<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/NCT01687114</url>
  </required_header>
  <id_info>
    <org_study_id>HNRC2785</org_study_id>
    <nct_id>NCT01687114</nct_id>
  </id_info>
  <brief_title>Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products</brief_title>
  <official_title>Urinary Proanthocyanidin (PAC) A2 as a Biomarker of Compliance to Intake of Cranberry Products - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tufts University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol is a clinical trial to validate proanthocyanidin A2 (PAC-A2) as a useful marker&#xD;
      of cranberry intake. We hypothesize the consumption of this cranberry beverage in a&#xD;
      progressive dosing schedule will increase PAC-A2 excretion in urine. Five generally healthy,&#xD;
      nonsmoking, pre-menopausal women (absent major chronic diseases including cardiovascular,&#xD;
      endocrine, gastrointestinal, and renal conditions), age 20-40 years, with a body mass index&#xD;
      (BMI) of 18.5-25 kg/m2 will be recruited from the Boston area because sexually active women&#xD;
      in this age range are particularly vulnerable to urinary tract infection. Volunteers will be&#xD;
      asked to consume their assigned cranberry beverage at a dose of 8 oz/day according to a&#xD;
      weekly dosing schedule. Relevant clinical information and eleven 24-hour and morning spot&#xD;
      urine samples each will be collected from subjects during the study. Urinary PAC-A2&#xD;
      concentration will then be determined to validate if it can serve as a marker of compliance&#xD;
      of cranberry juice consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People who frequently eat whole grains, fruits and berries, vegetables, beans and legumes,&#xD;
      nuts, seeds, cocoa, tea, wine, and fruit or vegetable juices may have decreased risk of&#xD;
      diseases. It is believed that some of these health benefits are due to phytochemicals present&#xD;
      in these foods and beverages. Phytochemicals are nutrients that are naturally present in&#xD;
      plant-based foods and beverages. Recently, cranberry containing foods and beverages are&#xD;
      believed to prevent urinary tract infection. However, how cranberry decrease urinary tract&#xD;
      infection is not very clear. To better understand how phytochemicals in cranberries may&#xD;
      benefit health, we want to learn how they are absorbed and eliminated from the body. Thus,&#xD;
      the purpose of the main study is to see whether we can measure phytochemicals from&#xD;
      cranberries in health volunteers after they drink cranberry juice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proanthocyanidin A2</measure>
    <time_frame>24-hour urine and morning spot urine</time_frame>
    <description>proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Urinary Tract Infection</condition>
  <arm_group>
    <arm_group_label>cranberry juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>27% cranberry juice</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cranberry juice</intervention_name>
    <description>27% cranberry juice</description>
    <arm_group_label>cranberry juice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  generally healthy premenopausal women&#xD;
&#xD;
          -  aged 20-40 y&#xD;
&#xD;
          -  body mass index (BMI): 18.5-25 kg/m2&#xD;
&#xD;
          -  sexually active but not pregnant or planning to become pregnant&#xD;
&#xD;
          -  no advance plans to discontinue use of hormonal contraceptives if they are taken&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of medications known to affect lipid metabolism&#xD;
&#xD;
          -  History of a bilateral mastectomy&#xD;
&#xD;
          -  Use of medications known or suspected to influence blood pressure&#xD;
&#xD;
          -  cardiovascular diseases&#xD;
&#xD;
          -  Gastrointestinal diseases,&#xD;
&#xD;
          -  Renal or chronic kidney disease&#xD;
&#xD;
          -  Endocrine disorders&#xD;
&#xD;
          -  Rheumatologic diseases&#xD;
&#xD;
          -  Immune deficiency conditions&#xD;
&#xD;
          -  Active treatment for cancer of any type longer than 1 y&#xD;
&#xD;
          -  Systolic blood pressure &gt;139 mmHg and/or diastolic blood pressure &gt;89 mmHg&#xD;
&#xD;
          -  Regular use (more than 1x/wk) of any acid-lowering medications, laxatives (including&#xD;
             fiber supplements) or anti-diarrheal medications&#xD;
&#xD;
          -  Use of any antibiotics in the last month&#xD;
&#xD;
          -  Regular use of systemic steroids, oral or injectable&#xD;
&#xD;
          -  Gain or loss of more than 5% of body weight in the last 6 mo&#xD;
&#xD;
          -  Any history of or known allergies to cranberries or cranberry products&#xD;
&#xD;
          -  Regular use of any dietary supplements containing vitamins, minerals, herbal or other&#xD;
             plant-based preparations, fish oil supplements or homeopathic remedies.&#xD;
&#xD;
          -  Usual daily ethanol intake of equal and more than 2 drinks&#xD;
&#xD;
          -  Cigarette smoking and/or nicotine replacement use.&#xD;
&#xD;
          -  Strict vegetarians (vegans)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Infrequent (&lt;3/wk) or excessive (&gt;3/d) number of regular bowel movements&#xD;
&#xD;
          -  Inability to discontinue or refrain from ASA/NSAID or Tylenol use for 72 h prior to&#xD;
             and for the duration of testing on Visits 2-13&#xD;
&#xD;
          -  Participation in a clinical research trial within 60 d of their enrollment visit&#xD;
             (Visit 2)&#xD;
&#xD;
          -  Specific laboratory blood or urine analysis parameters of: Creatinine &gt;1.5 mg/dL,&#xD;
             Electrolytes, calcium, phosphorous - out of normal ranges, ALT and AST &gt;1.5 nmol,&#xD;
             Total bilirubin - above normal range, Fasting glucose ≥126 mg/dL, Total cholesterol&#xD;
             &gt;239 mg/dL, Triglycerides ≥300 mg/dL, CBC: HCT &lt;32% for females, below normal range&#xD;
