<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/NCT03771261</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00089075</org_study_id>
    <nct_id>NCT03771261</nct_id>
  </id_info>
  <brief_title>Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race</brief_title>
  <acronym>EGGSPDITe</acronym>
  <official_title>Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Egg Nutrition Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke 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 purpose of the trial is to assess the effects of combining regular, generous intakes of&#xD;
      high quality protein (with substantial amounts provided from whole eggs and egg whites) with&#xD;
      calorie restriction on insulin resistance and weight loss (along with function, body&#xD;
      composition, racial disparities, and a number of secondary outcomes) in black and white older&#xD;
      adults with prediabetes who are participating in a 4-month intervention. The investigators&#xD;
      will compare these effects to the same outcomes with a control group consuming a traditional&#xD;
      control regimen of calorie restriction over the same duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Older (&gt;60 yrs) men and women (50% African American, 50% white) who are obese (BMI &gt;30 kg/m2)&#xD;
      and have pre-diabetes will be randomly assigned (1:1 ratio; couples randomized together) to&#xD;
      one to two treatment groups: 1) Weight loss intervention (WL-Control; n = 20): subjects&#xD;
      follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d; and 2) High&#xD;
      protein weight loss intervention (WL-Protein; n = 20): subjects follow a calorie-reduction&#xD;
      diet for a weight loss of ≥10%, with a high proportion of high quality protein (&gt; 30g&#xD;
      protein, 3/day, 60-70% egg protein). Primary (insulin resistance/sensitivity, weight loss)&#xD;
      and secondary outcomes (physical function, body composition, diet adherence, cognitive&#xD;
      function, readiness to change) will be measured at 0 and 4 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2018</start_date>
  <completion_date type="Actual">November 8, 2021</completion_date>
  <primary_completion_date type="Actual">November 5, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Insulin Resistance at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Blood glucose and insulin levels in whole blood will be used to compute HOMA-IR (= glucose mg/dL x insulin mg/dL/405)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Body weight at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Weight loss as measured in light clothing on a dedicated scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Short Physical Performance Battery at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Physical Performance as measured by Short Physical Performance Battery (SPPB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline 6-minute walk (meters) at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Distance (meters) walked in 6 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline 8-foot up and Go time at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Time it takes to get up from a chair walk around a cone and sit back down (8-foot up and go)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline 30-second chair stands (number of stands) at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>the number of chair stands completed in 30 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline handgrip strength at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>the highest weight achieved from 2 attempts using the JAMAR dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline grooved pegboard time at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>measure of hand dexterity, time it takes to fit pegs into grooved pegboard</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline fat mass (%) at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Body fat mass (%) as measured by Bodpod</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline fat mass (kgs) at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Body fat mass (kg) as measured by Bodpod</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline lean mass (kgs) at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Body lean mass (kg) as measured by Bodpod</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline lean mass (%) at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Body lean mass (%) as measured by Bodpod</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline minimal waist circumference at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Body proportions will be measured at the minimal waist using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are &gt; 0.5 cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline umbilical waist circumference at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Body proportions will be measured at the umbilical waist using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are &gt; 0.5 cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline hip circumference at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Body proportions will be measured at the hip using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are &gt; 0.5 cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline total calories at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline macronutrient intake at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Macronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline micronutrient intake at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Micronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Symbol digit modalities test at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Symbol Digit Modalities Test measures cognitive impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Trail Making Test at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Trail Making Test neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Hopkins Verbal Learning Test at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Hopkins Verbal Learning Test consists of three trials of free-recall of a 12-item, semantically categorized list, followed by yes/no recognition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Profile of Mood States at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from &quot;not at all&quot; to &quot;extremely&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Perceived Stress Scale at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>Perceived Stress Scale is a a 12-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Insulin Sensitivity at 4 months</measure>
    <time_frame>0 to 4 months</time_frame>
