<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/NCT04467372</url>
  </required_header>
  <id_info>
    <org_study_id>18-F-13</org_study_id>
    <nct_id>NCT04467372</nct_id>
  </id_info>
  <brief_title>Tart Cherry Supplementation &amp; Gut Microbiome and Inflammation</brief_title>
  <official_title>The Effects Supplementation of Tart Cherry or Placebo on the Gut Microbiome, Inflammation, Oxidative Stress, and Health-related Outcomes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      There has been a rapid increase in researching the use of tart cherry supplements in the past&#xD;
      5 years, particularly for inflammatory conditions. Many formulations of cherry supplements&#xD;
      exist, however there has been no comparison between these different types. This is&#xD;
      particularly important in the realm of inflammation research because sugar is known to&#xD;
      increase the inflammatory response. The pill form of cherry supplementation has no added&#xD;
      sugar and is naturally low in sugar (&lt; 1g) while the juice form is higher from added sugar.&#xD;
      Recent work indicates tart cherry consumption can change gut microbiota, which may modify&#xD;
      inflammation. The purpose of this study is to look at the effects of taking a cherry&#xD;
      supplement, either in capsule or juice form, on the gut microbiome, inflammation, and&#xD;
      health-related variables such as blood pressure, glucose regulation and sleep quality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will consume a tart cherry or placebo product for 30 days and attend 5 visits in&#xD;
      the Exercise Physiology Lab at Ohio University over the 30 day period. They will self-collect&#xD;
      a stool sample at baseline, 14 days and 30 days after supplementation. Blood samples will be&#xD;
      taken at baseline, 7 days, 14 days, and 30 days after supplementation. Throughout the study&#xD;
      participates will rate symptoms (stomach, head, etc.), pain and sleep quality using an online&#xD;
      survey for which the link will be emailed. Participants will maintain normal diet and&#xD;
      exercise routine and to track these for the duration of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 16, 2019</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>Changes in inflammation measured via tumor necrosis factor alpha (pg/mL)</measure>
    <time_frame>baseline, 7 days, 14 days, and 30 days post supplementation.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in inflammation measured via erythrocyte sedimentation rate (mm/hour)</measure>
    <time_frame>baseline, 7 days, 14 days, and 30 days post supplementation.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in inflammation measured via c-reactive protein (mg/L) and uric acid (mg/dL).</measure>
    <time_frame>baseline, 7 days, 14 days, and 30 days post supplementation.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in glucose regulation assessed via plasma glucose (mg/dL)</measure>
    <time_frame>baseline, 7 days, 14 days, and 30 days post supplementation.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in glucose regulation assessed via insulin (mIU/L)</measure>
    <time_frame>baseline, 7 days, 14 days, and 30 days post supplementation.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in glucose regulation assessed via glycated albumin (%).</measure>
    <time_frame>baseline, 7 days, 14 days, and 30 days post supplementation.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in sleep quantity (hours and minutes) assessed via daily survey.</measure>
    <time_frame>daily for 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in sleep quality measured via 100mm visual analogue scale.</measure>
    <time_frame>daily for 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in gut microbiome bacterial counts</measure>
    <time_frame>baseline, 14 days, and 30 days post supplementation.</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Inflammation</condition>
  <condition>Glucose Regulation</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Tart cherry juice concentrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tart cherry juice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Freeze dried tart cherry powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tart cherry capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Juice placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>kool-aid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Capsule placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>maltodextrin</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tart cherry juice concentrate</intervention_name>
    <description>Two 8oz bottles of tart cherry juice concentrate daily for 30 days</description>
    <arm_group_label>Tart cherry juice concentrate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Juice placebo</intervention_name>
    <description>Two 8oz bottles of placebo juice daily for 30 days</description>
    <arm_group_label>Juice placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Freeze dried tart cherry powder</intervention_name>
    <description>Two freeze dried tart cherry powder capsules daily for 30 days</description>
    <arm_group_label>Freeze dried tart cherry powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Capsule placebo</intervention_name>
    <description>Two placebo capsules daily for 30 days</description>
    <arm_group_label>Capsule placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-55 years old&#xD;
&#xD;
          -  participate in 150 minutes of exercise per week&#xD;
&#xD;
          -  non-smoker&#xD;
&#xD;
          -  have no known allergy to cherries or cherry juice&#xD;
&#xD;
          -  are not taking food supplements (turmeric/curcumin, cherry products, greens, etc.).&#xD;
