<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/NCT03772808</url>
  </required_header>
  <id_info>
    <org_study_id>OBVIO-LYC-001</org_study_id>
    <nct_id>NCT03772808</nct_id>
  </id_info>
  <brief_title>Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)</brief_title>
  <official_title>Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LycoRed Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LycoRed Ltd.</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 study will evaluate LycoComfort™ supplementation in alleviating symptoms associated with&#xD;
      LUTS, BPH, and general prostate concerns.&#xD;
&#xD;
      Inflammation, oxidative stress and androgenic activity in the prostate are proven catalysts&#xD;
      of BPH, ultimately leading to increased prostate cell proliferation. The once-daily&#xD;
      supplement LycoComfort™, will be under investigation for symptom relief and will be taken by&#xD;
      participants for a duration of 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      LycoComfort™ is a dietary supplement containing tomato extract and phytosterols, ingredients&#xD;
      that have been associated with relief of symptoms associated with general prostate discomfort&#xD;
      and Lower Urinary Tract Symptoms (LUTS).&#xD;
&#xD;
      The purpose of this study is to evaluate changes in these symptoms after taking this&#xD;
      supplement daily for 12 weeks.&#xD;
&#xD;
      Although it was not until the latter part of the twenties century that investigators began to&#xD;
      explore the importance of lycopene, the benefits of this natural carotenoid are well studied.&#xD;
      A number of clinical trials have shown lycopene to be effectual for alleviating prostate&#xD;
      discomfort, symptoms of BPH and LUTS.&#xD;
&#xD;
      The American Urological Association estimates that 90% of men between 45 and 80 years of age&#xD;
      suffer some symptoms of LUTS. Several pathophysiological mechanisms are believed to lead to&#xD;
      LUTS and BPH, including oxidative damage, inflammation and sympathetic nervous system issues.&#xD;
      High blood lycopene concentrations have been suggested in epidemiological trials to be&#xD;
      associated with decreases in oxidative stress and contributions to disease prevention&#xD;
      overall. Also, clinical trials have shown that higher levels of lycopene in the blood are&#xD;
      associated with a reduced risk of prostate cancer, as well as other inflammatory conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2018</start_date>
  <completion_date type="Actual">June 15, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with a change in International Prostate Symptom Score (I-PSS)</measure>
    <time_frame>Enrollment to 12 weeks</time_frame>
    <description>Change from enrollment to week 12 in prostate symptoms, measured by the Prostate Symptom Score questionnaire (I-PSS) ranged 1-35 points (1-7: Mild 8-19: Moderate 20-35: Severe).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a significant improvement in International Prostate Symptom Score (I-PSS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of subjects with a clinically significant improvement in International Prostate Symptom Score (I-PSS) at week 12, defined as an improvement of at least 3 points in a 1-35 point scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a change in Core Lower Urinary Tract Symptom Score (CLSS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from enrollment to week 12 in urinary symptoms, measured by Core Lower Urinary Tract Symptom Score (CLSS), ranged 1-31 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction from treatment evaluated by &quot;User satisfaction questionnaire&quot;</measure>
    <time_frame>12 weeks</time_frame>
    <description>Subject satisfaction with the LycoComfort™ supplement, as derived from responses to &quot;User satisfaction Questionnaire&quot; ( 5 point Likert scale, ranged 8-45 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Adverse events (AEs) reported during the treatment period and classified by the Investigator as to intensity, relationship to study procedures, and seriousness</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of patients with a change in Brief Sexual Function Index (BSFI) score</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from enrollment to week 12 in sexual function, measured by Brief Sexual Function Index (BSFI) score ( ranged 0-44 points)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>BPH</condition>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>Lycocomfort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The once-daily supplement LycoComfort™ is a combination of lycopene and beta-sitosterol, a chemically defined extract of phytosterols with beta-sitosterol as the main component,</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lycocomfort</intervention_name>
    <description>Evaluate of the perceived efficacy of LycoComfort™ supplements in alleviating symptoms associated with lower urinary tract symptoms (LUTS) and general prostate discomfort over the duration of 12 weeks intervention</description>
    <arm_group_label>Lycocomfort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males, age 40 and older&#xD;
&#xD;
          -  A score of 8 or greater on a self-administered I-PSS test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute or chronic prostatitis&#xD;
&#xD;
          -  Acute urinary retention&#xD;
&#xD;
          -  Allergy or sensitivity to any of the test product components (tomato [lycopene] or&#xD;
             beta-sitosterol)&#xD;
&#xD;
          -  Cancer of the prostate (PCa) or other cancers, current or a history of PCa&#xD;
&#xD;
          -  Chronic diseases of the kidneys and/or liver&#xD;
&#xD;
          -  Hematuria of unknown etiology&#xD;
&#xD;
          -  Infection or malfunction of the urinary tract&#xD;
&#xD;
          -  Inflammatory diseases of the urogenital tract&#xD;
&#xD;
          -  Medication, herbal supplementation or other substance use for the treatment of urinary&#xD;
             symptoms, BPH/LUTS, or erectile dysfunction, including medications which may affect&#xD;
             hormonal status within 30 days before screening. These may include, but are not&#xD;
             limited to: Sildenafil/Viagra; Tadalafil/Cialis; Vardenafil/Levitra; &quot;Herbal Viagra&quot;;&#xD;
             Alpha-Blockers; Oral Steroids, Spironolactone or Testosterone&#xD;
&#xD;
          -  Previous radiotherapy of prostate&#xD;
&#xD;
          -  Previous surgery of the prostate, bladder or urethra&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Parth Shah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ObvioHealth</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Obvio Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>June 30, 2019</last_update_submitted>
  <last_update_submitted_qc>June 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 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>Lower Urinary Tract Symptoms</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/NCT03772808
org study id: OBVIO-LYC-001
nct id: NCT03772808
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate LycoComfort™ supplementation in alleviating symptoms associated with
      LUTS, BPH, and general prostate concerns.

