<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/NCT02223169</url>
  </required_header>
  <id_info>
    <org_study_id>ECFP7-312090</org_study_id>
    <nct_id>NCT02223169</nct_id>
  </id_info>
  <brief_title>Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk</brief_title>
  <acronym>CardiProtein</acronym>
  <official_title>Dietary Intervention Study to Assess the Effects of Albumin-Derived Peptides on Cardio-Metabolic Risk Factors in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College Cork</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College Cork</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heart disease and stroke are the most common cause of death in Ireland today.One of the main&#xD;
      risk factors for heart disease and stroke is high blood pressure or hypertension. Research&#xD;
      has found that certain specific proteins or peptides found in foods such as dairy, meat, fish&#xD;
      and eggs may promote heart health reducing blood pressure in adults with hypertension. The&#xD;
      aim of this study is to investigate the potential beneficial effects egg peptides may have on&#xD;
      heart health, in particular, effects on blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Poor dietary habits of Irish adults has been accompanied by epidemics of obesity and&#xD;
      metabolic disorders such as type II diabetes leading to a substantial predicted increase in&#xD;
      the prevalence of chronic diseases such as cardiovascular disease.Hypertension is a major&#xD;
      contributing factor to the development of cardiovascular and metabolic diseases. Dietary&#xD;
      factors play a significant role in the prevention and/or treatment of hypertension and&#xD;
      therefore the development of foods with antihypertensive properties could prove beneficial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group.</measure>
    <time_frame>42 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Egg albumin-derived peptide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will consume 1 sachet of Egg albumin-derived peptide (3 g) each day mixed with a fruit juice drink for 42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will consume one sachet of the placebo mixed with a fruit juice drink that will appear and taste similar to the albumin derived peptide sachet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Egg albumin-derived peptide</intervention_name>
    <description>Double-blind intervention study cross-over design with one sachet containing 3g Egg albumin-derived peptide (Tensio-control) or placebo (maltodextrin) in Phase one followed by cross-over in Phase 2.</description>
    <arm_group_label>Egg albumin-derived peptide</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Tensio-control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female&#xD;
&#xD;
          -  Non-diabetic&#xD;
&#xD;
          -  Aged 50-65&#xD;
&#xD;
          -  BMI 25-35kg/m²&#xD;
&#xD;
          -  Mild hypertensive: Blood pressure 130-149 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Diagnosed hypertensive&#xD;
&#xD;
          -  History of cardiovascular disease&#xD;
&#xD;
          -  Diabetic&#xD;
&#xD;
          -  Chronic kidney disease&#xD;
&#xD;
          -  Gastrointestinal disease&#xD;
&#xD;
          -  Currently on anti-hypertensive medications&#xD;
&#xD;
          -  Allergic to eggs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mairead Kiely, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College Cork</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Food and Nutritional Sciences, UCC</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Cork</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>May 2, 2017</last_update_submitted>
  <last_update_submitted_qc>May 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College Cork</investigator_affiliation>
    <investigator_full_name>Mairead Kiely PhD</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Blood Pressure</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Cardiovascular disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT02223169
org study id: ECFP7-312090
nct id: NCT02223169
lead sponsor: 
has dmc: Yes
Heart disease and stroke are the most common cause of death in Ireland today.One of the main
      risk factors for heart disease and stroke is high blood pressure or hypertension. Research
      has found that certain specific proteins or peptides found in foods such as dairy, meat, fish
      and eggs may promote heart health reducing blood pressure in adults with hypertension. The
      aim of this study is to investigate the potential beneficial effects egg peptides may have on
      heart health, in particular, effects on blood pressure.
Poor dietary habits of Irish adults has been accompanied by epidemics of obesity and
      metabolic disorders such as type II diabetes leading to a substantial predicted increase in
      the prevalence of chronic diseases such as cardiovascular disease.Hypertension is a major
      contributing factor to the development of cardiovascular and metabolic diseases. Dietary
      factors play a significant role in the prevention and/or treatment of hypertension and
      therefore the development of foods with antihypertensive properties could prove beneficial.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group.
time frame: 42 days
arm group label: Egg albumin-derived peptide
arm group type: Experimental
description: Each participant will consume 1 sachet of Egg albumin-derived peptide (3 g) each day mixed with a fruit juice drink for 42 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will consume one sachet of the placebo mixed with a fruit juice drink that will appear and taste similar to the albumin derived peptide sachet.
intervention type: Dietary Supplement
intervention name: Egg albumin-derived peptide
description: Double-blind intervention study cross-over design with one sachet containing 3g Egg albumin-derived peptide (Tensio-control) or placebo (maltodextrin) in Phase one followed by cross-over in Phase 2.
arm group label: Egg albumin-derived peptide
arm group label: Placebo
other name: Tensio-control
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mairead Kiely, PhD
role: Principal Investigator
affiliation: University College Cork
facility: 
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: University College Cork
investigator full name: Mairead Kiely PhD
investigator title: Dr
mesh term: Hypertension