<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/NCT03283969</url>
  </required_header>
  <id_info>
    <org_study_id>956223</org_study_id>
    <nct_id>NCT03283969</nct_id>
  </id_info>
  <brief_title>Influence of Freeze Dried Strawberry Consumption on Gut Microbiota and Cardiovascular Health.</brief_title>
  <official_title>Probe Study Investigation on the Influence of Freeze Dried Strawberry Consumption on Gut Microbiota, Intestinal Health, Metabolic Phenotype and Cardiovascular Risk in Overweight and Obese Individuals.</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposal seeks to build upon studies, including ours, on the favorable effects of&#xD;
      California strawberries on vascular health. Freeze dried strawberry powder (FDSP) contains a&#xD;
      number of nutrients that may have beneficial effects on plasma lipids and vascular function,&#xD;
      as well as on the composition of the gut microbiota; changes in the gut microbiota can in&#xD;
      turn have secondary positive effects on the vascular system as well as on other physiological&#xD;
      functions that are important determinants of health and disease. The proposed project will&#xD;
      seek to determine the influence of short-term FDSP intake on the gut microbiota composition,&#xD;
      and select microbial-derived metabolites from stool, serum and urine, and their relationship&#xD;
      to microvascular function. Secondary outcomes will include the influence of the FDSP on&#xD;
      circulating levels of nitrate and nitrite and trimethylamine oxide (TMAO) as markers of&#xD;
      vascular health that are influenced by both dietary intake and the oral and gut microflora,&#xD;
      with blood pressure as an additional vascular outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double-blind, controlled crossover design will compare the short-term (two and&#xD;
      four week) response to FDSP intake compared to an isocaloric control powder in overweight and&#xD;
      obese adults. Twenty overweight or obese male or postmenopausal females (40-65 years of age)&#xD;
      will be randomized to consume 39 g of FDSP or a control powder for four weeks in a crossover&#xD;
      design with a four week washout period. Changes in stool microbial communities and microbial&#xD;
      metabolites will be assessed, and examined for their potential influence on microvascular&#xD;
      function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized, double-blind, controlled crossover dietary intervention trial</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The test powders where pre-packaged by the study sponsor and sent to the investigators coded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Peripheral Arterial Tonometry (PAT)</measure>
    <time_frame>10 weeks</time_frame>
    <description>microvascular function testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gut Microbiome</measure>
    <time_frame>10 weeks</time_frame>
    <description>assessment of gut microbial populations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Untargeted Metabolomics</measure>
    <time_frame>10 weeks</time_frame>
    <description>assessment of primary metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Cholesterol</measure>
    <time_frame>10 weeks</time_frame>
    <description>plasma cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma LDL</measure>
    <time_frame>10 weeks</time_frame>
    <description>LDL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma HDL</measure>
    <time_frame>10 weeks</time_frame>
    <description>HDL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nitrate</measure>
    <time_frame>10 weeks</time_frame>
    <description>Circulating levels of Nitrate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nitrite</measure>
    <time_frame>10 weeks</time_frame>
    <description>Circulating levels of Nitrite</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Microbial Colonization</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control Powder</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Isocaloric powder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Freeze Dried Strawberry Powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Contains freeze dried strawberries</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Freeze Dried Strawberry Powder</intervention_name>
    <description>Study participants will be randomized to receive either the freeze dried strawberry powder or the control powder first. They will be instructed to consume 39g of the powder, mixed in water, every day for 4 weeks.</description>
    <arm_group_label>Control Powder</arm_group_label>
    <arm_group_label>Freeze Dried Strawberry Powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isocaloric powder</intervention_name>
    <description>Isocaloric powder</description>
    <arm_group_label>Control Powder</arm_group_label>
    <arm_group_label>Freeze Dried Strawberry Powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or postmenopausal female: 40-65 years&#xD;
&#xD;
          -  Women: lack of menses for at least two years.&#xD;
&#xD;
          -  Subject is willing and able to comply with the study protocols.&#xD;
&#xD;
          -  Subject is willing to participate in all study procedures&#xD;
&#xD;
          -  BMI 25.0 - 35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI ≥ 35 kg/m2&#xD;
&#xD;
          -  Dislike or allergy for strawberries or strawberry products&#xD;
&#xD;
          -  Self-reported use of daily anticoagulation agents including aspirin, NSAIDs&#xD;
&#xD;
          -  Vegan, Vegetarians, food faddists or those consuming a non-traditional diet&#xD;
&#xD;
          -  Fruit consumption ≥ 2 cups/day&#xD;
&#xD;
          -  Regular consumption of strawberries (2-3 cups/week)&#xD;
&#xD;
          -  Vegetable consumption ≥ 3 cups/day for females&#xD;
&#xD;
          -  Fatty Fish ≥ 3 times/week&#xD;
&#xD;
          -  Coffee/tea ≥ 3 cups/day&#xD;
&#xD;
          -  Dark chocolate ≥ 3 oz/day&#xD;
&#xD;
          -  Self-reported restriction of physical activity due to a chronic health condition&#xD;
&#xD;
          -  Self-reported chronic/routine high intensity exercise&#xD;
&#xD;
          -  Self-reported diabetes&#xD;
&#xD;
          -  Blood pressure ≥ 140/90 mm Hg&#xD;
&#xD;
          -  Self-reported renal or liver disease&#xD;
&#xD;
