<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/NCT04496817</url>
  </required_header>
  <id_info>
    <org_study_id>B2020:007</org_study_id>
    <nct_id>NCT04496817</nct_id>
  </id_info>
  <brief_title>Enriched Eggs for Retina Health in Type 2 Diabetes</brief_title>
  <official_title>Effects of DHA and Lutein Enriched Eggs on Retina Health and Metabolic and Physical Parameters in Type 2 Diabetes: a Strategy for Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Egg Farmers of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes mellitus has been declared a major public health issue. Among the complications of&#xD;
      the disease, retinopathy can have a significant impact on mobility and quality of life for&#xD;
      individuals living with diabetes. As the leading cause of new blindness in adults, diabetic&#xD;
      retinopathy has been shown to affect 23% of all Type 1 and 14% of Type 2 diabetic&#xD;
      individuals. Various studies have reported that a number of components in the egg may&#xD;
      contribute to visual function and eye health. Specifically, i) egg yolk naturally contains,&#xD;
      and can be further enriched with the carotenoids lutein and zeaxanthin. Lutein and zeaxanthin&#xD;
      protect the retina against light induced retinal damage by acting as potent antioxidants that&#xD;
      shield the retina from harmful short-wave radiation. ii) eggs can also be enriched to provide&#xD;
      a vehicle for specific nutrients to promote eye health including omega-3 fatty acid,&#xD;
      docosahexaenoic acid (DHA). A substantial amount of DHA is uniquely found within the retina.&#xD;
      A DHA deficiency has shown to induce abnormal retina function indicating a constant supply of&#xD;
      this nutrient is necessary for retina health. Currently, the American Diabetes Association&#xD;
      declares that eggs are an excellent choice for people with diabetes, but information lacks on&#xD;
      the status of whole egg consumption in diabetic individuals in relation to their retinal&#xD;
      health. Therefore, the current study aims to determine if the consumption of two lutein and&#xD;
      DHA enriched eggs per day can safely improve the retina function of individuals with type 2&#xD;
      diabetes.&#xD;
&#xD;
      A total of 60 adult diabetic male and female participants will be recruited to take part in&#xD;
      this double-blinded, randomized, placebo-controlled, parallel trial. Participants will be&#xD;
      randomly assigned to include two DHA and lutein enriched eggs or regular eggs into their&#xD;
      usual diet for 6 weeks. At the beginning and end of the trial, a variety of measures will be&#xD;
      analyzed including blood lipid parameters, carotenoid status, anthropometrics, arterial&#xD;
      stiffness, advanced glycated end products, macular pigment optical density and&#xD;
      electroretinography. These measures will aid in determining whether enriched egg consumption&#xD;
      can safely improve retina function, while not adversely effecting body composition and&#xD;
      cardiovascular risk factors in individuals with diabetes. The results of this study will&#xD;
      contribute to the development of valuable prevention strategies for eye health in individuals&#xD;
      with diabetes, thereby improving their quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 11, 2022</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Double-blinded, randomized, placebo-controlled, parallel trial.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Retina Function</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measured by Full Field Electroretinography</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Enriched Egg Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will consume 2 medium sized docosahexaenoic acid and lutein enriched eggs daily (at least 5 days per week) for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular Egg Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will consume 2 medium sized non-enriched eggs daily (at least 5 days per week) for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Docosahexaenoic Acid and Lutein Enriched Eggs</intervention_name>
    <description>Consumption of 2 docosahexaenoic acid and lutein enriched eggs daily (at least 5 days our week) for 6 weeks</description>
    <arm_group_label>Enriched Egg Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regular Eggs</intervention_name>
    <description>Consumption of 2 non enriched eggs daily (at least 5 days our week) for 6 weeks</description>
    <arm_group_label>Regular Egg Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (&gt;19 years of age)&#xD;
&#xD;
          -  Individuals diagnosed with Type 2 diabetes&#xD;
&#xD;
          -  Individuals taking oral hypoglycemic medications (sulfonylureas, meglitinides,&#xD;
             biguanides, thiazolidinediones etc.)&#xD;
&#xD;
          -  Individuals with a fasting plasma glucose of ≥7.0 mmol/L or glycated hemoglobin (A1C)&#xD;
             of ≥6.5%. (these values are based on the Canadian Diabetes Association and are&#xD;
             predictors of the development of diabetic retinopathy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals previously diagnosed with moderate to severe diabetic retinopathy (to&#xD;
             assess egg consumption as a preventative strategy for diabetic retinopathy).&#xD;
