<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/NCT01715753</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00037110</org_study_id>
    <secondary_id>3834193</secondary_id>
    <nct_id>NCT01715753</nct_id>
  </id_info>
  <brief_title>Measuring Eating, Activity and Strength: Understanding the Response -Using Protein</brief_title>
  <acronym>MEASUR-UP</acronym>
  <official_title>Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the trial is to assess the effects of weight loss on functional status and&#xD;
      lean muscle mass in frail, obese older adults (&gt;/= 60) who participate in a 6 month weight&#xD;
      reduction intervention. Participants will be randomized into one of two study arms: Weight&#xD;
      Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or&#xD;
      Weight Loss-High Protein: (n = 50) subjects follow a calorie-reduction diet for a weight loss&#xD;
      of ≥10%, with a high proportion of high quality protein at each meal. Intakes of &gt; 30g of&#xD;
      high quality protein will be achieved three times a day by subjects in this group,&#xD;
      predominantly all from animal sources and 60-70% of animal protein from beef. Subject&#xD;
      criteria will include obese (&gt;30 kg/m2) older adults (&gt;60 yrs.) with mild to moderate&#xD;
      functional impairment (by Short Physical Performance Battery; SPPB score &gt;/= 4)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Short Physical Performance Battery (SPPB)</measure>
    <time_frame>Baseline to 3 to 6 months</time_frame>
    <description>short physical performance battery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lean body mass</measure>
    <time_frame>Baseline to 3 and 6 months</time_frame>
    <description>Bodpod</description>
  </primary_outcome>
  <other_outcome>
    <measure>Change in baseline lipids (classes, subclasses, participle size and number) at 6 months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Concentrations for lipoprotein classes (VLDL, LDL and HDL particle numbers) and subclasses (small, medium and large) were calculated using the LP3 deconvolution algorithm. Mean VLDL, LDL and HDL particle sizes were weighted averages derived from the sum of the diameter of each subclass multiplied by its relative mass percentage.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in baseline GlycA at 6 months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>NMR-measured systemic inflammatory factor and a biomarker of CVD risk</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in baseline trimethylamine-N-oxide (TMAO) at 6 months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>TMAO is a metabolite produced from trimethylamine (TMA) containing nutrients. Nuclear magnetic resonance (NMR) spectroscopy assay was used for quantification of TMAO concentrations.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in baseline betaine at 6 months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Betaine was measured by 1H-nuclear magnetic resonance (NMR) spectroscopy using a Vantera® NMR Clinical Analyzer (LabCorp, Raleigh, NC).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in baseline branched chain amino acids (BCAA) at 6 months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>NMR MetaboProfile analysis, which reports concentrations of several metabolites [ the branched chain amino acids (BCAA) valine, leucine, and isoleucine] was performed using the recently developed LP3 deconvolution algorithm.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 6 months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>LP-IR is a composite metabolomic biomarker that captures the multidimensional effects of insulin resistance on the lipoprotein metabolic chain. It is measured by nuclear magnetic resonance spectroscopy as a weighted score of VLDL, LDL and HDL particle sizes, and their subsets concentrations.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in baseline GFR at 6 months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Estimated GFR, which measures renal filtering capacity, is a calculated value based on age, sex, race, and serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in baseline fasting glucose at 6 months</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Level of glucose in the blood after fasting for at least 8 hours</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Weight Loss Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight Loss-High Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protein supplementation. Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of protein, including substantial amounts of supplemental protein provided as lean beef. Intakes of &gt; 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Protein supplementation</intervention_name>
    <description>&gt; 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef.</description>
    <arm_group_label>Weight Loss-High Protein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diet counseling and group education lessons</intervention_name>
    <description>Individual and group diet counseling to achieve a &gt;10% weight loss</description>
    <arm_group_label>Weight Loss Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 60+ yrs.&#xD;
&#xD;
          -  BMI of &gt;30 kg/m2&#xD;
&#xD;
          -  Body weight &lt;495 lbs.&#xD;
&#xD;
          -  Normal blood chemistries&#xD;
&#xD;
          -  Normal renal function&#xD;
&#xD;
