<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/NCT03827161</url>
  </required_header>
  <id_info>
    <org_study_id>RG1001578</org_study_id>
    <secondary_id>NCI-2018-02647</secondary_id>
    <nct_id>NCT03827161</nct_id>
  </id_info>
  <brief_title>Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients</brief_title>
  <official_title>GLANCE 2 - Glucosamine and Chondroitin (G&amp;C) Effects Study</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies glucosamine and chondroitin in preventing inflammation in overweight&#xD;
      patients. Chronic inflammation contributes to cancer formation, and biomarkers of&#xD;
      inflammation have been associated with cancer risk. Glucosamine and chondroitin may prevent&#xD;
      inflammation and this trial may help identify the bacteria that help process them in the gut.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of glucosamine sulfate/chondroitin sulfate tablet (G&amp;C) on gut microbial community modulation</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>shifts in the bacterial communities within person based on clustering of operational taxonomic units (OTU) at 97% utilizing principal coordinate analysis [PCOA]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of G&amp;C on serum C-reactive protein (CRP)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>evaluated using a generalized estimating equation which accounts for variation due to repeated measures within an individual</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Healthy Subject</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Arm I (glucosamine sulfate/chondroitin sulfate tablet)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive glucosamine sulfate/chondroitin sulfate tablet PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm II.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive placebo PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glucosamine</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm I (glucosamine sulfate/chondroitin sulfate tablet)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm II (placebo)</arm_group_label>
    <other_name>PLCB</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Individuals from the Greater Seattle area who are overweight (body mass index [BMI] of&#xD;
        25-32.5 kg/m^2)&#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; 32.5 kg/m^2&#xD;
&#xD;
          -  Alcohol intake of greater than 2 drinks/day (2 drinks being equivalent to 720 ml beer,&#xD;
             240 ml wine or 90 ml spirits)&#xD;
&#xD;
          -  Current use of prescription or over-the-counter medications other than oral&#xD;
             contraceptives and hormone secreting intrauterine device (IUD)s, multivitamin pills or&#xD;
             infrequent use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), or use of&#xD;
             aspirin or NSAIDs more 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 2 months&#xD;
&#xD;
          -  Any antibiotic use in the past 6 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>
  <overall_official>
    <last_name>Johanna Lampe</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutchinson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</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>January 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</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>Overweight</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/NCT03827161
org study id: RG1001578
secondary id: NCI-2018-02647
nct id: NCT03827161
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This trial studies glucosamine and chondroitin in preventing inflammation in overweight
      patients. Chronic inflammation contributes to cancer formation, and biomarkers of
      inflammation have been associated with cancer risk. Glucosamine and chondroitin may prevent
      inflammation and this trial may help identify the bacteria that help process them in the gut.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation
time frame: Up to 2 years
description: shifts in the bacterial communities within person based on clustering of operational taxonomic units (OTU) at 97% utilizing principal coordinate analysis [PCOA]).
measure: Effects of G&C on serum C-reactive protein (CRP)
time frame: Up to 2 years
description: evaluated using a generalized estimating equation which accounts for variation due to repeated measures within an individual
arm group label: Arm I (glucosamine sulfate/chondroitin sulfate tablet)
arm group type: Experimental
description: Patients receive glucosamine sulfate/chondroitin sulfate tablet PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm II.
arm group label: Arm II (placebo)
arm group type: Placebo Comparator
description: Patients receive placebo PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm I.
intervention type: Dietary Supplement
intervention name: Glucosamine
description: Given PO
arm group label: Arm I (glucosamine sulfate/chondroitin sulfate tablet)
intervention type: Other
intervention name: Placebo
description: Given PO
arm group label: Arm II (placebo)
other name: PLCB
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Johanna Lampe
role: Principal Investigator
affiliation: Fred Hutchinson Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No