      Inflammation, oxidative stress and androgenic activity in the prostate are proven catalysts
      of BPH, ultimately leading to increased prostate cell proliferation. The once-daily
      supplement LycoComfort™, will be under investigation for symptom relief and will be taken by
      participants for a duration of 12 weeks.
LycoComfort™ is a dietary supplement containing tomato extract and phytosterols, ingredients
      that have been associated with relief of symptoms associated with general prostate discomfort
      and Lower Urinary Tract Symptoms (LUTS).

      The purpose of this study is to evaluate changes in these symptoms after taking this
      supplement daily for 12 weeks.

      Although it was not until the latter part of the twenties century that investigators began to
      explore the importance of lycopene, the benefits of this natural carotenoid are well studied.
      A number of clinical trials have shown lycopene to be effectual for alleviating prostate
      discomfort, symptoms of BPH and LUTS.

      The American Urological Association estimates that 90% of men between 45 and 80 years of age
      suffer some symptoms of LUTS. Several pathophysiological mechanisms are believed to lead to
      LUTS and BPH, including oxidative damage, inflammation and sympathetic nervous system issues.
      High blood lycopene concentrations have been suggested in epidemiological trials to be
      associated with decreases in oxidative stress and contributions to disease prevention
      overall. Also, clinical trials have shown that higher levels of lycopene in the blood are
      associated with a reduced risk of prostate cancer, as well as other inflammatory conditions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of patients with a change in International Prostate Symptom Score (I-PSS)
time frame: Enrollment to 12 weeks
description: Change from enrollment to week 12 in prostate symptoms, measured by the Prostate Symptom Score questionnaire (I-PSS) ranged 1-35 points (1-7: Mild 8-19: Moderate 20-35: Severe).
measure: Number of patients with a significant improvement in International Prostate Symptom Score (I-PSS)
time frame: 12 weeks
description: The number of subjects with a clinically significant improvement in International Prostate Symptom Score (I-PSS) at week 12, defined as an improvement of at least 3 points in a 1-35 point scale.
measure: Number of patients with a change in Core Lower Urinary Tract Symptom Score (CLSS)
time frame: 12 weeks
description: Change from enrollment to week 12 in urinary symptoms, measured by Core Lower Urinary Tract Symptom Score (CLSS), ranged 1-31 points.
measure: Satisfaction from treatment evaluated by "User satisfaction questionnaire"
time frame: 12 weeks
description: Subject satisfaction with the LycoComfort™ supplement, as derived from responses to "User satisfaction Questionnaire" ( 5 point Likert scale, ranged 8-45 points).
measure: Adverse events (AEs)
time frame: 12 weeks
description: Adverse events (AEs) reported during the treatment period and classified by the Investigator as to intensity, relationship to study procedures, and seriousness
measure: Number of patients with a change in Brief Sexual Function Index (BSFI) score
time frame: 12 weeks
description: Change from enrollment to week 12 in sexual function, measured by Brief Sexual Function Index (BSFI) score ( ranged 0-44 points)
arm group label: Lycocomfort
arm group type: Experimental
description: The once-daily supplement LycoComfort™ is a combination of lycopene and beta-sitosterol, a chemically defined extract of phytosterols with beta-sitosterol as the main component,
intervention type: Dietary Supplement
intervention name: Lycocomfort
description: Evaluate of the perceived efficacy of LycoComfort™ supplements in alleviating symptoms associated with lower urinary tract symptoms (LUTS) and general prostate discomfort over the duration of 12 weeks intervention
arm group label: Lycocomfort
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Parth Shah, MD
role: Principal Investigator
affiliation: ObvioHealth
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lower Urinary Tract Symptoms
sharing ipd: No