<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/NCT03783013</url>
  </required_header>
  <id_info>
    <org_study_id>HS61 - Tomato Juice Study</org_study_id>
    <nct_id>NCT03783013</nct_id>
  </id_info>
  <brief_title>Tomato Juice for Health Study</brief_title>
  <official_title>The Influence of Tomato Soy Juice on Inflammation in Overweight and Obese Adults</official_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine if tomato-soy juice can reduce&#xD;
      inflammation, which is linked to chronic disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to improve understanding of how diet can ameliorate the state of&#xD;
      chronic inflammation. Short term inflammation is an important part of the body's response to&#xD;
      injury, but long term inflammation, as happens in the state of obesity, can result in a&#xD;
      multitude of secondary problems, like cancer, diabetes, and cardiovascular disease. Using a&#xD;
      novel tomato-soy juice, we aim to demonstrate the potential of tomato-soy juice for reducing&#xD;
      inflammation in adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    This study was halted prematurely because of research restrictions related to COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">August 25, 2021</completion_date>
  <primary_completion_date type="Actual">August 25, 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>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interleukin 6</measure>
    <time_frame>Day 15 of the study</time_frame>
    <description>Interleukin 6 (IL6) is a blood cytokine and an indicator of inflammatory status. IL6 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin 6</measure>
    <time_frame>Day 43 of the study</time_frame>
    <description>Interleukin 6 (IL6) is a blood cytokine and an indicator of inflammatory status. IL6 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin 6</measure>
    <time_frame>Day 71 of the study</time_frame>
    <description>Interleukin 6 (IL6) is a blood cytokine and an indicator of inflammatory status. IL6 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin 6</measure>
    <time_frame>Day 99 of the study</time_frame>
    <description>Interleukin 6 (IL6) is a blood cytokine and an indicator of inflammatory status. IL6 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin 8</measure>
    <time_frame>Day 15 of the study</time_frame>
    <description>Interleukin 8 (IL8) is a blood cytokine and an indicator of inflammatory status. IL8 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin 8</measure>
    <time_frame>Day 43 of the study</time_frame>
    <description>Interleukin 8 (IL8) is a blood cytokine and an indicator of inflammatory status. IL8 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin 8</measure>
    <time_frame>Day 71 of the study</time_frame>
    <description>Interleukin 8 (IL8) is a blood cytokine and an indicator of inflammatory status. IL8 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin 8</measure>
    <time_frame>Day 99 of the study</time_frame>
    <description>Interleukin 8 (IL8) is a blood cytokine and an indicator of inflammatory status. IL8 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor Necrosis Factor Alpha</measure>
    <time_frame>Day 15 of the study</time_frame>
    <description>Tumor Necrosis Factor Alpha (TNF-a) is a blood cytokine and an indicator of inflammatory status. TNF-a will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor Necrosis Factor Alpha</measure>
    <time_frame>Day 43 of the study</time_frame>
    <description>Tumor Necrosis Factor Alpha (TNF-a) is a blood cytokine and an indicator of inflammatory status. TNF-a will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor Necrosis Factor Alpha</measure>
    <time_frame>Day 71 of the study</time_frame>
    <description>Tumor Necrosis Factor Alpha (TNF-a) is a blood cytokine and an indicator of inflammatory status. TNF-a will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor Necrosis Factor Alpha</measure>
    <time_frame>Day 99 of the study</time_frame>
    <description>Tumor Necrosis Factor Alpha (TNF-a) is a blood cytokine and an indicator of inflammatory status. TNF-a will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocyte chemoattractant protein-1</measure>
    <time_frame>Day 15 of the study</time_frame>
    <description>Monocyte chemoattractant protein-1 (MCP-1) is a signalling molecule and is part of the inflammatory process. MCP-1 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocyte chemoattractant protein-1</measure>
    <time_frame>Day 43 of the study</time_frame>
    <description>Monocyte chemoattractant protein-1 (MCP-1) is a signalling molecule and is part of the inflammatory process. MCP-1 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocyte chemoattractant protein-1</measure>
    <time_frame>Day 71 of the study</time_frame>
    <description>Monocyte chemoattractant protein-1 (MCP-1) is a signalling molecule and is part of the inflammatory process. MCP-1 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocyte chemoattractant protein-1</measure>
    <time_frame>Day 99 of the study</time_frame>
    <description>Monocyte chemoattractant protein-1 (MCP-1) is a signalling molecule and is part of the inflammatory process. MCP-1 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interferon Gamma</measure>
    <time_frame>Day 15 of the study</time_frame>
    <description>Interferon gamma (INF-g) is a signalling molecule and is part of the inflammatory process. INF-g will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interferon Gamma</measure>