             for males, WBC, PLT - out of normal range, hematuria, proteinuria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oliver Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jean Mayer USDA Human Nutrition Research Center on Aging</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>November 13, 2014</results_first_submitted>
  <results_first_submitted_qc>December 10, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 15, 2014</results_first_posted>
  <last_update_submitted>December 10, 2014</last_update_submitted>
  <last_update_submitted_qc>December 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tufts University</investigator_affiliation>
    <investigator_full_name>Oliver Chen</investigator_full_name>
    <investigator_title>Research Scientist II</investigator_title>
  </responsible_party>
  <keyword>compliance, proanthocyanidin, phenoic acids, cranberry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cranberry Juice</title>
          <description>27% cranberry juice&#xD;
cranberry juice: 27% cranberry juice</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cranberry Juice</title>
          <description>27% cranberry juice&#xD;
cranberry juice: 27% cranberry juice</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.6" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proanthocyanidin A2</title>
        <description>proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.</description>
        <time_frame>24-hour urine and morning spot urine</time_frame>
        <population>The subjects included 5 generally healthy premenopausal women, age 20-40 y, with a body mass index (BMI) ranging from 18.5 to 25 kg/m2. The specific operational criteria used to assess eligibility included: age, BMI, premenopausal status, not pregnant or planning to become pregnant.</population>
        <group_list>
          <group group_id="O1">
            <title>Cranberry Juice</title>
            <description>27% cranberry juice&#xD;
cranberry juice: 27% cranberry juice</description>
          </group>
        </group_list>
        <measure>
          <title>Proanthocyanidin A2</title>
          <description>proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.</description>
          <population>The subjects included 5 generally healthy premenopausal women, age 20-40 y, with a body mass index (BMI) ranging from 18.5 to 25 kg/m2. The specific operational criteria used to assess eligibility included: age, BMI, premenopausal status, not pregnant or planning to become pregnant.</population>
          <units>ng/mg creatinine</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24 h urine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>morning spot urine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The whole intervention duration was 8 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cranberry Juice</title>
          <description>27% cranberry juice&#xD;
cranberry juice: 27% cranberry juice</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Oliver Chen</name_or_title>
      <organization>Tufts University</organization>
      <phone>617-5563128</phone>
      <email>oliver.chen@tufts.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01687114
org study id: HNRC2785
nct id: NCT01687114
lead sponsor: 
has dmc: No
This protocol is a clinical trial to validate proanthocyanidin A2 (PAC-A2) as a useful marker
      of cranberry intake. We hypothesize the consumption of this cranberry beverage in a
      progressive dosing schedule will increase PAC-A2 excretion in urine. Five generally healthy,
      nonsmoking, pre-menopausal women (absent major chronic diseases including cardiovascular,
      endocrine, gastrointestinal, and renal conditions), age 20-40 years, with a body mass index
      (BMI) of 18.5-25 kg/m2 will be recruited from the Boston area because sexually active women
      in this age range are particularly vulnerable to urinary tract infection. Volunteers will be
      asked to consume their assigned cranberry beverage at a dose of 8 oz/day according to a
      weekly dosing schedule. Relevant clinical information and eleven 24-hour and morning spot
      urine samples each will be collected from subjects during the study. Urinary PAC-A2
      concentration will then be determined to validate if it can serve as a marker of compliance
      of cranberry juice consumption.
People who frequently eat whole grains, fruits and berries, vegetables, beans and legumes,
      nuts, seeds, cocoa, tea, wine, and fruit or vegetable juices may have decreased risk of
      diseases. It is believed that some of these health benefits are due to phytochemicals present
      in these foods and beverages. Phytochemicals are nutrients that are naturally present in
      plant-based foods and beverages. Recently, cranberry containing foods and beverages are
      believed to prevent urinary tract infection. However, how cranberry decrease urinary tract
      infection is not very clear. To better understand how phytochemicals in cranberries may
      benefit health, we want to learn how they are absorbed and eliminated from the body. Thus,
      the purpose of the main study is to see whether we can measure phytochemicals from
      cranberries in health volunteers after they drink cranberry juice.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Proanthocyanidin A2
time frame: 24-hour urine and morning spot urine
description: proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.
arm group label: cranberry juice
arm group type: Experimental
description: 27% cranberry juice
intervention type: Other
intervention name: cranberry juice
description: 27% cranberry juice
arm group label: cranberry juice
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Oliver Chen, PhD
role: Principal Investigator
affiliation: Tufts University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Tufts University
investigator full name: Oliver Chen
investigator title: Research Scientist II
mesh term: Urinary Tract Infections
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 