    <description>insulin sensitivity HOMA-β (= 360 x insulin mg/dL / glucose mg/dL - 63; %).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Pre Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>WL-Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Weight loss intervention (WL-Control; n = 20): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WL-Protein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High-protein weight loss intervention (WL-Protein; n = 20): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of &gt; 30g of protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal sources (high quality) and 60-70% of animal protein from eggs or egg protein powder that will be provided to WL-Protein participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight Loss</intervention_name>
    <description>Participants will be prescribed hypo-caloric diet by a registered dietitian and attend weekly social support/nutrition education meetings.</description>
    <arm_group_label>WL-Control</arm_group_label>
    <arm_group_label>WL-Protein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Egg Protein</intervention_name>
    <description>Participants will be provided pre-packaged hard-boiled eggs (3/day, medium) and egg white protein powder.</description>
    <arm_group_label>WL-Protein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 60 years&#xD;
&#xD;
          -  Identifies as Caucasian/white or African-American/black&#xD;
&#xD;
          -  Obese body weight (&gt;30 kg/m2)&#xD;
&#xD;
          -  Able to speak and understand spoken and written English&#xD;
&#xD;
          -  Elevated fasting plasma glucose (≥95 and &lt;126 mg/dL)&#xD;
&#xD;
          -  Age-normal Kidney function (≥ 45 mL/min/1.73 m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body weight &gt; 224 kg (limit of the BodPod)&#xD;
&#xD;
          -  Treated or untreated diabetes (prior diagnosis, treatment, or fasting blood glucose&#xD;
             ≥126 mg/dL)&#xD;
&#xD;
          -  Presence of unstable, acutely symptomatic, or life-limiting illness&#xD;
&#xD;
          -  Positive screen for dementia using Mini-Cog evaluation tool&#xD;
&#xD;
          -  Neurological conditions causing functional or cognitive impairments&#xD;
&#xD;
          -  History of significant weight instability (defined as &gt; 10 pounds weight gain or loss&#xD;
             over 6 months prior to study participation)&#xD;
&#xD;
          -  Allergy or intolerance to egg products&#xD;
&#xD;
          -  Unwillingness or inability to be randomized to any one of two intervention groups,&#xD;
             submit to all study testing, or continuously participate in a randomly assigned&#xD;
             lifestyle intervention program for four months&#xD;
&#xD;
          -  Inability to walk independently&#xD;
&#xD;
          -  Unable to give consent&#xD;
&#xD;
          -  Unable to complete written recording forms including journals of eating and exercise&#xD;
             behaviors.&#xD;
&#xD;
          -  Current use of the following medications: monoamine oxidase inhibitors, prescription&#xD;
             weight loss medications, insulin, metformin or any other hypoglycemic agent&#xD;
&#xD;
          -  Primary Care Physician advises against participation&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Unusually or unstable renal function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Connie Bales, RD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://medschool.duke.edu/</url>
    <description>Duke University School of Medicine</description>
  </link>
  <link>
    <url>https://www.eggnutritioncenter.org/</url>
    <description>Egg Nutrition Center</description>
  </link>
  <reference>
    <citation>Porter Starr KN, McDonald SR, Bales CW. Obesity and physical frailty in older adults: a scoping review of lifestyle intervention trials. J Am Med Dir Assoc. 2014 Apr;15(4):240-50. doi: 10.1016/j.jamda.2013.11.008. Epub 2014 Jan 17.</citation>
    <PMID>24445063</PMID>
  </reference>
  <reference>
    <citation>Porter Starr KN, Pieper CF, Orenduff MC, McDonald SR, McClure LB, Zhou R, Payne ME, Bales CW. Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1369-75. doi: 10.1093/gerona/glv210. Epub 2016 Jan 18.</citation>
    <PMID>26786203</PMID>
  </reference>
  <reference>
    <citation>Porter Starr KN, McDonald SR, Weidner JA, Bales CW. Challenges in the Management of Geriatric Obesity in High Risk Populations. Nutrients. 2016 May 4;8(5):262. doi: 10.3390/nu8050262.</citation>
    <PMID>27153084</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Egg</keyword>
  <keyword>Protein</keyword>
  <keyword>Aging</keyword>
  <keyword>Health Disparities</keyword>
  <keyword>Weight Loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Insulin Resistance</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/NCT03771261
org study id: Pro00089075
nct id: NCT03771261
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the trial is to assess the effects of combining regular, generous intakes of
      high quality protein (with substantial amounts provided from whole eggs and egg whites) with
      calorie restriction on insulin resistance and weight loss (along with function, body
      composition, racial disparities, and a number of secondary outcomes) in black and white older
      adults with prediabetes who are participating in a 4-month intervention. The investigators
      will compare these effects to the same outcomes with a control group consuming a traditional
      control regimen of calorie restriction over the same duration.
Older (>60 yrs) men and women (50% African American, 50% white) who are obese (BMI >30 kg/m2)
      and have pre-diabetes will be randomly assigned (1:1 ratio; couples randomized together) to
      one to two treatment groups: 1) Weight loss intervention (WL-Control; n = 20): subjects
      follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d; and 2) High
      protein weight loss intervention (WL-Protein; n = 20): subjects follow a calorie-reduction
      diet for a weight loss of ≥10%, with a high proportion of high quality protein (> 30g
      protein, 3/day, 60-70% egg protein). Primary (insulin resistance/sensitivity, weight loss)
      and secondary outcomes (physical function, body composition, diet adherence, cognitive
      function, readiness to change) will be measured at 0 and 4 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Insulin Resistance at 4 months
time frame: 0 to 4 months
description: Blood glucose and insulin levels in whole blood will be used to compute HOMA-IR (= glucose mg/dL x insulin mg/dL/405)
measure: Change from Baseline Body weight at 4 months
time frame: 0 to 4 months
description: Weight loss as measured in light clothing on a dedicated scale.