    <time_frame>Day 43 of the study</time_frame>
    <description>Interferon gamma (INF-g) is a signalling molecule and is part of the inflammatory process. INF-g will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interferon Gamma</measure>
    <time_frame>Day 71 of the study</time_frame>
    <description>Interferon gamma (INF-g) is a signalling molecule and is part of the inflammatory process. INF-g will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interferon Gamma</measure>
    <time_frame>Day 99 of the study</time_frame>
    <description>Interferon gamma (INF-g) is a signalling molecule and is part of the inflammatory process. INF-g will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Flavonoids/Isoflavones will be measured</measure>
    <time_frame>Days 1, 15, 43, 71, 99 of the study</time_frame>
    <description>Blood and Urine will be analyzed for flavonoids/isoflavones and their metabolites in units of nanomolar</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carotenoids will be measured</measure>
    <time_frame>Days 1, 15, 43, 71, 99 of the study</time_frame>
    <description>Blood will be analyzed for carotenoids and metabolites in units of mmolar</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of metabolites that change in blood and urine by metabolomics</measure>
    <time_frame>Days 1, 15, 43, 71, 99 of the study</time_frame>
    <description>Metabolomics is the simultaneous measurement of the many thousand small molecule metabolites. Chromatography separates the metabolites, which are then ionized, then the detector detects the number of ion hits for each ion, which reflects the amount (number of ions) of a particular compound. If the detector detects more of an ion in blood or urine after one treatment vs. another, then the position on the chromatogram (units of time in minutes) and the ratio of the mass (atomic mass units) to charge (unitless) of the compound will be compared to the 75,000 entries in the METLIN metabolite library to identify what the compound is.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine production by peripheral blood mononuclear cells</measure>
    <time_frame>Day 1, 15, 43, 71, 99 of the study</time_frame>
    <description>Peripheral blood mononuclear cells produce inflammation molecules called cytokines when exposed to an irritant (called the stimulant in the assay). Peripheral blood mononuclear cells will be stimulated with an irritant and cytokine production will be measured in units of pg/ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood total cholesterol</measure>
    <time_frame>Day 1, 15, 43, 71, 99 of the study</time_frame>
    <description>Total cholesterol will be measured in blood. Units will be mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood LDL cholesterol</measure>
    <time_frame>Day 1, 15, 43, 71, 99 of the study</time_frame>
    <description>LDL cholesterol will be measured in blood. Units will be mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood HDL cholesterol</measure>
    <time_frame>Day 1, 15, 43, 71, 99 of the study</time_frame>
    <description>HDL cholesterol will be measured in blood. Units will be mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood triglycerides</measure>
    <time_frame>Day 1, 15, 43, 71, 99 of the study</time_frame>
    <description>Triglycerides will be measured in blood. Units will be mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>Day 1, 15, 43, 71, 99 of the study</time_frame>
    <description>Glucose will be measured in blood. Units will be mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood insulin</measure>
    <time_frame>Day 1, 15, 43, 71, 99 of the study</time_frame>
    <description>Insulin will be measured in blood. Units will be mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Day 1, 15, 43, 71, 99 of the study</time_frame>
    <description>Blood pressure will be measured. Units will be mm Hg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High Sensitivity c-Reactive Protein</measure>
    <time_frame>Day 1, 15, 43, 71, 99 of the study</time_frame>
    <description>High sensitivity c-reactive protein will be measured in blood. Units will be mg/dL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>No Soy and Low Lycopene Juice</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will consume two cans daily of a low lycopene tomato juice in addition to a diet low in lycopene and isoflavones.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Soy and Lycopene Juice</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will consume two cans daily of a high lycopene tomato juice with added soy germ extract in addition to a diet low in lycopene and isoflavones.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Lycopene Tomato Juice With Soy Germ Extract</intervention_name>
    <description>Tomato juice made from high lycopene tomatoes with soy germ extract added</description>
    <arm_group_label>Soy and Lycopene Juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low Lycopene Tomato Juice</intervention_name>
    <description>Tomato juice made from low lycopene tomatoes with no soy germ extract added</description>
    <arm_group_label>No Soy and Low Lycopene Juice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 30 and 75 years old&#xD;
&#xD;
          -  Voluntarily agree to participate and sign an informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged &lt; 30 years or &gt; 75 years&#xD;
&#xD;
          -  Known allergy or intolerance to tomatoes or soy&#xD;
&#xD;
          -  BMI &lt; 30 or &gt; 45 kg/m2&#xD;
&#xD;
          -  Blood plasma glucose &gt; 125 mg/dL&#xD;
