<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/NCT03765710</url>
  </required_header>
  <id_info>
    <org_study_id>204291</org_study_id>
    <nct_id>NCT03765710</nct_id>
  </id_info>
  <brief_title>Role of Dietary Protein Intake in Elderly Adults</brief_title>
  <official_title>Role of Dietary Protein Intake on Whole Body Protein Balance in Elderly Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators examined the effects of dietary protein intake in a mixed meal at two&#xD;
      levels of protein amount on whole body protein metabolisms in older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators determined the total anabolic response to an amount of protein intake&#xD;
      commonly eaten with dinner (70g) as compared with the amount required to maximally stimulate&#xD;
      muscle protein synthesis (35g). Men and women, ages &gt; 60 years will be studied under two&#xD;
      levels of protein intake in mixed meals in random order (35g or 70g protein in isocaloric&#xD;
      mixed meals). For two days prior to each stable isotope tracer study, subjects' dietary&#xD;
      intake of calories and protein will be stabilized by providing subjects their entire diets.&#xD;
      On the third day, a 8-hr metabolic study will be conducted in the UAMS Reynolds Institute on&#xD;
      Aging (IOA) to determine the total anabolic response to the particular amount of beef intake,&#xD;
      which will be repeated with the other amount of protein in mixed meal after a minimum 7-day&#xD;
      washout interval. The investigators measured whole body protein kinetics, muscle fractional&#xD;
      synthetic rate, and plasma amino acid profile.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in whole body anabolism</measure>
    <time_frame>Change before and after a mixed meal intake for approximately 8 hours</time_frame>
    <description>Whole body net protein balance in gram protein</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in skeletal muscle synthetic rate</measure>
    <time_frame>Change before and after a mixed meal intake for approximately 8 hours</time_frame>
    <description>Skeletal muscle fractional synthetic rate in % synthesis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Protein Overload</condition>
  <arm_group>
    <arm_group_label>Recommended protein intake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects consumed a mixed meal with a macronutrient distribution of 13% protein, 54% carbohydrate, and 33% fat.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elevated protein intake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects consumed a mixed meal with a macronutrient distribution of 26% protein, 44% carbohydrate, and 30% fat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Recommended protein intake</intervention_name>
    <description>Recommended protein intake in a mixed meal contained 13% protein, 54% carbohydrate, and 33% fat.</description>
    <arm_group_label>Recommended protein intake</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Elevated protein intake</intervention_name>
    <description>Increased protein intake in a mixed meal contained 26% protein, 44% carbohydrate, and 30% fat.</description>
    <arm_group_label>Elevated protein intake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women, ages &gt; 60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of diabetes&#xD;
&#xD;
          -  History of malignancy in the 6 months prior to enrollment&#xD;
&#xD;
          -  History of gastrointestinal bypass surgery (Lapband, etc)&#xD;
&#xD;
          -  History of a chronic inflammatory condition or disease (Lupus, HIV/AIDS, etc)&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Subjects who do not or will not eat animal proteins&#xD;
&#xD;
          -  Subjects who cannot refrain from consuming protein or amino acid supplements during&#xD;
             their participation in this study&#xD;
&#xD;
          -  Subjects who report regular resistance exercise (more than once per week)&#xD;
&#xD;
          -  Hemoglobin less than 9.5 mg/dL at the screening visit&#xD;
&#xD;
          -  Platelets less than 150,000 at the screening visit&#xD;
&#xD;
          -  Subjects who are not willing or able to suspend aspirin for several days prior to&#xD;
             their muscle biopsies&#xD;
&#xD;
          -  Subjects who have been prescribed a blood-thinning medication (Coumadin, lovenox,&#xD;
             heparin, Plavix, etc.)&#xD;
&#xD;
          -  Concomitant use of corticosteroids (ingestion, injection or transdermal)&#xD;
&#xD;
          -  Any other disease or condition that would place the subject at increased risk of harm&#xD;
             if they were to participate, at the discretion of the study physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03765710
org study id: 204291
nct id: NCT03765710
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators examined the effects of dietary protein intake in a mixed meal at two
      levels of protein amount on whole body protein metabolisms in older adults.
The investigators determined the total anabolic response to an amount of protein intake
      commonly eaten with dinner (70g) as compared with the amount required to maximally stimulate
      muscle protein synthesis (35g). Men and women, ages > 60 years will be studied under two
      levels of protein intake in mixed meals in random order (35g or 70g protein in isocaloric
      mixed meals). For two days prior to each stable isotope tracer study, subjects' dietary
      intake of calories and protein will be stabilized by providing subjects their entire diets.
      On the third day, a 8-hr metabolic study will be conducted in the UAMS Reynolds Institute on
      Aging (IOA) to determine the total anabolic response to the particular amount of beef intake,
      which will be repeated with the other amount of protein in mixed meal after a minimum 7-day
      washout interval. The investigators measured whole body protein kinetics, muscle fractional
      synthetic rate, and plasma amino acid profile.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes in whole body anabolism
time frame: Change before and after a mixed meal intake for approximately 8 hours
description: Whole body net protein balance in gram protein
measure: Changes in skeletal muscle synthetic rate
time frame: Change before and after a mixed meal intake for approximately 8 hours
description: Skeletal muscle fractional synthetic rate in % synthesis
arm group label: Recommended protein intake
arm group type: Experimental
description: Subjects consumed a mixed meal with a macronutrient distribution of 13% protein, 54% carbohydrate, and 33% fat.
arm group label: Elevated protein intake
arm group type: Experimental
description: Subjects consumed a mixed meal with a macronutrient distribution of 26% protein, 44% carbohydrate, and 30% fat.
intervention type: Other
intervention name: Recommended protein intake
description: Recommended protein intake in a mixed meal contained 13% protein, 54% carbohydrate, and 33% fat.
arm group label: Recommended protein intake
intervention type: Other
intervention name: Elevated protein intake
description: Increased protein intake in a mixed meal contained 26% protein, 44% carbohydrate, and 30% fat.
arm group label: Elevated protein intake
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor