<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/NCT03272074</url>
  </required_header>
  <id_info>
    <org_study_id>2015.15638</org_study_id>
    <nct_id>NCT03272074</nct_id>
  </id_info>
  <brief_title>Egg Consumption and Glycemic Control in Individuals With Pre- and Type II-diabetes</brief_title>
  <official_title>Egg Consumption Positively Affects Glycemic Control and Insulin Sensitivity in Individuals With Pre- and Type II-diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Egg Nutrition Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The intent of this study is to examine the extent to which daily incorporation of egg into a&#xD;
      diet improves glycemic control, insulin sensitivity, lipid profiles, and body composition in&#xD;
      overweight and obese adults with pre- and type II-diabetes. The hypothesis of this study is&#xD;
      that the daily incorporation of one large egg into a diet for 12 weeks will exert positive&#xD;
      effects on factors associated with glycemic control and insulin sensitivity in overweight and&#xD;
      obese adults with pre- and type II-diabetes through improvements in body weight, body&#xD;
      composition, and lipid metabolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-diabetes is a condition that is characterized by elevated fasting blood glucose levels&#xD;
      secondary to insulin resistance; however, fasting blood glucose levels are not elevated to&#xD;
      the extent where it can be classified as type II-diabetes. Pre-diabetes may lead to type&#xD;
      II-diabetes and is estimated to do so at an annual rate of approximately 10% in the United&#xD;
      States (US) where approximately 79 million individuals have been diagnosed with pre-diabetes.&#xD;
      In addition, most of the individuals presenting with pre-diabetes are overweight or obese,&#xD;
      which makes long-term weight management an essential component in reducing the development of&#xD;
      diabetes. Eggs are a rich source of important nutrients such as vitamins, minerals, proteins,&#xD;
      carotenoids, choline, and lecithin. Many of the nutrients found in eggs function as&#xD;
      antioxidants or as an essential component of antioxidants. Several studies have demonstrated&#xD;
      that the onset and progression of diabetes are associated with increased oxidative stress. In&#xD;
      vitro studies have shown that high-density lipoprotein (HDL) acts as a buffer mechanism for&#xD;
      oxidative stress and inflammation due to its antioxidant effects. Thus, high blood levels of&#xD;
      HDL may reduce insulin resistance and subsequently the development of type II-diabetes&#xD;
      through its antioxidant and anti-inflammatory effects. Additionally, HDL can exert beneficial&#xD;
      effects on glucose levels through the apolipoprotein A-1 (Apo A) action which increases&#xD;
      glucose uptake by increasing insulin secretion in pancreatic beta cells. Because the&#xD;
      development of diabetes involves an interaction between genetic predisposition and&#xD;
      environmental factors including and excessive body weight, and eggs have been shown to&#xD;
      positively influence body composition, we believe that eggs can improve glycemic control,&#xD;
      insulin sensitivity, and lipid profiles through improvements in weight and body composition.&#xD;
      To our knowledge, there have not been any studies investigating the effects of dietary egg&#xD;
      consumption on improving glycemic control, insulin sensitivity, lipid profiles, and body&#xD;
      composition in overweight and obese adults with pre- and type II-diabetics. Our long-term&#xD;
      goal is to bring forth evidence that the regular consumption of eggs is effective in reducing&#xD;
      insulin resistance and subsequently the incidence of pre-diabetes and type II-diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2015</start_date>
  <completion_date type="Actual">August 5, 2017</completion_date>
  <primary_completion_date type="Actual">September 7, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting blood glucose, insulin resistance, and insulin sensitivity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Commercially available enzyme-linked immunosorbent assay (ELISA) kits will be used to measure fasting blood glucose levels (mg/dL.). Insulin levels will be measured using a commercially available ELISA kit (mg/dL). blood glucose and insulin level measurements will be used to calculate Insulin sensitivity and insulin resistance will be measured using HOMA-IR and HOMA-β using the HOMA2 Calculator v2.2.2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipid panel</measure>
    <time_frame>12 weeks</time_frame>
    <description>ELISA kits will be used to measure the lipid panel parameters (mg/dL)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body composition</measure>
    <time_frame>12 weeks</time_frame>
    <description>A certified operator will obtain DXA scans of each subject using DXA (GE Healthcare Lunar, Madison, WI, U.S.).</description>
  </other_outcome>
  <other_outcome>
    <measure>ABCA1 Protein</measure>
    <time_frame>12 weeks</time_frame>
    <description>ELISA kits will be used to measure the ABCA1 protein (mg/dL)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Obesity</condition>
  <condition>Pre Diabetes</condition>
  <arm_group>
    <arm_group_label>Egg Group (Group A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will consume one large egg per day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Egg White Group (Group B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will consume equivalent amounts of egg whites for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Egg and egg white</intervention_name>
    <description>Participants will consume either one large eggs or equivalent amount of egg white (3/4 cups) for 12 weeks. Participants will maintain their regular diet and physical activities.</description>
    <arm_group_label>Egg Group (Group A)</arm_group_label>
    <arm_group_label>Egg White Group (Group B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight and obese, BMI is between 25 kg/m2 and 45 kg/m2&#xD;
&#xD;
          -  With pre- and type II-diabetes. Subjects will be eligible if their Hgb A1c level is&#xD;
             &gt;5.6%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with BMI≤ 24 or ≥46 kg/m2&#xD;
&#xD;
          -  Uncontrolled hypertension (≥160/100 mmHg), active cancer, asthma, thyroid, glaucoma,&#xD;
             kidney, liver and pancreatic diseases will be excluded from the study.&#xD;
&#xD;
          -  Subjects who are participating in any weight loss program and/or are heavy smokers&#xD;
             (more than 20 cigarettes per day) will be excluded from the study.&#xD;
&#xD;
          -  Subjects who are allergic to egg and egg products will also be excluded from the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shirin Pourafshar, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Florida State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida State University</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Bahram Arjmandi</investigator_full_name>
    <investigator_title>Margaret A. Sitton Professor, Director of Center for Advancing Exercise and Nutrition Research on Aging</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03272074
org study id: 2015.15638
nct id: NCT03272074
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The intent of this study is to examine the extent to which daily incorporation of egg into a
      diet improves glycemic control, insulin sensitivity, lipid profiles, and body composition in
      overweight and obese adults with pre- and type II-diabetes. The hypothesis of this study is
      that the daily incorporation of one large egg into a diet for 12 weeks will exert positive
      effects on factors associated with glycemic control and insulin sensitivity in overweight and
      obese adults with pre- and type II-diabetes through improvements in body weight, body
      composition, and lipid metabolism.
