<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/NCT03267745</url>
  </required_header>
  <id_info>
    <org_study_id>3365</org_study_id>
    <nct_id>NCT03267745</nct_id>
  </id_info>
  <brief_title>Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization</brief_title>
  <official_title>Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Axcella Health, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a safety and tolerability study investigating the effect of an amino acid formulation&#xD;
      in healthy volunteers during and after limb immobilization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 19, 2017</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>
    <intervention_model_description>2 groups of 10 each will be randomized to receive amino acid supplementation or placebo for 28 days during which they will have one leg immobilized by a removable brace.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Sachets with the supplement will be blinded to the participant, and research assistants. Outcomes assessors will be blinded to condition as well.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in muscle atrophy</measure>
    <time_frame>day 0, day 8, day 15 and day 28</time_frame>
    <description>To determine the impact of an amino acid formulation on muscle atrophy after 7 days of amino acid supplementation followed by 7 days of single leg immobilization and 14 days of recovery post-immobilization muscle atrophy will be assessed utilizing percutaneous muscle biopsy to quantify fibre size in the vastus lateralis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in muscle strength</measure>
    <time_frame>day 0, day 8, day 15 and day 28</time_frame>
    <description>Strength will be measured using a Biodex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in muscle size</measure>
    <time_frame>day 0, day 8, day 15 and day 28</time_frame>
    <description>Muscle size will be assessed via MRI.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Muscle Atrophy</condition>
  <arm_group>
    <arm_group_label>Amino Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive amino acid supplementation (23.7g) 3 times daily for 28 days. Amino acids will be provided in powder form to be dissolved in 8oz of water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in this arm will receive placebo 3 times daily for 28 days. Placebo will consist of 23.7g of excipient-matched placebo in water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Amino Acid</intervention_name>
    <description>23.7 g amino acid 3 times daily for 28 days</description>
    <arm_group_label>Amino Acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Breg Brace single-leg immobilization</intervention_name>
    <description>7 days of single leg immobilization; randomized to leg; knee brace will be worn in a fixed flexion position at 140°.</description>
    <arm_group_label>Amino Acid</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Breg brace</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Excipient-matched placebo 3 times daily for 28 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Generally healthy, non-smoking&#xD;
&#xD;
          2. Willing and able to provide informed consent&#xD;
&#xD;
          3. Men age 20-45 years&#xD;
&#xD;
          4. BMI between 25 and 35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Smoker;&#xD;
&#xD;
          2. Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the&#xD;
             opinion of the Investigator, would compromise his/her ability to comply with the study&#xD;
             requirements;&#xD;
&#xD;
          3. History of cancer within the last 5 years, except basal cell carcinoma, non-squamous&#xD;
             skin carcinoma, prostate cancer or carcinoma in situ with no significant progression&#xD;
             over the past 2 years;&#xD;
&#xD;
          4. Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease,&#xD;
             immune disorder (requiring ongoing medical care), or metabolic/endocrine disorder&#xD;
             (e.g., diabetes, high cholesterol, elevated fasting blood sugar) or other disease that&#xD;
             would preclude oral protein supplement ingestion and/or assessment of safety and study&#xD;
             objectives;&#xD;
&#xD;
          5. Any cachexia-related condition (e.g., relating to cancer, tuberculosis or human&#xD;
             immunodeficiency virus infection and acquired immune deficiency syndrome) or any&#xD;
             genetic muscle diseases or disorders;&#xD;
&#xD;
          6. Current illnesses which could interfere with the study (e.g. prolonged severe&#xD;
             diarrhea, regurgitation, difficulty swallowing);&#xD;
&#xD;
          7. Subject participated in a study of an investigational product less than 60 days or 5&#xD;
             half-lives of the investigational product, whichever is longer, before enrollment in&#xD;
             this study;&#xD;
