<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/NCT01677169</url>
  </required_header>
  <id_info>
    <org_study_id>TNI-UIC-01</org_study_id>
    <nct_id>NCT01677169</nct_id>
  </id_info>
  <brief_title>Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers</brief_title>
  <official_title>Double Blind, Randomized, Placebo-controlled Clinical Trial of the Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Current Heavy Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tahitian Noni International, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tahitian Noni International, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH)&#xD;
      and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral&#xD;
      blood lymphocytes of cigarette smokers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2000</start_date>
  <completion_date type="Actual">August 2006</completion_date>
  <primary_completion_date type="Actual">November 2005</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LOOH and MDA-DNA adducts</measure>
    <time_frame>1 month</time_frame>
    <description>LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>1 month</time_frame>
    <description>Adverse health events</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">317</enrollment>
  <condition>DNA Damage</condition>
  <arm_group>
    <arm_group_label>59 mL noni juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ingestion of 59 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) twice daily (118 mL daily total) for 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ingestion of 59 mL of placebo (mixture of grape and blueberry juices and natural cheese flavor) twice daily (118 mL daily total) for 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>29.5 mL noni dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ingestion of 29.5 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) daily for 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Noni juice</intervention_name>
    <description>Ingestion of noni juice, a source of iridoids, daily for 30 days.</description>
    <arm_group_label>29.5 mL noni dose</arm_group_label>
    <arm_group_label>59 mL noni juice</arm_group_label>
    <other_name>Tahitian Noni® Juice</other_name>
    <other_name>Tahitian Noni® Original Bioactive</other_name>
    <other_name>Thrive Adaptogenics Original</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;
          -  18 to 65 years in age, smoker of more than 20 cigarettes per day, a smoking history&#xD;
             exceeding one year, and willing to complete a one month trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concurrent use, or use in the previous three months, of prescription medication or&#xD;
             antioxidant vitamins&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mian-ying Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois College of Medicine at Rockford</name>
      <address>
        <city>Rockford</city>
        <state>Illinois</state>
        <zip>61107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01677169
org study id: TNI-UIC-01
nct id: NCT01677169
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH)
      and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral
      blood lymphocytes of cigarette smokers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: LOOH and MDA-DNA adducts
time frame: 1 month
description: LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.
measure: adverse events
time frame: 1 month
description: Adverse health events
arm group label: 59 mL noni juice
arm group type: Experimental
description: Ingestion of 59 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) twice daily (118 mL daily total) for 30 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Ingestion of 59 mL of placebo (mixture of grape and blueberry juices and natural cheese flavor) twice daily (118 mL daily total) for 30 days.
arm group label: 29.5 mL noni dose
arm group type: Experimental
description: Ingestion of 29.5 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) daily for 30 days.
intervention type: Dietary Supplement
intervention name: Noni juice
description: Ingestion of noni juice, a source of iridoids, daily for 30 days.
arm group label: 29.5 mL noni dose
arm group label: 59 mL noni juice
other name: Tahitian Noni® Juice
other name: Tahitian Noni® Original Bioactive
other name: Thrive Adaptogenics Original
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mian-ying Wang, MD
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
responsible party type: Sponsor