<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/NCT01735539</url>
  </required_header>
  <id_info>
    <org_study_id>UNottingham F/3/2009</org_study_id>
    <nct_id>NCT01735539</nct_id>
  </id_info>
  <brief_title>Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance With Age; the Role of Amino Acids in Modulating Muscle Metabolism</brief_title>
  <acronym>Ajinomoto1A</acronym>
  <official_title>Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance in Older People; The Role of Essential Amino Acids in Modulating Muscle Protein Metabolism; Bolus vs. Pulse Feeding Strategies and the Ability of Arginine to Rejuvenate Microvascular Responsiveness.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators plan to measure changes in muscle protein metabolism in response to&#xD;
      feeding, comparing between a single large essential amino acid (EAA) feed (the normal&#xD;
      building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min&#xD;
      intervals. The investigators will perform this study in healthy older (65-75y) and younger&#xD;
      (18-28) men. The investigators will also explore how feeding affects muscle blood flow as&#xD;
      this is important in the delivery of the nutrients we eat to the muscle where they are used.&#xD;
&#xD;
      The investigators plan to supplement the feed with arginine, a safe and widely found&#xD;
      non-essential amino acid, to explore if this can improve muscle blood flow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will provide a 15g mixed essential amino acid feed or 4 x 3.75g.&#xD;
&#xD;
      There is sexual dimorphism thus initially we will just recruit males. Powering calculations&#xD;
      dictate n=8 in each group.&#xD;
&#xD;
      We will use well established stable isotope tracer techniques (with 13C6 Phenylalanine) to&#xD;
      measure muscle protein synthesis and breakdown by Gas Chromatography - combustion - isotope&#xD;
      ratio mass spectroscopy.&#xD;
&#xD;
      We will measure leg blood flow by phase shift Doppler and muscle microvascular flow by&#xD;
      contrast enhanced ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2011</start_date>
  <completion_date type="Anticipated">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Protein Synthesis (FSR, fractional synthetic rate, %/hr)</measure>
    <time_frame>Across 6hr study</time_frame>
    <description>We measure FSR when fasted and again 0-90, 90-180 and 180-240 post feed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle Protein Breakdown (MPB)</measure>
    <time_frame>Across 6hr study</time_frame>
    <description>MBP is measured during fasting and 0-90, 90-180 and 180-240mins post feed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole leg blood flow</measure>
    <time_frame>Across a 6hr study</time_frame>
    <description>We measure common femoral blood flow by doppler ultrasound when fasted and again 0-90, 90-180 and 180-240 post feed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Microvascular Blood flow</measure>
    <time_frame>Across a 6hr study</time_frame>
    <description>We measure muscle microvascular flow using contrast enhanced ultrasound when fasted and again 0-90, 90-180 and 180-240 post feed.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Old Age (Focus; Not a Recognized Condition)</condition>
  <arm_group>
    <arm_group_label>Old Bolus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15g EAA bolus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Old Arginine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15g EAA Bolus supplemented with 3g Arginine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Young Bolus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15g EAA bolus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Young Pulse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 x 3.75g Mixed EAA Pulses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Old Pulse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 x 3.75g Mixed EAA Pulses</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>15g EAA bolus</intervention_name>
    <description>Oral; in aqueous solution</description>
    <arm_group_label>Old Bolus</arm_group_label>
    <arm_group_label>Young Bolus</arm_group_label>
    <other_name>Mixed Essential Amino Acids</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>4 x 3.75g Mixed EAA Pulses</intervention_name>
    <description>Oral; in aqueous solution</description>
    <arm_group_label>Old Pulse</arm_group_label>
    <arm_group_label>Young Pulse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>15g EAA Bolus supplemented with 3g Arginine</intervention_name>
    <description>Oral; in aqueous solution</description>
    <arm_group_label>Old Arginine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 65-75 or 18-28&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;30&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Beta blocker or steroid use&#xD;
&#xD;
          -  Established cerebrovascular, peripheral vascular or ischaemic heart disease.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip J Atherton, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nottingham School of Graduate Entry Medicine and Health</name>
      <address>
        <city>Derby</city>
        <zip>DE23 6PF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>January 16, 2014</last_update_submitted>
  <last_update_submitted_qc>January 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>old age</keyword>
  <keyword>sarcopenia</keyword>
  <keyword>essential amino acid</keyword>
  <keyword>arginine</keyword>
  <keyword>contrast enhanced ultrasound</keyword>
  <keyword>muscle microcirculation</keyword>
  <keyword>muscle protein synthesis</keyword>
  <!-- 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/NCT01735539
org study id: UNottingham F/3/2009
nct id: NCT01735539
lead sponsor: 
has dmc: Yes
The investigators plan to measure changes in muscle protein metabolism in response to
      feeding, comparing between a single large essential amino acid (EAA) feed (the normal
      building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min
      intervals. The investigators will perform this study in healthy older (65-75y) and younger
      (18-28) men. The investigators will also explore how feeding affects muscle blood flow as
      this is important in the delivery of the nutrients we eat to the muscle where they are used.

