<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/NCT01682694</url>
  </required_header>
  <id_info>
    <org_study_id>7798</org_study_id>
    <nct_id>NCT01682694</nct_id>
  </id_info>
  <brief_title>Glucosamine and Chondroitin Effects</brief_title>
  <acronym>GLANCE</acronym>
  <official_title>Glucosamine and Chondroitin Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected&#xD;
      by a reduction in serum C-reactive protein.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Use of glucosamine and chondroitin have been associated with reduced cancer and overall&#xD;
      mortality. The aim of this study is to determine whether a common starting dose of&#xD;
      glucosamine and chondroitin (1500 mg/d + 1200 mg/d, respectively) reduces systemic&#xD;
      inflammation as reflected by a reduction in high sensitivity C-reactive protein.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hsCRP</measure>
    <time_frame>1 year</time_frame>
    <description>hsCRP is a biomarker of systemic inflammation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>untargeted (exploratory) serum metabolomics (differences in small molecule abundance ratios)</measure>
    <time_frame>1 year</time_frame>
    <description>The mechanisms of action of glucosamine and chondroitin are currently unknown. Untargeted metabolomic assays of serum will be undertaken for exploratory analyses of potential effects of glucosamine and chondroitin. Significant differences in abundance ratios of small molecules between the intervention and placebo will be reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Glucosamine and Chondroitin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glucosamine and Chondroitin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Inactive ingredients</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glucosamine and Chondroitin</intervention_name>
    <description>Glucosamine (1500 mg) and Chondroitin (1200 mg)</description>
    <arm_group_label>Glucosamine and Chondroitin</arm_group_label>
    <other_name>Nutramax</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Overweight (body mass index kg/m2 (BMI) between 25 and 32.5)&#xD;
&#xD;
          -  Non-smoking men and women&#xD;
&#xD;
          -  Aged 20-55y&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or&#xD;
             inflammatory conditions (including autoimmune and inflammatory diseases)&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Currently on a weight-loss diet&#xD;
&#xD;
          -  BMI (body mass index) &lt; 25 or &gt; 30&#xD;
&#xD;
          -  Alcohol intake of greater than 2 drinks/day&#xD;
&#xD;
          -  Current use of prescription or over-the-counter medications, (Excluding oral&#xD;
             contraceptives and hormone-secreting IUDs), including use of aspirin or NSAIDs more&#xD;
             than 2 days per week&#xD;
&#xD;
          -  Abnormal renal, liver or metabolic test&#xD;
&#xD;
          -  Inability to swallow pills&#xD;
&#xD;
          -  Known allergy to shellfish&#xD;
&#xD;
          -  Not willing to take pills made from shellfish or animal sources&#xD;
&#xD;
          -  Intention to relocate out of study area within next 4 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>May 23, 2014</last_update_submitted>
  <last_update_submitted_qc>May 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2014</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>Inflammation</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/NCT01682694
org study id: 7798
nct id: NCT01682694
lead sponsor: 
has dmc: No
A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected
      by a reduction in serum C-reactive protein.
Use of glucosamine and chondroitin have been associated with reduced cancer and overall
      mortality. The aim of this study is to determine whether a common starting dose of
      glucosamine and chondroitin (1500 mg/d + 1200 mg/d, respectively) reduces systemic
      inflammation as reflected by a reduction in high sensitivity C-reactive protein.
allocation: Randomized
intervention model: Crossover Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: hsCRP
time frame: 1 year
description: hsCRP is a biomarker of systemic inflammation
measure: untargeted (exploratory) serum metabolomics (differences in small molecule abundance ratios)
time frame: 1 year
description: The mechanisms of action of glucosamine and chondroitin are currently unknown. Untargeted metabolomic assays of serum will be undertaken for exploratory analyses of potential effects of glucosamine and chondroitin. Significant differences in abundance ratios of small molecules between the intervention and placebo will be reported.
arm group label: Glucosamine and Chondroitin
arm group type: Experimental
description: Glucosamine and Chondroitin
arm group label: Placebo
arm group type: Placebo Comparator
description: Inactive ingredients
intervention type: Dietary Supplement
intervention name: Glucosamine and Chondroitin
description: Glucosamine (1500 mg) and Chondroitin (1200 mg)
arm group label: Glucosamine and Chondroitin
other name: Nutramax
intervention type: Dietary Supplement
intervention name: placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Inflammation