          -  Self-reported heart disease, which includes cardiovascular events and stroke&#xD;
&#xD;
          -  Inability to properly place or wear the PAT probes or abnormal measurements on pre-&#xD;
             screening PAT&#xD;
&#xD;
          -  Abnormal Metabolic or CBC panels (laboratory values outside the reference range) if&#xD;
             determined to be clinically significant by the study physician.&#xD;
&#xD;
          -  Self-reported cancer within past 5 years&#xD;
&#xD;
          -  Self-reported malabsorption&#xD;
&#xD;
          -  Currently taking prescription drugs or supplements.&#xD;
&#xD;
          -  Use of multi-vitamin and mineral other than a general formula of vitamins and minerals&#xD;
             that meet the RDA&#xD;
&#xD;
          -  Not willing to stop any supplement use, including herbal, plant or botanical, fish&#xD;
             oil, oil supplements a month prior to study enrollment.&#xD;
&#xD;
          -  Indications of substance or alcohol abuse within the last 3 years&#xD;
&#xD;
          -  Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL&#xD;
             cholesterol (i.e. family history of premature coronary artery disease (male first&#xD;
             degree relative &lt; 55 years; CHD in female first degree relative &lt; 65 years), cigarette&#xD;
             smoker, HDL-C ≤ 40 mg/dL].&#xD;
&#xD;
          -  Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL&#xD;
             cholesterol [i.e. family history of premature coronary artery disease (male first&#xD;
             degree relative &lt; 55 years; CHD in female first degree relative &lt; 65 years), cigarette&#xD;
             smoker, HDL-C ≤ 40 mg/dL]. (using NCEP calculator&#xD;
             http://cvdrisk.nhlbi.nih.gov/calculator.asp);&#xD;
&#xD;
          -  Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL&#xD;
             cholesterol [i.e. family history of premature coronary artery disease (male first&#xD;
             degree relative &lt; 55 years; CHD in female first degree relative &lt; 65 years), cigarette&#xD;
             smoker, HDL-C ≤ 40 mg/dL], and a Framingham 10-year Risk Score 10-20% (using NCEP&#xD;
             calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp).&#xD;
&#xD;
          -  Current enrollee in a clinical research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carl L Keen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Davis; Department of Nutrition</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>June 2022</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>June 2, 2022</last_update_submitted>
  <last_update_submitted_qc>June 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03283969
org study id: 956223
nct id: NCT03283969
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This proposal seeks to build upon studies, including ours, on the favorable effects of
      California strawberries on vascular health. Freeze dried strawberry powder (FDSP) contains a
      number of nutrients that may have beneficial effects on plasma lipids and vascular function,
      as well as on the composition of the gut microbiota; changes in the gut microbiota can in
      turn have secondary positive effects on the vascular system as well as on other physiological
      functions that are important determinants of health and disease. The proposed project will
      seek to determine the influence of short-term FDSP intake on the gut microbiota composition,
      and select microbial-derived metabolites from stool, serum and urine, and their relationship
      to microvascular function. Secondary outcomes will include the influence of the FDSP on
      circulating levels of nitrate and nitrite and trimethylamine oxide (TMAO) as markers of
      vascular health that are influenced by both dietary intake and the oral and gut microflora,
      with blood pressure as an additional vascular outcome.
A randomized, double-blind, controlled crossover design will compare the short-term (two and
      four week) response to FDSP intake compared to an isocaloric control powder in overweight and
      obese adults. Twenty overweight or obese male or postmenopausal females (40-65 years of age)
      will be randomized to consume 39 g of FDSP or a control powder for four weeks in a crossover
      design with a four week washout period. Changes in stool microbial communities and microbial
      metabolites will be assessed, and examined for their potential influence on microvascular
      function.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized, double-blind, controlled crossover dietary intervention trial
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
masking description: The test powders where pre-packaged by the study sponsor and sent to the investigators coded.
measure: Peripheral Arterial Tonometry (PAT)
time frame: 10 weeks
description: microvascular function testing
measure: Gut Microbiome
time frame: 10 weeks
description: assessment of gut microbial populations
measure: Untargeted Metabolomics
time frame: 10 weeks
description: assessment of primary metabolites
measure: Plasma Cholesterol
time frame: 10 weeks
description: plasma cholesterol
measure: Plasma LDL
time frame: 10 weeks
description: LDL
measure: Plasma HDL
time frame: 10 weeks
description: HDL
measure: Nitrate
time frame: 10 weeks
description: Circulating levels of Nitrate
measure: Nitrite
time frame: 10 weeks
description: Circulating levels of Nitrite
arm group label: Control Powder
arm group type: Placebo Comparator
description: Isocaloric powder
arm group label: Freeze Dried Strawberry Powder
arm group type: Experimental
description: Contains freeze dried strawberries
intervention type: Other
intervention name: Freeze Dried Strawberry Powder
description: Study participants will be randomized to receive either the freeze dried strawberry powder or the control powder first. They will be instructed to consume 39g of the powder, mixed in water, every day for 4 weeks.
arm group label: Control Powder
arm group label: Freeze Dried Strawberry Powder
intervention type: Other
intervention name: Isocaloric powder
description: Isocaloric powder
arm group label: Control Powder
arm group label: Freeze Dried Strawberry Powder
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carl L Keen, PhD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Cardiovascular Diseases
sharing ipd: No