<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/NCT01662414</url>
  </required_header>
  <id_info>
    <org_study_id>53653</org_study_id>
    <nct_id>NCT01662414</nct_id>
  </id_info>
  <brief_title>Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease</brief_title>
  <official_title>Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease: Changes in Biomarkers of Oxidative Stress, Profiles of Plasma Amino Acids and Their Derivatives and Brain Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <brief_summary>
    <textblock>
      This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus placebo&#xD;
      (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's Disease.&#xD;
&#xD;
      The principal objective is to evaluate the changes in biomarkers of oxidative stress&#xD;
      and,plasma amino acids, as well as improvement of clinical symptoms and brain function&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Clinical Global impression (CGI) - Change scale score, change from baseline to week 24</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Clinical Global impression (CGI) - Severity scale score change from baseline to week 24</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Parkinson's Disease quality of life questionnaire score change from baseline to week 24</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutrition Questionnaire score change baseline to week 24</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Parkinsonian Disorders</condition>
  <condition>Basal Ganglia Diseases</condition>
  <condition>Brain Diseases</condition>
  <condition>Central Nervous System Diseases</condition>
  <condition>Nervous System Diseases</condition>
  <condition>Movement Disorders</condition>
  <condition>Neurodegenerative Diseases</condition>
  <arm_group>
    <arm_group_label>HMS 90®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Soy protein)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey protein</intervention_name>
    <description>1 sachect (10 g) 2times/ day</description>
    <arm_group_label>HMS 90®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Soy protein</intervention_name>
    <description>1 sachect (10g) 2times/day</description>
    <arm_group_label>Placebo (Soy protein)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects with Idiopathic Parkinson's Disease&#xD;
&#xD;
          2. Subjects who are willing and able to participate in the trial and has provided&#xD;
             written, informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who are allergic to Whey protein (HMS 90®).&#xD;
&#xD;
          2. Subjects who are treated with chemotherapy .&#xD;
&#xD;
          3. Subjects with any history of neurodegenerative diseases, e.g., Alzheimer's disease.&#xD;
&#xD;
          4. Subjects with history of diabetes. 4.5. Subjects with abnormal liver function test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roongroj Bhidayasiri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chulalongkorn University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chulalongkorn University Hospital</name>
      <address>
        <city>Pathumwan</city>
        <state>Bangkok</state>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>September 27, 2013</last_update_submitted>
  <last_update_submitted_qc>September 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Movement Disorders</mesh_term>
    <mesh_term>Neurodegenerative Diseases</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
    <mesh_term>Parkinsonian Disorders</mesh_term>
    <mesh_term>Basal Ganglia Diseases</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/NCT01662414
org study id: 53653
nct id: NCT01662414
lead sponsor: 
This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus placebo
      (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's Disease.

      The principal objective is to evaluate the changes in biomarkers of oxidative stress
      and,plasma amino acids, as well as improvement of clinical symptoms and brain function
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status
time frame: 6 months
measure: Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan
time frame: 6 months
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24
time frame: 6 months
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24
time frame: 6 months
measure: • Clinical Global impression (CGI) - Change scale score, change from baseline to week 24
time frame: 6 months
measure: • Clinical Global impression (CGI) - Severity scale score change from baseline to week 24
time frame: 6 months
measure: • Parkinson's Disease quality of life questionnaire score change from baseline to week 24
time frame: 6 months
measure: Nutrition Questionnaire score change baseline to week 24
time frame: 6 months
arm group label: HMS 90®
arm group type: Active Comparator
arm group label: Placebo (Soy protein)
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Whey protein
description: 1 sachect (10 g) 2times/ day
arm group label: HMS 90®
intervention type: Dietary Supplement
intervention name: Soy protein
description: 1 sachect (10g) 2times/day
arm group label: Placebo (Soy protein)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Roongroj Bhidayasiri, MD
role: Principal Investigator
affiliation: Chulalongkorn University
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Nervous System Diseases
mesh term: Movement Disorders
mesh term: Neurodegenerative Diseases
mesh term: Brain Diseases
mesh term: Central Nervous System Diseases
mesh term: Parkinsonian Disorders
mesh term: Basal Ganglia Diseases