&#xD;
          -  Individuals with eye disease (cataracts, glaucoma, age-related macular degeneration,&#xD;
             retinitis pigmentosa, optic atrophy, and eye malformation etc.)&#xD;
&#xD;
          -  Individuals with Alzheimer's, dementia or other mental cognitive diseases&#xD;
&#xD;
          -  Individuals with Type 1 diabetes&#xD;
&#xD;
          -  Individuals taking insulin&#xD;
&#xD;
          -  Individuals diagnosed with cancer or anemia&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miyoung Suh, RD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Miyoung Suh, RD, PhD</last_name>
    <phone>204-235-3106</phone>
    <email>miyoung.suh@umanitoba.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chelsey Walchuk, RD, MSc</last_name>
    <phone>204-235-2573</phone>
    <email>umwalchu@myumanitoba.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Asper Clinical Research Institute</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2H 2A6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaime Clark, PhD</last_name>
      <phone>204-25-1351</phone>
      <email>jclark@sbrc.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04496817
org study id: B2020:007
nct id: NCT04496817
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diabetes mellitus has been declared a major public health issue. Among the complications of
      the disease, retinopathy can have a significant impact on mobility and quality of life for
      individuals living with diabetes. As the leading cause of new blindness in adults, diabetic
      retinopathy has been shown to affect 23% of all Type 1 and 14% of Type 2 diabetic
      individuals. Various studies have reported that a number of components in the egg may
      contribute to visual function and eye health. Specifically, i) egg yolk naturally contains,
      and can be further enriched with the carotenoids lutein and zeaxanthin. Lutein and zeaxanthin
      protect the retina against light induced retinal damage by acting as potent antioxidants that
      shield the retina from harmful short-wave radiation. ii) eggs can also be enriched to provide
      a vehicle for specific nutrients to promote eye health including omega-3 fatty acid,
      docosahexaenoic acid (DHA). A substantial amount of DHA is uniquely found within the retina.
      A DHA deficiency has shown to induce abnormal retina function indicating a constant supply of
      this nutrient is necessary for retina health. Currently, the American Diabetes Association
      declares that eggs are an excellent choice for people with diabetes, but information lacks on
      the status of whole egg consumption in diabetic individuals in relation to their retinal
      health. Therefore, the current study aims to determine if the consumption of two lutein and
      DHA enriched eggs per day can safely improve the retina function of individuals with type 2
      diabetes.

      A total of 60 adult diabetic male and female participants will be recruited to take part in
      this double-blinded, randomized, placebo-controlled, parallel trial. Participants will be
      randomly assigned to include two DHA and lutein enriched eggs or regular eggs into their
      usual diet for 6 weeks. At the beginning and end of the trial, a variety of measures will be
      analyzed including blood lipid parameters, carotenoid status, anthropometrics, arterial
      stiffness, advanced glycated end products, macular pigment optical density and
      electroretinography. These measures will aid in determining whether enriched egg consumption
      can safely improve retina function, while not adversely effecting body composition and
      cardiovascular risk factors in individuals with diabetes. The results of this study will
      contribute to the development of valuable prevention strategies for eye health in individuals
      with diabetes, thereby improving their quality of life.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blinded, randomized, placebo-controlled, parallel trial.
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change in Retina Function
time frame: 6 weeks
description: Measured by Full Field Electroretinography
arm group label: Enriched Egg Group
arm group type: Experimental
description: Participants will consume 2 medium sized docosahexaenoic acid and lutein enriched eggs daily (at least 5 days per week) for 6 weeks.
arm group label: Regular Egg Group
arm group type: Placebo Comparator
description: Participants will consume 2 medium sized non-enriched eggs daily (at least 5 days per week) for 6 weeks.
intervention type: Other
intervention name: Docosahexaenoic Acid and Lutein Enriched Eggs
description: Consumption of 2 docosahexaenoic acid and lutein enriched eggs daily (at least 5 days our week) for 6 weeks
arm group label: Enriched Egg Group
intervention type: Other
intervention name: Regular Eggs
description: Consumption of 2 non enriched eggs daily (at least 5 days our week) for 6 weeks
arm group label: Regular Egg Group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Miyoung Suh, RD, PhD
role: Principal Investigator
affiliation: University of Manitoba
last name: Miyoung Suh, RD, PhD
phone: 204-235-3106
email: miyoung.suh@umanitoba.ca
last name: Chelsey Walchuk, RD, MSc
phone: 204-235-2573
email: umwalchu@myumanitoba.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2