&#xD;
          -  Blood plasma/serum triglycerides &gt; 250 mg/dL&#xD;
&#xD;
          -  Blood plasma/serum cholesterol &gt; 240 mg/dL&#xD;
&#xD;
          -  Diabetes requiring the use of diabetes pills, insulin, or non-insulin shots&#xD;
&#xD;
          -  Previous bariatric or gastrointestinal surgery affecting absorption&#xD;
&#xD;
          -  Suspected or known strictures, fistulas or physiological/mechanical gastrointestinal&#xD;
             obstruction&#xD;
&#xD;
          -  Presence of gastrointestinal or malabsorptive disorders (including Crohn's, ileus or&#xD;
             ulcerative colitis, or diverticulitis), or nutrient malabsorption disease (such as&#xD;
             celiac disease)&#xD;
&#xD;
          -  Presence of autoimmune disease, metabolic disease, liver disorders, or kidney&#xD;
             disorders&#xD;
&#xD;
          -  Diagnosis or treatment of certain cancers in the past 3 years&#xD;
&#xD;
          -  Use of tobacco products or marijuana&#xD;
&#xD;
          -  Daily use of anti-inflammatory drugs&#xD;
&#xD;
          -  Use of antibiotics over the previous 3 months&#xD;
&#xD;
          -  Colonoscopy within a month of the study start date or during the study&#xD;
&#xD;
          -  Use of a carotenoid or isoflavone-containing or metabolism-altering supplement for the&#xD;
             last 1 month&#xD;
&#xD;
          -  Use of certain medications (prescription or over-the-counter) that may interfere with&#xD;
             the study objectives&#xD;
&#xD;
          -  Unable or unwilling to give informed consent or communicate with study staff&#xD;
&#xD;
          -  Other medical, psychiatric, or behavioral factors that in the judgment of the&#xD;
             Principal Investigator may interfere with study participation or the ability to follow&#xD;
             the intervention protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>USDA-ARS Beltsville Human Nutrition Research 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>June 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>June 7, 2022</last_update_submitted>
  <last_update_submitted_qc>June 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2022</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lycopene</mesh_term>
  </intervention_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/NCT03783013
org study id: HS61 - Tomato Juice Study
nct id: NCT03783013
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to determine if tomato-soy juice can reduce
      inflammation, which is linked to chronic disease
The aim of this study is to improve understanding of how diet can ameliorate the state of
      chronic inflammation. Short term inflammation is an important part of the body's response to
      injury, but long term inflammation, as happens in the state of obesity, can result in a
      multitude of secondary problems, like cancer, diabetes, and cardiovascular disease. Using a
      novel tomato-soy juice, we aim to demonstrate the potential of tomato-soy juice for reducing
      inflammation in adults.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Interleukin 6
time frame: Day 15 of the study
description: Interleukin 6 (IL6) is a blood cytokine and an indicator of inflammatory status. IL6 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interleukin 6
time frame: Day 43 of the study
description: Interleukin 6 (IL6) is a blood cytokine and an indicator of inflammatory status. IL6 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interleukin 6
time frame: Day 71 of the study
description: Interleukin 6 (IL6) is a blood cytokine and an indicator of inflammatory status. IL6 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interleukin 6
time frame: Day 99 of the study
description: Interleukin 6 (IL6) is a blood cytokine and an indicator of inflammatory status. IL6 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interleukin 8
time frame: Day 15 of the study
description: Interleukin 8 (IL8) is a blood cytokine and an indicator of inflammatory status. IL8 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interleukin 8
time frame: Day 43 of the study
description: Interleukin 8 (IL8) is a blood cytokine and an indicator of inflammatory status. IL8 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interleukin 8
time frame: Day 71 of the study
description: Interleukin 8 (IL8) is a blood cytokine and an indicator of inflammatory status. IL8 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interleukin 8
time frame: Day 99 of the study
description: Interleukin 8 (IL8) is a blood cytokine and an indicator of inflammatory status. IL8 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Tumor Necrosis Factor Alpha
time frame: Day 15 of the study
description: Tumor Necrosis Factor Alpha (TNF-a) is a blood cytokine and an indicator of inflammatory status. TNF-a will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Tumor Necrosis Factor Alpha
time frame: Day 43 of the study
description: Tumor Necrosis Factor Alpha (TNF-a) is a blood cytokine and an indicator of inflammatory status. TNF-a will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Tumor Necrosis Factor Alpha
time frame: Day 71 of the study
description: Tumor Necrosis Factor Alpha (TNF-a) is a blood cytokine and an indicator of inflammatory status. TNF-a will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Tumor Necrosis Factor Alpha
time frame: Day 99 of the study
description: Tumor Necrosis Factor Alpha (TNF-a) is a blood cytokine and an indicator of inflammatory status. TNF-a will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Monocyte chemoattractant protein-1