Pre-diabetes is a condition that is characterized by elevated fasting blood glucose levels
      secondary to insulin resistance; however, fasting blood glucose levels are not elevated to
      the extent where it can be classified as type II-diabetes. Pre-diabetes may lead to type
      II-diabetes and is estimated to do so at an annual rate of approximately 10% in the United
      States (US) where approximately 79 million individuals have been diagnosed with pre-diabetes.
      In addition, most of the individuals presenting with pre-diabetes are overweight or obese,
      which makes long-term weight management an essential component in reducing the development of
      diabetes. Eggs are a rich source of important nutrients such as vitamins, minerals, proteins,
      carotenoids, choline, and lecithin. Many of the nutrients found in eggs function as
      antioxidants or as an essential component of antioxidants. Several studies have demonstrated
      that the onset and progression of diabetes are associated with increased oxidative stress. In
      vitro studies have shown that high-density lipoprotein (HDL) acts as a buffer mechanism for
      oxidative stress and inflammation due to its antioxidant effects. Thus, high blood levels of
      HDL may reduce insulin resistance and subsequently the development of type II-diabetes
      through its antioxidant and anti-inflammatory effects. Additionally, HDL can exert beneficial
      effects on glucose levels through the apolipoprotein A-1 (Apo A) action which increases
      glucose uptake by increasing insulin secretion in pancreatic beta cells. Because the
      development of diabetes involves an interaction between genetic predisposition and
      environmental factors including and excessive body weight, and eggs have been shown to
      positively influence body composition, we believe that eggs can improve glycemic control,
      insulin sensitivity, and lipid profiles through improvements in weight and body composition.
      To our knowledge, there have not been any studies investigating the effects of dietary egg
      consumption on improving glycemic control, insulin sensitivity, lipid profiles, and body
      composition in overweight and obese adults with pre- and type II-diabetics. Our long-term
      goal is to bring forth evidence that the regular consumption of eggs is effective in reducing
      insulin resistance and subsequently the incidence of pre-diabetes and type II-diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Fasting blood glucose, insulin resistance, and insulin sensitivity
time frame: 12 weeks
description: Commercially available enzyme-linked immunosorbent assay (ELISA) kits will be used to measure fasting blood glucose levels (mg/dL.). Insulin levels will be measured using a commercially available ELISA kit (mg/dL). blood glucose and insulin level measurements will be used to calculate Insulin sensitivity and insulin resistance will be measured using HOMA-IR and HOMA-β using the HOMA2 Calculator v2.2.2
measure: Lipid panel
time frame: 12 weeks
description: ELISA kits will be used to measure the lipid panel parameters (mg/dL)
measure: Body composition
time frame: 12 weeks
description: A certified operator will obtain DXA scans of each subject using DXA (GE Healthcare Lunar, Madison, WI, U.S.).
measure: ABCA1 Protein
time frame: 12 weeks
description: ELISA kits will be used to measure the ABCA1 protein (mg/dL)
arm group label: Egg Group (Group A)
arm group type: Experimental
description: Participants will consume one large egg per day for 12 weeks
arm group label: Egg White Group (Group B)
arm group type: Active Comparator
description: Participants will consume equivalent amounts of egg whites for 12 weeks
intervention type: Other
intervention name: Egg and egg white
description: Participants will consume either one large eggs or equivalent amount of egg white (3/4 cups) for 12 weeks. Participants will maintain their regular diet and physical activities.
arm group label: Egg Group (Group A)
arm group label: Egg White Group (Group B)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Shirin Pourafshar, PhD
role: Study Director
affiliation: Florida State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Bahram Arjmandi
investigator title: Margaret A. Sitton Professor, Director of Center for Advancing Exercise and Nutrition Research on Aging
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State
sharing ipd: No