measure: Change from baseline Short Physical Performance Battery at 4 months
time frame: 0 to 4 months
description: Physical Performance as measured by Short Physical Performance Battery (SPPB)
measure: Change from baseline 6-minute walk (meters) at 4 months
time frame: 0 to 4 months
description: Distance (meters) walked in 6 minutes
measure: Change from baseline 8-foot up and Go time at 4 months
time frame: 0 to 4 months
description: Time it takes to get up from a chair walk around a cone and sit back down (8-foot up and go)
measure: Change from baseline 30-second chair stands (number of stands) at 4 months
time frame: 0 to 4 months
description: the number of chair stands completed in 30 seconds
measure: Change from baseline handgrip strength at 4 months
time frame: 0 to 4 months
description: the highest weight achieved from 2 attempts using the JAMAR dynamometer
measure: Change from baseline grooved pegboard time at 4 months
time frame: 0 to 4 months
description: measure of hand dexterity, time it takes to fit pegs into grooved pegboard
measure: Change from baseline fat mass (%) at 4 months
time frame: 0 to 4 months
description: Body fat mass (%) as measured by Bodpod
measure: Change from baseline fat mass (kgs) at 4 months
time frame: 0 to 4 months
description: Body fat mass (kg) as measured by Bodpod
measure: Change from baseline lean mass (kgs) at 4 months
time frame: 0 to 4 months
description: Body lean mass (kg) as measured by Bodpod
measure: Change from baseline lean mass (%) at 4 months
time frame: 0 to 4 months
description: Body lean mass (%) as measured by Bodpod
measure: Change from baseline minimal waist circumference at 4 months
time frame: 0 to 4 months
description: Body proportions will be measured at the minimal waist using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
measure: Change from baseline umbilical waist circumference at 4 months
time frame: 0 to 4 months
description: Body proportions will be measured at the umbilical waist using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
measure: Change from baseline hip circumference at 4 months
time frame: 0 to 4 months
description: Body proportions will be measured at the hip using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
measure: Change from baseline total calories at 4 months
time frame: 0 to 4 months
description: Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)
measure: Change from baseline macronutrient intake at 4 months
time frame: 0 to 4 months
description: Macronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)
measure: Change from baseline micronutrient intake at 4 months
time frame: 0 to 4 months
description: Micronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)
measure: Change from baseline Symbol digit modalities test at 4 months
time frame: 0 to 4 months
description: Symbol Digit Modalities Test measures cognitive impairment
measure: Change from baseline Trail Making Test at 4 months
time frame: 0 to 4 months
description: Trail Making Test neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
measure: Change from baseline Hopkins Verbal Learning Test at 4 months
time frame: 0 to 4 months
description: Hopkins Verbal Learning Test consists of three trials of free-recall of a 12-item, semantically categorized list, followed by yes/no recognition.
measure: Change from baseline Profile of Mood States at 4 months
time frame: 0 to 4 months
description: Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from "not at all" to "extremely".
measure: Change from baseline Perceived Stress Scale at 4 months
time frame: 0 to 4 months
description: Perceived Stress Scale is a a 12-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
measure: Change from Baseline Insulin Sensitivity at 4 months
time frame: 0 to 4 months
description: insulin sensitivity HOMA-β (= 360 x insulin mg/dL / glucose mg/dL - 63; %).
arm group label: WL-Control
arm group type: Placebo Comparator
description: Weight loss intervention (WL-Control; n = 20): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d.
arm group label: WL-Protein
arm group type: Active Comparator
description: High-protein weight loss intervention (WL-Protein; n = 20): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal sources (high quality) and 60-70% of animal protein from eggs or egg protein powder that will be provided to WL-Protein participants.
intervention type: Behavioral
intervention name: Weight Loss
description: Participants will be prescribed hypo-caloric diet by a registered dietitian and attend weekly social support/nutrition education meetings.
arm group label: WL-Control
arm group label: WL-Protein
intervention type: Dietary Supplement
intervention name: Egg Protein
description: Participants will be provided pre-packaged hard-boiled eggs (3/day, medium) and egg white protein powder.
arm group label: WL-Protein
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Connie Bales, RD, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
url: https://medschool.duke.edu/
description: Duke University School of Medicine
url: https://www.eggnutritioncenter.org/
description: Egg Nutrition Center
citation: Porter Starr KN, McDonald SR, Bales CW. Obesity and physical frailty in older adults: a scoping review of lifestyle intervention trials. J Am Med Dir Assoc. 2014 Apr;15(4):240-50. doi: 10.1016/j.jamda.2013.11.008. Epub 2014 Jan 17.
PMID: 24445063
citation: Porter Starr KN, Pieper CF, Orenduff MC, McDonald SR, McClure LB, Zhou R, Payne ME, Bales CW. Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1369-75. doi: 10.1093/gerona/glv210. Epub 2016 Jan 18.
PMID: 26786203
citation: Porter Starr KN, McDonald SR, Weidner JA, Bales CW. Challenges in the Management of Geriatric Obesity in High Risk Populations. Nutrients. 2016 May 4;8(5):262. doi: 10.3390/nu8050262.
PMID: 27153084
responsible party type: Sponsor
mesh term: Obesity
mesh term: Insulin Resistance
mesh term: Prediabetic State
sharing ipd: No