      The investigators plan to supplement the feed with arginine, a safe and widely found
      non-essential amino acid, to explore if this can improve muscle blood flow.
We will provide a 15g mixed essential amino acid feed or 4 x 3.75g.

      There is sexual dimorphism thus initially we will just recruit males. Powering calculations
      dictate n=8 in each group.

      We will use well established stable isotope tracer techniques (with 13C6 Phenylalanine) to
      measure muscle protein synthesis and breakdown by Gas Chromatography - combustion - isotope
      ratio mass spectroscopy.

      We will measure leg blood flow by phase shift Doppler and muscle microvascular flow by
      contrast enhanced ultrasound.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Muscle Protein Synthesis (FSR, fractional synthetic rate, %/hr)
time frame: Across 6hr study
description: We measure FSR when fasted and again 0-90, 90-180 and 180-240 post feed.
measure: Muscle Protein Breakdown (MPB)
time frame: Across 6hr study
description: MBP is measured during fasting and 0-90, 90-180 and 180-240mins post feed.
measure: Whole leg blood flow
time frame: Across a 6hr study
description: We measure common femoral blood flow by doppler ultrasound when fasted and again 0-90, 90-180 and 180-240 post feed.
measure: Muscle Microvascular Blood flow
time frame: Across a 6hr study
description: We measure muscle microvascular flow using contrast enhanced ultrasound when fasted and again 0-90, 90-180 and 180-240 post feed.
arm group label: Old Bolus
arm group type: Experimental
description: 15g EAA bolus
arm group label: Old Arginine
arm group type: Experimental
description: 15g EAA Bolus supplemented with 3g Arginine
arm group label: Young Bolus
arm group type: Experimental
description: 15g EAA bolus
arm group label: Young Pulse
arm group type: Experimental
description: 4 x 3.75g Mixed EAA Pulses
arm group label: Old Pulse
arm group type: Experimental
description: 4 x 3.75g Mixed EAA Pulses
intervention type: Dietary Supplement
intervention name: 15g EAA bolus
description: Oral; in aqueous solution
arm group label: Old Bolus
arm group label: Young Bolus
other name: Mixed Essential Amino Acids
intervention type: Dietary Supplement
intervention name: 4 x 3.75g Mixed EAA Pulses
description: Oral; in aqueous solution
arm group label: Old Pulse
arm group label: Young Pulse
intervention type: Dietary Supplement
intervention name: 15g EAA Bolus supplemented with 3g Arginine
description: Oral; in aqueous solution
arm group label: Old Arginine
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philip J Atherton, PhD
role: Principal Investigator
affiliation: University of Nottingham
facility: 
country: United Kingdom
responsible party type: Sponsor