<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/NCT02197754</url>
  </required_header>
  <id_info>
    <org_study_id>HS46</org_study_id>
    <nct_id>NCT02197754</nct_id>
  </id_info>
  <brief_title>Adaptation in Polyphenol Bioavailability and Bioactivity During Long Term Exposure to Polyphenol-Rich Foods</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA Beltsville Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USDA Beltsville Human Nutrition Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are two primary objectives to be addressed in this study: to assess the differential&#xD;
      response in bioavailability and metabolic pathways between lean and obese individuals exposed&#xD;
      to acute, short term (14 day), and long-term (10-week) consumption of polyphenol-rich fruits&#xD;
      (berries and apple), and beverages (tea); and to determine the differential systemic and gut&#xD;
      anti-inflammatory response between obese and lean individuals exposed to polyphenol-rich&#xD;
      fruits (berries and apple), and beverages (tea).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Polyphenol metabolites - Wk 2</measure>
    <time_frame>2 weeks after start of intervention</time_frame>
    <description>Polyphenol metabolites will be measured in blood and urine after 2 weeks of a controlled diet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Polyphenol metabolites - Wk 4</measure>
    <time_frame>4 weeks after start of intervention</time_frame>
    <description>Polyphenol metabolites will be measured in blood and urine after 4 weeks of a controlled diet. Weeks 3 and 4 will contain fruits and beverage rich in polyphenols.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Polyphenol metabolites - Wk 10</measure>
    <time_frame>10 weeks after start of intervention</time_frame>
    <description>Polyphenol metabolites will be measured in blood and urine after 10 weeks of a controlled diet. Weeks 3 through 10 will contain fruits and beverage rich in polyphenols.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic inflammation - Wk 2</measure>
    <time_frame>2 weeks after start of intervention</time_frame>
    <description>Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic Inflammation - Wk 4</measure>
    <time_frame>4 weeks after start of intervention</time_frame>
    <description>Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic Inflammation - Wk 10</measure>
    <time_frame>10 weeks after start of intervention</time_frame>
    <description>Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Health - Wk 2</measure>
    <time_frame>2 weeks after start of intervention</time_frame>
    <description>Gut permeability and inflammation will be measured in fecal samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Health - Wk 4</measure>
    <time_frame>Wk 4</time_frame>
    <description>Gut permeability and inflammation will be measured in fecal samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Health - Wk 10</measure>
    <time_frame>10 weeks after start of intervention</time_frame>
    <description>Gut permeability and inflammation will be measured in fecal samples.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Polyphenol Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 2 weeks of adaptation to a controlled diet, polyphenol-rich fruits (berries and apple) and beverages (tea) will be fed (8 wks) as part of a controlled diet (10 wks total).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Controlled diet</intervention_name>
    <description>Volunteers will be provided a controlled diet during the entirety of the 10 week treatment period. Meals will be prepared using traditional American foods.&#xD;
The controlled diet will include polyphenol-rich foods, including apples, berries, and green tea. A blend of multiple polyphenol-rich foods was chosen to investigate whole foods, multiple commodities, and multiple bioactives.</description>
    <arm_group_label>Polyphenol Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 25 years old or older than 75 years old&#xD;
&#xD;
          -  Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol),&#xD;
             or Miradon (anisindione)&#xD;
&#xD;
          -  Presence of any gastrointestinal disease, metabolic disease, bariatric surgery, or&#xD;
             malabsorption syndromes that may interfere with the study goals&#xD;
&#xD;
          -  Have been pregnant during the previous 12 months, are currently pregnant or lactating,&#xD;
             or plan to become pregnant during the study&#xD;
&#xD;
          -  Type 2 diabetes requiring the use of oral antidiabetic agents or insulin&#xD;
&#xD;
          -  Fasting triglycerides greater than 300 mg/dL&#xD;
&#xD;
          -  Fasting glucose greater than 126 mg/dL&#xD;
&#xD;
          -  History of eating disorders or other dietary patterns which are not consistent with&#xD;
             the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)&#xD;
&#xD;
          -  Use of prescription or over-the-counter antiobesity medications or supplements (e.g.,&#xD;
             phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to&#xD;
             the start of the study or a history of a surgical intervention for obesity&#xD;