time frame: Day 15 of the study
description: Monocyte chemoattractant protein-1 (MCP-1) is a signalling molecule and is part of the inflammatory process. MCP-1 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Monocyte chemoattractant protein-1
time frame: Day 43 of the study
description: Monocyte chemoattractant protein-1 (MCP-1) is a signalling molecule and is part of the inflammatory process. MCP-1 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Monocyte chemoattractant protein-1
time frame: Day 71 of the study
description: Monocyte chemoattractant protein-1 (MCP-1) is a signalling molecule and is part of the inflammatory process. MCP-1 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Monocyte chemoattractant protein-1
time frame: Day 99 of the study
description: Monocyte chemoattractant protein-1 (MCP-1) is a signalling molecule and is part of the inflammatory process. MCP-1 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interferon Gamma
time frame: Day 15 of the study
description: Interferon gamma (INF-g) is a signalling molecule and is part of the inflammatory process. INF-g will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interferon Gamma
time frame: Day 43 of the study
description: Interferon gamma (INF-g) is a signalling molecule and is part of the inflammatory process. INF-g will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interferon Gamma
time frame: Day 71 of the study
description: Interferon gamma (INF-g) is a signalling molecule and is part of the inflammatory process. INF-g will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Interferon Gamma
time frame: Day 99 of the study
description: Interferon gamma (INF-g) is a signalling molecule and is part of the inflammatory process. INF-g will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
measure: Flavonoids/Isoflavones will be measured
time frame: Days 1, 15, 43, 71, 99 of the study
description: Blood and Urine will be analyzed for flavonoids/isoflavones and their metabolites in units of nanomolar
measure: Carotenoids will be measured
time frame: Days 1, 15, 43, 71, 99 of the study
description: Blood will be analyzed for carotenoids and metabolites in units of mmolar
measure: Identification of metabolites that change in blood and urine by metabolomics
time frame: Days 1, 15, 43, 71, 99 of the study
description: Metabolomics is the simultaneous measurement of the many thousand small molecule metabolites. Chromatography separates the metabolites, which are then ionized, then the detector detects the number of ion hits for each ion, which reflects the amount (number of ions) of a particular compound. If the detector detects more of an ion in blood or urine after one treatment vs. another, then the position on the chromatogram (units of time in minutes) and the ratio of the mass (atomic mass units) to charge (unitless) of the compound will be compared to the 75,000 entries in the METLIN metabolite library to identify what the compound is.
measure: Cytokine production by peripheral blood mononuclear cells
time frame: Day 1, 15, 43, 71, 99 of the study
description: Peripheral blood mononuclear cells produce inflammation molecules called cytokines when exposed to an irritant (called the stimulant in the assay). Peripheral blood mononuclear cells will be stimulated with an irritant and cytokine production will be measured in units of pg/ml.
measure: Blood total cholesterol
time frame: Day 1, 15, 43, 71, 99 of the study
description: Total cholesterol will be measured in blood. Units will be mmol/L.
measure: Blood LDL cholesterol
time frame: Day 1, 15, 43, 71, 99 of the study
description: LDL cholesterol will be measured in blood. Units will be mmol/L.
measure: Blood HDL cholesterol
time frame: Day 1, 15, 43, 71, 99 of the study
description: HDL cholesterol will be measured in blood. Units will be mmol/L.
measure: Blood triglycerides
time frame: Day 1, 15, 43, 71, 99 of the study
description: Triglycerides will be measured in blood. Units will be mmol/L.
measure: Blood glucose
time frame: Day 1, 15, 43, 71, 99 of the study
description: Glucose will be measured in blood. Units will be mmol/L.
measure: Blood insulin
time frame: Day 1, 15, 43, 71, 99 of the study
description: Insulin will be measured in blood. Units will be mmol/L.
measure: Blood pressure
time frame: Day 1, 15, 43, 71, 99 of the study
description: Blood pressure will be measured. Units will be mm Hg.
measure: High Sensitivity c-Reactive Protein
time frame: Day 1, 15, 43, 71, 99 of the study
description: High sensitivity c-reactive protein will be measured in blood. Units will be mg/dL.
arm group label: No Soy and Low Lycopene Juice
arm group type: Other
description: Participants will consume two cans daily of a low lycopene tomato juice in addition to a diet low in lycopene and isoflavones.
arm group label: Soy and Lycopene Juice
arm group type: Other
description: Participants will consume two cans daily of a high lycopene tomato juice with added soy germ extract in addition to a diet low in lycopene and isoflavones.
intervention type: Other
intervention name: High Lycopene Tomato Juice With Soy Germ Extract
description: Tomato juice made from high lycopene tomatoes with soy germ extract added
arm group label: Soy and Lycopene Juice
intervention type: Other
intervention name: Low Lycopene Tomato Juice
description: Tomato juice made from low lycopene tomatoes with no soy germ extract added
arm group label: No Soy and Low Lycopene Juice
criteria: 
gender: All
minimum age: 30 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
mesh term: Lycopene
sharing ipd: No