<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/NCT02971059</url>
  </required_header>
  <id_info>
    <org_study_id>1000051682</org_study_id>
    <nct_id>NCT02971059</nct_id>
  </id_info>
  <brief_title>Phenylalanine Requirement of Adults &gt;65 Years.</brief_title>
  <official_title>Phenylalanine Requirement of Healthy Older Adult Males and Females &gt; 65 Years Determined by Direct Amino Acid Oxidation (DAAO) Method.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently there are insufficient published studies on amino acid requirements in the elderly.&#xD;
      Phenylalanine is one of the indispensable amino acids. Low levels of phenylalanine has been&#xD;
      observed in in the blood of older adults. It is due the increased uptake by the liver and&#xD;
      intestine. This decreased levels of phenylalanine could lead to decreased skeletal muscle&#xD;
      protein synthesis. Requirement for elderly individuals have been set based on studies&#xD;
      conducted in younger adults hence may be inaccurate. The goal of this study is to directly&#xD;
      measure the phenylalanine requirement of male and female elderly subjects over 65 years using&#xD;
      the direct amino acid oxidation (DAAO) technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To determine and compare the phenylalanine requirement of healthy elderly male and&#xD;
           female adults over the age of 65 years using the DAAO technique (by measuring the&#xD;
           oxidation of L-[1-13 C] phenylalanine to 13 CO 2 [F 13 CO 2] ) in response to graded&#xD;
           intakes of phenylalanine.&#xD;
&#xD;
        2. To compare the requirement so derived to that of young healthy adult previously&#xD;
           determined in our lab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phenylalanine Requirement</measure>
    <time_frame>Baseline</time_frame>
    <description>To determine phenylalanine requirement by measuring the oxidation of 13CO2 in breath in response to graded phenylalanine intakes</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Older Adults</condition>
  <arm_group>
    <arm_group_label>Adult Males &gt;65 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult Females &gt;65 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Phenylalanine intake</intervention_name>
    <description>Phenylalanine will be provided as graded intakes ranging from 7-40 mg/kg/day</description>
    <arm_group_label>Adult Females &gt;65 years</arm_group_label>
    <arm_group_label>Adult Males &gt;65 years</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy elderly males and females &gt; 65 years&#xD;
&#xD;
          2. Willingness to participate in the study and completed the screening procedures&#xD;
             (height, weight, fasting blood sample and medical history questionnaire).&#xD;
&#xD;
          3. No recent history of weight loss&#xD;
&#xD;
          4. Absence of chronic disease or acute illness that could affect protein and AA&#xD;
             metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or&#xD;
             hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.&#xD;
&#xD;
          5. Non-smoking&#xD;
&#xD;
          6. Willingness to consume the diet provided&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of disease known to affect protein and AA metabolism (diabetes, cancer, liver&#xD;
             or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid&#xD;
             arthritis treated with anti-inflammatory medications).&#xD;
&#xD;
          2. On medications known to affect protein and amino acid metabolism (steroids).&#xD;
&#xD;
          3. Recent significant weight loss.&#xD;
&#xD;
          4. Individual on weight reducing diets.&#xD;
&#xD;
          5. Inability to tolerate the diet&#xD;
&#xD;
          6. Unwilling to have blood drawn from a venous access, or using a ventilated hood&#xD;
             indirect calorimeter for the purposes of the study.&#xD;
&#xD;
          7. Significant coffee consumption of more than 2 cups/day&#xD;
&#xD;
          8. Significant alcohol consumption of more than one drink/day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glenda Courtney-Martin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Sick Children, Toronto, Ontario</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1x8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>September 14, 2018</last_update_submitted>
  <last_update_submitted_qc>September 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Glenda Courtney-Martin</investigator_full_name>
    <investigator_title>Project Investigator</investigator_title>
  </responsible_party>
  <keyword>Elderly</keyword>
  <keyword>Phenylalanine</keyword>
  <keyword>Healthy</keyword>
  <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/NCT02971059
org study id: 1000051682
nct id: NCT02971059
lead sponsor: 
has dmc: No
Currently there are insufficient published studies on amino acid requirements in the elderly.
      Phenylalanine is one of the indispensable amino acids. Low levels of phenylalanine has been
      observed in in the blood of older adults. It is due the increased uptake by the liver and
      intestine. This decreased levels of phenylalanine could lead to decreased skeletal muscle
      protein synthesis. Requirement for elderly individuals have been set based on studies
      conducted in younger adults hence may be inaccurate. The goal of this study is to directly
      measure the phenylalanine requirement of male and female elderly subjects over 65 years using
      the direct amino acid oxidation (DAAO) technique.
1. To determine and compare the phenylalanine requirement of healthy elderly male and
           female adults over the age of 65 years using the DAAO technique (by measuring the
           oxidation of L-[1-13 C] phenylalanine to 13 CO 2 [F 13 CO 2] ) in response to graded
           intakes of phenylalanine.

        2. To compare the requirement so derived to that of young healthy adult previously
           determined in our lab.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Phenylalanine Requirement
time frame: Baseline
description: To determine phenylalanine requirement by measuring the oxidation of 13CO2 in breath in response to graded phenylalanine intakes
arm group label: Adult Males >65 years
arm group type: Experimental
description: Participants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours.
arm group label: Adult Females >65 years
arm group type: Experimental
description: Participants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours.
intervention type: Dietary Supplement
intervention name: Phenylalanine intake
description: Phenylalanine will be provided as graded intakes ranging from 7-40 mg/kg/day
arm group label: Adult Females >65 years
arm group label: Adult Males >65 years
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Glenda Courtney-Martin
role: Principal Investigator
affiliation: Hospital for Sick Children, Toronto, Ontario
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Glenda Courtney-Martin
investigator title: Project Investigator
sharing ipd: No