             -You must have access to the internet and be willing to record your food intake,&#xD;
             physical activity and sleep quality/duration during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not 18-55 years old.&#xD;
&#xD;
          -  have quit smoking less than one year ago.&#xD;
&#xD;
          -  have been diagnosed with a metabolic disorder such as diabetes, thyroid disorder, or&#xD;
             high cholesterol.&#xD;
&#xD;
          -  are currently being treated for arthritis or an inflammatory condition, such as&#xD;
             arthritis, gout, lupus or Sjogren's syndrome.&#xD;
&#xD;
          -  are currently being treated for cardiovascular disease, high blood pressure,&#xD;
             fibromyalgia, or irritable bowel syndrome.&#xD;
&#xD;
          -  are pregnant.&#xD;
&#xD;
          -  regularly consume cherries or are allergic to cherries.&#xD;
&#xD;
          -  currently use anti-inflammatory medications.&#xD;
&#xD;
          -  have used corticosteroids in the last two months.&#xD;
&#xD;
          -  are not willing to follow a low polyphenol diet.&#xD;
&#xD;
          -  are not willing to have blood drawn on 4 occasions.&#xD;
&#xD;
          -  are not willing to provide a stool sample on 3 occasions.&#xD;
&#xD;
          -  do not have access to the internet.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ohio University Exercise Physiology Lab</name>
      <address>
        <city>Athens</city>
        <state>Ohio</state>
        <zip>45701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</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>Available by 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/NCT04467372
org study id: 18-F-13
nct id: NCT04467372
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There has been a rapid increase in researching the use of tart cherry supplements in the past
      5 years, particularly for inflammatory conditions. Many formulations of cherry supplements
      exist, however there has been no comparison between these different types. This is
      particularly important in the realm of inflammation research because sugar is known to
      increase the inflammatory response. The pill form of cherry supplementation has no added
      sugar and is naturally low in sugar (< 1g) while the juice form is higher from added sugar.
      Recent work indicates tart cherry consumption can change gut microbiota, which may modify
      inflammation. The purpose of this study is to look at the effects of taking a cherry
      supplement, either in capsule or juice form, on the gut microbiome, inflammation, and
      health-related variables such as blood pressure, glucose regulation and sleep quality.
Participants will consume a tart cherry or placebo product for 30 days and attend 5 visits in
      the Exercise Physiology Lab at Ohio University over the 30 day period. They will self-collect
      a stool sample at baseline, 14 days and 30 days after supplementation. Blood samples will be
      taken at baseline, 7 days, 14 days, and 30 days after supplementation. Throughout the study
      participates will rate symptoms (stomach, head, etc.), pain and sleep quality using an online
      survey for which the link will be emailed. Participants will maintain normal diet and
      exercise routine and to track these for the duration of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Changes in inflammation measured via tumor necrosis factor alpha (pg/mL)
time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
measure: Changes in inflammation measured via erythrocyte sedimentation rate (mm/hour)
time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
measure: Changes in inflammation measured via c-reactive protein (mg/L) and uric acid (mg/dL).
time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
measure: Changes in glucose regulation assessed via plasma glucose (mg/dL)
time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
measure: Changes in glucose regulation assessed via insulin (mIU/L)
time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
measure: Changes in glucose regulation assessed via glycated albumin (%).
time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
measure: Changes in sleep quantity (hours and minutes) assessed via daily survey.
time frame: daily for 30 days
measure: Changes in sleep quality measured via 100mm visual analogue scale.
time frame: daily for 30 days
measure: Changes in gut microbiome bacterial counts
time frame: baseline, 14 days, and 30 days post supplementation.
arm group label: Tart cherry juice concentrate
arm group type: Experimental
description: tart cherry juice
arm group label: Freeze dried tart cherry powder
arm group type: Experimental
description: tart cherry capsules
arm group label: Juice placebo
arm group type: Experimental
description: kool-aid
arm group label: Capsule placebo
arm group type: Experimental
description: maltodextrin
intervention type: Dietary Supplement
intervention name: Tart cherry juice concentrate
description: Two 8oz bottles of tart cherry juice concentrate daily for 30 days
arm group label: Tart cherry juice concentrate
intervention type: Dietary Supplement
intervention name: Juice placebo
description: Two 8oz bottles of placebo juice daily for 30 days
arm group label: Juice placebo
intervention type: Dietary Supplement
intervention name: Freeze dried tart cherry powder
description: Two freeze dried tart cherry powder capsules daily for 30 days
arm group label: Freeze dried tart cherry powder
intervention type: Dietary Supplement
intervention name: Capsule placebo
description: Two placebo capsules daily for 30 days
arm group label: Capsule placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
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: Available by request