&#xD;
          -  Active cardiovascular disease (such as a heart attack or procedure within the past&#xD;
             three months or participation in a cardiac rehabilitation program within the last&#xD;
             three months, stroke, or history/treatment for transient ischemic attacks in the past&#xD;
             three months, or documented history of pulmonary embolus in the past six months).&#xD;
&#xD;
          -  Use of any tobacco products in past 3 months&#xD;
&#xD;
          -  Unwillingness to abstain from herbal supplements for two weeks prior to the study and&#xD;
             during the study&#xD;
&#xD;
          -  Known (self-reported) allergy or adverse reaction to study foods&#xD;
&#xD;
          -  Unable or unwilling to give informed consent or communicate with study staff&#xD;
&#xD;
          -  Self-report of alcohol or substance abuse within the past twelve months and/or current&#xD;
             acute treatment or rehabilitation program for these problems (Long-term participation&#xD;
             in Alcoholics Anonymous is not an exclusion)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beltsville Human Nutrition Center</name>
      <address>
        <city>Beltsville</city>
        <state>Maryland</state>
        <zip>20705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>January 15, 2015</last_update_submitted>
  <last_update_submitted_qc>January 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>USDA Beltsville Human Nutrition Research Center</investigator_affiliation>
    <investigator_full_name>Janet Novotny</investigator_full_name>
    <investigator_title>Research Physiologist</investigator_title>
  </responsible_party>
  <keyword>pharmacokinetics</keyword>
  <keyword>polyphenol metabolites</keyword>
  <keyword>lean individuals</keyword>
  <keyword>obese individuals</keyword>
  <!-- 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/NCT02197754
org study id: HS46
nct id: NCT02197754
lead sponsor: 
has dmc: No
There are two primary objectives to be addressed in this study: to assess the differential
      response in bioavailability and metabolic pathways between lean and obese individuals exposed
      to acute, short term (14 day), and long-term (10-week) consumption of polyphenol-rich fruits
      (berries and apple), and beverages (tea); and to determine the differential systemic and gut
      anti-inflammatory response between obese and lean individuals exposed to polyphenol-rich
      fruits (berries and apple), and beverages (tea).
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Polyphenol metabolites - Wk 2
time frame: 2 weeks after start of intervention
description: Polyphenol metabolites will be measured in blood and urine after 2 weeks of a controlled diet.
measure: Polyphenol metabolites - Wk 4
time frame: 4 weeks after start of intervention
description: Polyphenol metabolites will be measured in blood and urine after 4 weeks of a controlled diet. Weeks 3 and 4 will contain fruits and beverage rich in polyphenols.
measure: Polyphenol metabolites - Wk 10
time frame: 10 weeks after start of intervention
description: Polyphenol metabolites will be measured in blood and urine after 10 weeks of a controlled diet. Weeks 3 through 10 will contain fruits and beverage rich in polyphenols.
measure: Systemic inflammation - Wk 2
time frame: 2 weeks after start of intervention
description: Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.
measure: Systemic Inflammation - Wk 4
time frame: 4 weeks after start of intervention
description: Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.
measure: Systemic Inflammation - Wk 10
time frame: 10 weeks after start of intervention
description: Markers of inflammation (such as CRP, serum amyloid A, IL-6, IL-1B, TNF, and interferon-gamma will be measured.
measure: Gastrointestinal Health - Wk 2
time frame: 2 weeks after start of intervention
description: Gut permeability and inflammation will be measured in fecal samples.
measure: Gastrointestinal Health - Wk 4
time frame: Wk 4
description: Gut permeability and inflammation will be measured in fecal samples.
measure: Gastrointestinal Health - Wk 10
time frame: 10 weeks after start of intervention
description: Gut permeability and inflammation will be measured in fecal samples.
arm group label: Polyphenol Diet
arm group type: Experimental
description: After 2 weeks of adaptation to a controlled diet, polyphenol-rich fruits (berries and apple) and beverages (tea) will be fed (8 wks) as part of a controlled diet (10 wks total).
intervention type: Other
intervention name: Controlled diet
description: Volunteers will be provided a controlled diet during the entirety of the 10 week treatment period. Meals will be prepared using traditional American foods.
The controlled diet will include polyphenol-rich foods, including apples, berries, and green tea. A blend of multiple polyphenol-rich foods was chosen to investigate whole foods, multiple commodities, and multiple bioactives.
arm group label: Polyphenol Diet
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: USDA Beltsville Human Nutrition Research Center
investigator full name: Janet Novotny
investigator title: Research Physiologist