<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/NCT01705093</url>
  </required_header>
  <id_info>
    <org_study_id>333071</org_study_id>
    <nct_id>NCT01705093</nct_id>
  </id_info>
  <brief_title>The Effects of California Strawberries on Parameters of Cardiovascular Health</brief_title>
  <official_title>The Effects of California Strawberries on Parameters of Cardiovascular Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of childhood obesity has been increasing over the past couple of decades.&#xD;
      Similar to adults, overweight and obesity in young children and adolescents is associated&#xD;
      with an increased number of cardiovascular risk factors including dyslipidemia, hypertension,&#xD;
      insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that&#xD;
      foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea,&#xD;
      citrus fruits, and strawberries are protective against the development of cardiovascular&#xD;
      disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols,&#xD;
      flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have&#xD;
      observed that these isolated compounds, as well as strawberry extracts have the potential to&#xD;
      affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling&#xD;
      and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in&#xD;
      select measures of cardiovascular function in overweight and obese adolescent males.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vascular function measured by peripheral arterial tonometry</measure>
    <time_frame>Change from baseline in vascular function at 1 hour and 1 week</time_frame>
    <description>Change from baseline at 1 hour and 1 week post consumption of freeze-dried strawberry powder or control powder</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Flavonoid-rich freeze-dried strawberry powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50g of flavonoid-rich freeze-dried strawberry powder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>macronutrient- matched control powder</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>50g macronutrient-matched control powder that will lack strawberry flavonoids</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>flavonoid-rich freeze-dried strawberry powder</intervention_name>
    <description>50g of flavonoid-rich freeze-dried strawberry powder</description>
    <arm_group_label>Flavonoid-rich freeze-dried strawberry powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>macronutrient-matched control powder</intervention_name>
    <description>50g macronutrient-matched powder that will lack strawberry flavonoids</description>
    <arm_group_label>macronutrient- matched control powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subjects, age 14 - 18 years.&#xD;
&#xD;
          -  BMI for age and gender &gt;75th percentile (based on CDC growth charts)&#xD;
&#xD;
          -  Subject is willing and able to comply with the study protocols.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to wear PAT probes&#xD;
&#xD;
          -  Inability to remain still and remain quiet during test procedures&#xD;
&#xD;
          -  BMI for age and gender ≤ 75th percentile (based on CDC growth charts)&#xD;
&#xD;
          -  The use of medications that affect vascular function&#xD;
&#xD;
          -  Regular use of dietary supplements during the last 6 months&#xD;
&#xD;
          -  Blood pressure for age, gender and height ≥95th percentile&#xD;
&#xD;
          -  Chronic/routine high intensity exercise or current participation in a sports program&#xD;
&#xD;
          -  Self/Parent reported use of anticoagulation agents including NSAIDs&#xD;
&#xD;
          -  Self/Parent reported use of oral cortisone or other immunosuppressive agents,&#xD;
&#xD;
          -  Self/Parent reported underlying neoplasia or immunological disease&#xD;
&#xD;
          -  Self/Parent reported diabetes&#xD;
&#xD;
          -  Food faddists or those taking a non-traditional diet&#xD;
&#xD;
          -  Allergies to fruit&#xD;
&#xD;
          -  Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference&#xD;
&#xD;
          -  range) if determined to be clinically significant by the study physician.&#xD;
&#xD;
          -  Self/Parent reported malabsorption (e.g. difficulty digesting or absorbing nutrients&#xD;
             from food, potentially leading to bloating, cramping or gas).&#xD;
&#xD;
          -  Asthma (can be worsened by mild to moderate food allergies).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ragle Human Nutrition Research Center, Academic Surge, UC Davis</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>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>July 13, 2017</last_update_submitted>
  <last_update_submitted_qc>July 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>strawberry, cardiovascular, obesity, adolescent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Pediatric Obesity</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/NCT01705093
org study id: 333071
nct id: NCT01705093
lead sponsor: 
has dmc: No
The prevalence of childhood obesity has been increasing over the past couple of decades.
      Similar to adults, overweight and obesity in young children and adolescents is associated
      with an increased number of cardiovascular risk factors including dyslipidemia, hypertension,
      insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that
      foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea,
      citrus fruits, and strawberries are protective against the development of cardiovascular
      disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols,
      flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have
      observed that these isolated compounds, as well as strawberry extracts have the potential to
      affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling
      and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in
      select measures of cardiovascular function in overweight and obese adolescent males.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Vascular function measured by peripheral arterial tonometry
time frame: Change from baseline in vascular function at 1 hour and 1 week
description: Change from baseline at 1 hour and 1 week post consumption of freeze-dried strawberry powder or control powder
arm group label: Flavonoid-rich freeze-dried strawberry powder
arm group type: Experimental
description: 50g of flavonoid-rich freeze-dried strawberry powder
arm group label: macronutrient- matched control powder
arm group type: Placebo Comparator
description: 50g macronutrient-matched control powder that will lack strawberry flavonoids
intervention type: Dietary Supplement
intervention name: flavonoid-rich freeze-dried strawberry powder
description: 50g of flavonoid-rich freeze-dried strawberry powder
arm group label: Flavonoid-rich freeze-dried strawberry powder
intervention type: Dietary Supplement
intervention name: macronutrient-matched control powder
description: 50g macronutrient-matched powder that will lack strawberry flavonoids
arm group label: macronutrient- matched control powder
criteria: 
gender: Male
minimum age: 14 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Pediatric Obesity