<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/NCT01734070</url>
  </required_header>
  <id_info>
    <org_study_id>FL40</org_study_id>
    <nct_id>NCT01734070</nct_id>
  </id_info>
  <brief_title>Role of Cherry Consumption in Reducing Risk Factors for Chronic Inflammatory Diseases</brief_title>
  <official_title>Role of Cherry Consumption in Reducing Risk Factors for Human Chronic Inflammatory Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA, Western Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California Cherry Board</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>USDA, Western Human Nutrition Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to examine if chronic cherry consumption will decrease lipid&#xD;
      peroxidation and serum concentration of inflammatory markers in human subjects with elevated&#xD;
      serum C reactive protein (CRP), and to examine the relationship between serum concentrations&#xD;
      of CRP and polyphenols. The investigators hypothesize that cherry consumption will reduce&#xD;
      serum concentration of inflammatory markers, including CRP, inflammatory cytokines and&#xD;
      adhesion molecules.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will last a total of 64 days with three different metabolic periods. First 8 days&#xD;
      will be period 1, when base line fasting blood samples will be collected on day 1 and 8. For&#xD;
      the next 28 days (period 2 or intervention period) subjects will supplement their diets with&#xD;
      280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.&#xD;
      We will prefer that the subjects split the cherries into three equal portions and consume one&#xD;
      with each meal; however, this will not be mandatory. Subjects will be asked to record all&#xD;
      foods and drinks consumed for three 24-hr periods during the study. Fasting blood samples&#xD;
      will be drawn on study days 22 and 36 (14 and 28 day after the start of cherry consumption).&#xD;
      The third period of 28 days will be post-intervention, when the subjects will return to their&#xD;
      normal diets without cherries. Post-intervention blood samples will be drawn on study day 64.&#xD;
      All blood draws will follow a 12-hour fast. Blood samples will be processed within one hour&#xD;
      of draw and the plasma stored frozen in different aliquots, until analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2003</start_date>
  <completion_date type="Actual">September 2004</completion_date>
  <primary_completion_date type="Actual">September 2003</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>Change in lipid peroxidation</measure>
    <time_frame>baseline, day 36, and day 64</time_frame>
    <description>The study will last a total of 64 days with three different metabolic periods. First 8 days will be period 1, when baseline fasting blood samples will be collected on day 1 and 8. For the next 28 days (period 2 or intervention period) subjects will supplement their diets with 280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. Fasting blood samples will be drawn on study day 36. The third period of 28 days will be post-intervention, when the subjects will return to their normal diets without cherries. Post-intervention blood samples will be drawn on study day 64.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in serum concentration of inflammatory markers</measure>
    <time_frame>baseline, day 36 and day 64</time_frame>
    <description>The study will last a total of 64 days with three different metabolic periods. First 8 days will be period 1, when baseline fasting blood samples will be collected on day 1 and 8. For the next 28 days (period 2 or intervention period) subjects will supplement their diets with 280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. Fasting blood samples will be drawn on study day 36. The third period of 28 days will be post-intervention, when the subjects will return to their normal diets without cherries. Post-intervention blood samples will be drawn on study day 64.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Inflammation</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Cherry consumption</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers will supplement their diets with 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. We will prefer that the subjects split the cherries into three equal portions and consume one with each meal; however, this will not be mandatory.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cherry consumption</intervention_name>
    <description>Volunteers will eat 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.</description>
    <arm_group_label>Cherry consumption</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women&#xD;
&#xD;
          -  45-65 years of age&#xD;
&#xD;
          -  serum CRP concentrations between 3-25 mg/L&#xD;
&#xD;
          -  BMI &lt; 35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 35 kg/m2&#xD;
&#xD;
          -  current infection&#xD;
&#xD;
          -  taking anti-inflammatory medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Darshan Kelley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USDA, ARS, Western Human Nutrition Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USDA, ARS, Western Human Nutrition Research Center</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ars.usda.gov/Main/docs.htm?docid=11240</url>
    <description>USDA, ARS, WHNRC</description>
  </link>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>February 7, 2013</last_update_submitted>
  <last_update_submitted_qc>February 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anthocyanins</keyword>
  <keyword>catechins</keyword>
  <keyword>chlorogenic acid</keyword>
  <keyword>flavanol glycosides</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <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/NCT01734070
org study id: FL40
nct id: NCT01734070
lead sponsor: 
collaborator: 
has dmc: No
The goal of this study is to examine if chronic cherry consumption will decrease lipid
      peroxidation and serum concentration of inflammatory markers in human subjects with elevated
      serum C reactive protein (CRP), and to examine the relationship between serum concentrations
      of CRP and polyphenols. The investigators hypothesize that cherry consumption will reduce
      serum concentration of inflammatory markers, including CRP, inflammatory cytokines and
      adhesion molecules.
The study will last a total of 64 days with three different metabolic periods. First 8 days
      will be period 1, when base line fasting blood samples will be collected on day 1 and 8. For
      the next 28 days (period 2 or intervention period) subjects will supplement their diets with
      280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.
      We will prefer that the subjects split the cherries into three equal portions and consume one
      with each meal; however, this will not be mandatory. Subjects will be asked to record all
      foods and drinks consumed for three 24-hr periods during the study. Fasting blood samples
      will be drawn on study days 22 and 36 (14 and 28 day after the start of cherry consumption).
      The third period of 28 days will be post-intervention, when the subjects will return to their
      normal diets without cherries. Post-intervention blood samples will be drawn on study day 64.
      All blood draws will follow a 12-hour fast. Blood samples will be processed within one hour
      of draw and the plasma stored frozen in different aliquots, until analysis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in lipid peroxidation
time frame: baseline, day 36, and day 64
description: The study will last a total of 64 days with three different metabolic periods. First 8 days will be period 1, when baseline fasting blood samples will be collected on day 1 and 8. For the next 28 days (period 2 or intervention period) subjects will supplement their diets with 280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. Fasting blood samples will be drawn on study day 36. The third period of 28 days will be post-intervention, when the subjects will return to their normal diets without cherries. Post-intervention blood samples will be drawn on study day 64.
measure: Change in serum concentration of inflammatory markers
time frame: baseline, day 36 and day 64
description: The study will last a total of 64 days with three different metabolic periods. First 8 days will be period 1, when baseline fasting blood samples will be collected on day 1 and 8. For the next 28 days (period 2 or intervention period) subjects will supplement their diets with 280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. Fasting blood samples will be drawn on study day 36. The third period of 28 days will be post-intervention, when the subjects will return to their normal diets without cherries. Post-intervention blood samples will be drawn on study day 64.
arm group label: Cherry consumption
arm group type: Experimental
description: Volunteers will supplement their diets with 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories. We will prefer that the subjects split the cherries into three equal portions and consume one with each meal; however, this will not be mandatory.
intervention type: Other
intervention name: Cherry consumption
description: Volunteers will eat 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.
arm group label: Cherry consumption
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Darshan Kelley, PhD
role: Principal Investigator
affiliation: USDA, ARS, Western Human Nutrition Research Center
facility: 
country: United States
url: http://www.ars.usda.gov/Main/docs.htm?docid=11240
description: USDA, ARS, WHNRC
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Inflammation