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.</measure>
    <time_frame>6 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting Lipid Panel - Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio</measure>
    <time_frame>6 weeks</time_frame>
    <description>Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Day Food Diary</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Egg supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily consumption of 2 eggs for breakfast for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Egg substitute</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Egg supplementation</intervention_name>
    <description>Daily consumption of 2 eggs for breakfast for 6 weeks</description>
    <arm_group_label>Egg supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Egg substitute</intervention_name>
    <description>Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks</description>
    <arm_group_label>Egg substitute</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control diet</intervention_name>
    <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</description>
    <arm_group_label>Control diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males age greater than 35 years;&#xD;
&#xD;
          2. Post-menopausal females not currently on hormone replacement therapy;&#xD;
&#xD;
          3. Non-smokers;&#xD;
&#xD;
          4. CVD as defined by the presence of at least one coronary stenosis &gt;50% determined&#xD;
             angiographically or a documented history of myocardial infarction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Failure to meet inclusion criteria;&#xD;
&#xD;
          2. Anticipated inability to complete study protocol for any reason;&#xD;
&#xD;
          3. Current eating disorder;&#xD;
&#xD;
          4. Use of lipid-lowering or antihypertensive medications unless stable on medication for&#xD;
             at least 3 months and willing to refrain from taking medication for 12 hours prior to&#xD;
             EF scanning;&#xD;
&#xD;
          5. Regular use of high doses of vitamin E or C;&#xD;
&#xD;
          6. Use of insulin, glucose-sensitizing medication, vasoactive medication (including&#xD;
             glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or&#xD;
             nutraceuticals;&#xD;
&#xD;
          7. Regular use of fiber supplements;&#xD;
&#xD;
          8. Diabetes;&#xD;
&#xD;
          9. Sleep apnea;&#xD;
&#xD;
         10. Restricted diets by choice (i.e., vegetarian, vegan);&#xD;
&#xD;
         11. Coagulopathy, known bleeding diathesis, or history of clinically significant&#xD;
             hemorrhage; current use of warfarin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David L. Katz, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale-Griffin Prevention Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Griffin Hospital</name>
      <address>
        <city>Derby</city>
        <state>Connecticut</state>
        <zip>06418</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 9, 2011</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Egg Consumption</keyword>
  <keyword>Endothelial Function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672567
org study id: 2010-05
nct id: NCT01672567
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Investigator)
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
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.
measure: 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
description: Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, cholesterol / high density lipoprotein cholesterol ratio
measure: 3-Day Food Diary
time frame: 6 weeks
arm group label: Egg supplementation
arm group type: Experimental
description: Daily consumption of 2 eggs for breakfast for 6 weeks
arm group label: Egg substitute
arm group type: Experimental
description: Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
arm group label: Control diet
arm group type: Experimental
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: Egg supplementation
description: Daily consumption of 2 eggs for breakfast for 6 weeks
arm group label: Egg supplementation
intervention type: Dietary Supplement
intervention name: Egg substitute
description: Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
arm group label: Egg substitute
intervention type: Dietary Supplement
intervention name: 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
arm group label: Control diet
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
last name: David L. Katz, MD, MPH
role: Principal Investigator
affiliation: Yale-Griffin Prevention Research Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease