<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/NCT04497077</url>
  </required_header>
  <id_info>
    <org_study_id>801765</org_study_id>
    <nct_id>NCT04497077</nct_id>
  </id_info>
  <brief_title>Comparison of Acute Tart Cherry Supplement Formulation and Dose on Inflammation and Oxidative Capacity</brief_title>
  <official_title>Comparison of Acute Tart Cherry Supplement Formulation and Dose on Inflammation and Oxidative Capacity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Marywood University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio University</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>
      A comparison of acute tart cherry formations (juice vs. powdered) and doses (single vs. twice&#xD;
      daily) on inflammation and oxidative capacity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomly allocated to a group: one tart cherry capsule daily, two tart&#xD;
      cherry capsules daily, one 8oz. bottle of tart cherry juice daily, two 8oz. bottles of tart&#xD;
      cherry juice taken 8 hours apart, one placebo pill, and one 8oz. bottle of placebo.&#xD;
      Participants will arrive to the lab at 8 am after an overnight fast of 10 hours. They will&#xD;
      provide a blood sample and then ingest their study treatment. Participants will stay in the&#xD;
      lab for a further 2 hours for additional blood draws then return to the lab in 6 hours for&#xD;
      another blood draw. At this time if they are in a twice daily group they will receive their&#xD;
      second treatment for the day. All participants will come back to the lab 24 hours later where&#xD;
      they will give a blood sample and receive their next treatment. If they are in the twice&#xD;
      daily group they will be provided with their next dose and given instructions to consume it&#xD;
      in 8 hours. Participants will arrive 24 hours later for a final blood draw with no&#xD;
      supplementation.&#xD;
&#xD;
      Blood samples will be measured pre-ingestion, 1 hour, 2 hours, 8 hours, 24 hours and 48 hours&#xD;
      post-ingestion. Samples will be analyzed for plasma oxygen radical absorbance capacity&#xD;
      (ORAC), uric acid (UA), and C-reactive protein (CRP).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2015</start_date>
  <completion_date type="Actual">May 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2016</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in c-reactive protein</measure>
    <time_frame>1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion</time_frame>
    <description>c-reactive protein (mg/L) measured via assay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in uric acid</measure>
    <time_frame>1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion</time_frame>
    <description>uric acid (mg/dL) measured via assay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in oxidative capacity</measure>
    <time_frame>1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion</time_frame>
    <description>oxygen radical absorbance capacity (uM Trolox equivalents) measured via assay</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Inflammation</condition>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>single dose tart cherry capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose tart cherry capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>double dose tart cherry capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>double dose tart cherry capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>single dose tart cherry juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose tart cherry juice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>double dose tart cherry juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>double dose tart cherry juice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>single placebo capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single placebo capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>single placebo juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single placebo juice</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>tart cherry</intervention_name>
    <description>Either tart cherry juice or freeze dried powdered tart cherry in capsule was given</description>
    <arm_group_label>double dose tart cherry capsule</arm_group_label>
    <arm_group_label>double dose tart cherry juice</arm_group_label>
    <arm_group_label>single dose tart cherry capsule</arm_group_label>
    <arm_group_label>single dose tart cherry juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>either cornstarch capsule or kool-aid</description>
    <arm_group_label>single placebo capsule</arm_group_label>
    <arm_group_label>single placebo juice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  free of cardiovascular, metabolic and inflammatory conditions&#xD;
&#xD;
          -  non-smokers&#xD;
&#xD;
          -  no known allergy to cherries or cherry juice&#xD;
&#xD;
          -  not be taking food supplements (turmeric/curcumin, cherry products, greens, etc.).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  quit smoking less than one year ago.&#xD;
&#xD;
          -  currently being treated for arthritis or an inflammatory condition.&#xD;
&#xD;
          -  currently being treated for uncontrolled cardiovascular disease, high blood pressure,&#xD;
             diabetes, fibromyalgia, or irritable bowel syndrome.&#xD;
&#xD;
          -  pregnant.&#xD;
&#xD;
          -  regularly consume cherries or are allergic to cherries or dairy.&#xD;
&#xD;
          -  currently use anti-inflammatory medications,&#xD;
&#xD;
          -  have used corticosteroids in the last two months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio University</investigator_affiliation>
    <investigator_full_name>Angela Hillman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>upon request</ipd_description>
  </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/NCT04497077
org study id: 801765
nct id: NCT04497077
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A comparison of acute tart cherry formations (juice vs. powdered) and doses (single vs. twice
      daily) on inflammation and oxidative capacity.
Participants will be randomly allocated to a group: one tart cherry capsule daily, two tart
      cherry capsules daily, one 8oz. bottle of tart cherry juice daily, two 8oz. bottles of tart
      cherry juice taken 8 hours apart, one placebo pill, and one 8oz. bottle of placebo.
      Participants will arrive to the lab at 8 am after an overnight fast of 10 hours. They will
      provide a blood sample and then ingest their study treatment. Participants will stay in the
      lab for a further 2 hours for additional blood draws then return to the lab in 6 hours for
      another blood draw. At this time if they are in a twice daily group they will receive their
      second treatment for the day. All participants will come back to the lab 24 hours later where
      they will give a blood sample and receive their next treatment. If they are in the twice
      daily group they will be provided with their next dose and given instructions to consume it
      in 8 hours. Participants will arrive 24 hours later for a final blood draw with no
      supplementation.

      Blood samples will be measured pre-ingestion, 1 hour, 2 hours, 8 hours, 24 hours and 48 hours
      post-ingestion. Samples will be analyzed for plasma oxygen radical absorbance capacity
      (ORAC), uric acid (UA), and C-reactive protein (CRP).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Change in c-reactive protein
time frame: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
description: c-reactive protein (mg/L) measured via assay
measure: Change in uric acid
time frame: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
description: uric acid (mg/dL) measured via assay
measure: Change in oxidative capacity
time frame: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
description: oxygen radical absorbance capacity (uM Trolox equivalents) measured via assay
arm group label: single dose tart cherry capsule
arm group type: Experimental
description: single dose tart cherry capsule
arm group label: double dose tart cherry capsule
arm group type: Experimental
description: double dose tart cherry capsule
arm group label: single dose tart cherry juice
arm group type: Experimental
description: single dose tart cherry juice
arm group label: double dose tart cherry juice
arm group type: Experimental
description: double dose tart cherry juice
arm group label: single placebo capsule
arm group type: Experimental
description: single placebo capsule
arm group label: single placebo juice
arm group type: Experimental
description: single placebo juice
intervention type: Dietary Supplement
intervention name: tart cherry
description: Either tart cherry juice or freeze dried powdered tart cherry in capsule was given
arm group label: double dose tart cherry capsule
arm group label: double dose tart cherry juice
arm group label: single dose tart cherry capsule
arm group label: single dose tart cherry juice
intervention type: Dietary Supplement
intervention name: placebo
description: either cornstarch capsule or kool-aid
arm group label: single placebo capsule
arm group label: single placebo juice
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Ohio University
investigator full name: Angela Hillman
investigator title: Assistant Professor
mesh term: Inflammation
sharing ipd: No
ipd description: upon request