&#xD;
          8. Hypersensitivity to any of the components of the test product;&#xD;
&#xD;
          9. Excessive alcohol consumption (&gt;21 units/week); (&gt; 21 standard drinks/wk); e.g., 18oz&#xD;
             glass of 5% beer - 1.5 standard drinks, a 750 mL bottle of 12% wine = 5 standard&#xD;
             drinks.&#xD;
&#xD;
         10. Known sensitivity or allergy to amino acids or any ingredient in the test&#xD;
             formulations;&#xD;
&#xD;
         11. Prior gastrointestinal bypass surgery (Lapband, etc.), irritable bowel disease or&#xD;
             irritable bowel syndrome;&#xD;
&#xD;
         12. History of bleeding diathesis, platelet or coagulation disorders, or&#xD;
             antiplatelet/anticoagulation therapy (up to 81mg of baby aspirin per day taken as a&#xD;
             prophylactic is permitted);&#xD;
&#xD;
         13. Personal or family history of clotting disorder or deep vein thrombosis. Deep vein&#xD;
             thrombosis is a serious, and potentially lethal, medical condition, therefore, it is&#xD;
             imperative if you have personal or family history it is disclosed this to the research&#xD;
             staff.&#xD;
&#xD;
         14. Concomitant use of corticosteroids, testosterone replacement therapy (ingestion,&#xD;
             injection, or transdermal), any anabolic steroid, creatine, whey protein supplements,&#xD;
             casein or branched-chain amino acids (BCAAs) within 45 days prior to Screening;&#xD;
&#xD;
         15. Contraindications to an MRI scan (e.g. subjects with non-removable ferromagnetic&#xD;
             implants, pacemakers, aneurysm clips or other foreign bodies, or subjects with&#xD;
             claustrophobic symptoms that would contraindicate an MRI scan).&#xD;
&#xD;
         16. Hemoglobin &lt;11.5mg/dl at Screening;&#xD;
&#xD;
         17. Platelets &lt;150,000/uL (150x109/L) at Screening.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stuart M Phillips, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster Univeristy</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>June 17, 2019</last_update_submitted>
  <last_update_submitted_qc>June 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>protein</keyword>
  <keyword>skeletal muscle</keyword>
  <keyword>immobilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</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/NCT03267745
org study id: 3365
nct id: NCT03267745
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a safety and tolerability study investigating the effect of an amino acid formulation
      in healthy volunteers during and after limb immobilization.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 groups of 10 each will be randomized to receive amino acid supplementation or placebo for 28 days during which they will have one leg immobilized by a removable brace.
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Sachets with the supplement will be blinded to the participant, and research assistants. Outcomes assessors will be blinded to condition as well.
measure: Change in muscle atrophy
time frame: day 0, day 8, day 15 and day 28
description: To determine the impact of an amino acid formulation on muscle atrophy after 7 days of amino acid supplementation followed by 7 days of single leg immobilization and 14 days of recovery post-immobilization muscle atrophy will be assessed utilizing percutaneous muscle biopsy to quantify fibre size in the vastus lateralis.
measure: Change in muscle strength
time frame: day 0, day 8, day 15 and day 28
description: Strength will be measured using a Biodex.
measure: Change in muscle size
time frame: day 0, day 8, day 15 and day 28
description: Muscle size will be assessed via MRI.
arm group label: Amino Acid
arm group type: Experimental
description: Subjects in this arm will receive amino acid supplementation (23.7g) 3 times daily for 28 days. Amino acids will be provided in powder form to be dissolved in 8oz of water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects in this arm will receive placebo 3 times daily for 28 days. Placebo will consist of 23.7g of excipient-matched placebo in water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period.
intervention type: Dietary Supplement
intervention name: Amino Acid
description: 23.7 g amino acid 3 times daily for 28 days
arm group label: Amino Acid
intervention type: Device
intervention name: Breg Brace single-leg immobilization
description: 7 days of single leg immobilization; randomized to leg; knee brace will be worn in a fixed flexion position at 140°.
arm group label: Amino Acid
arm group label: Placebo
other name: Breg brace
intervention type: Other
intervention name: Placebo
description: Excipient-matched placebo 3 times daily for 28 days
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stuart M Phillips, PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Muscular Atrophy
sharing ipd: No