          -  Primary care physician acknowledgement&#xD;
&#xD;
          -  Non-Vegetarian&#xD;
&#xD;
          -  Mild to moderate movement impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body weight &gt;495 pounds.&#xD;
&#xD;
          -  Current smoker.&#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;
          -  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 six months.&#xD;
&#xD;
          -  Inability to walk independently.&#xD;
&#xD;
          -  Bilateral hip replacements.&#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.&#xD;
&#xD;
          -  Primary Care Physician advises against participation.&#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 W Bales, PhD, RD</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>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Function</keyword>
  <keyword>Muscle mass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</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/NCT01715753
org study id: Pro00037110
secondary id: 3834193
nct id: NCT01715753
lead sponsor: 
has dmc: Yes
The purpose of the trial is to assess the effects of weight loss on functional status and
      lean muscle mass in frail, obese older adults (>/= 60) who participate in a 6 month weight
      reduction intervention. Participants will be randomized into one of two study arms: Weight
      Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or
      Weight Loss-High Protein: (n = 50) 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
      high quality protein will be achieved three times a day by subjects in this group,
      predominantly all from animal sources and 60-70% of animal protein from beef. Subject
      criteria will include obese (>30 kg/m2) older adults (>60 yrs.) with mild to moderate
      functional impairment (by Short Physical Performance Battery; SPPB score >/= 4)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Change in Short Physical Performance Battery (SPPB)
time frame: Baseline to 3 to 6 months
description: short physical performance battery
measure: Change in lean body mass
time frame: Baseline to 3 and 6 months
description: Bodpod
measure: Change in baseline lipids (classes, subclasses, participle size and number) at 6 months
time frame: Baseline to 6 months
description: Concentrations for lipoprotein classes (VLDL, LDL and HDL particle numbers) and subclasses (small, medium and large) were calculated using the LP3 deconvolution algorithm. Mean VLDL, LDL and HDL particle sizes were weighted averages derived from the sum of the diameter of each subclass multiplied by its relative mass percentage.
measure: Changes in baseline GlycA at 6 months
time frame: Baseline to 6 months
description: NMR-measured systemic inflammatory factor and a biomarker of CVD risk
measure: Change in baseline trimethylamine-N-oxide (TMAO) at 6 months
time frame: Baseline to 6 months
description: TMAO is a metabolite produced from trimethylamine (TMA) containing nutrients. Nuclear magnetic resonance (NMR) spectroscopy assay was used for quantification of TMAO concentrations.
measure: Change in baseline betaine at 6 months
time frame: Baseline to 6 months
description: Betaine was measured by 1H-nuclear magnetic resonance (NMR) spectroscopy using a Vantera® NMR Clinical Analyzer (LabCorp, Raleigh, NC).
measure: Change in baseline branched chain amino acids (BCAA) at 6 months
time frame: Baseline to 6 months
description: NMR MetaboProfile analysis, which reports concentrations of several metabolites [ the branched chain amino acids (BCAA) valine, leucine, and isoleucine] was performed using the recently developed LP3 deconvolution algorithm.
measure: Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 6 months
time frame: Baseline to 6 months
description: LP-IR is a composite metabolomic biomarker that captures the multidimensional effects of insulin resistance on the lipoprotein metabolic chain. It is measured by nuclear magnetic resonance spectroscopy as a weighted score of VLDL, LDL and HDL particle sizes, and their subsets concentrations.
measure: Change in baseline GFR at 6 months
time frame: Baseline to 6 months
description: Estimated GFR, which measures renal filtering capacity, is a calculated value based on age, sex, race, and serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
measure: Change in baseline fasting glucose at 6 months
time frame: Baseline to 6 months
description: Level of glucose in the blood after fasting for at least 8 hours
arm group label: Weight Loss Control
arm group type: Active Comparator
description: Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.
arm group label: Weight Loss-High Protein
arm group type: Experimental
description: Protein supplementation. Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of protein, including substantial amounts of supplemental protein provided as lean beef. Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef.
intervention type: Dietary Supplement
intervention name: Protein supplementation
description: > 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef.
arm group label: Weight Loss-High Protein
intervention type: Behavioral
intervention name: Diet counseling and group education lessons
description: Individual and group diet counseling to achieve a >10% weight loss
arm group label: Weight Loss Control
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Connie W Bales, PhD, RD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Weight Loss