<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/NCT02986165</url>
  </required_header>
  <id_info>
    <org_study_id>R15F10012</org_study_id>
    <nct_id>NCT02986165</nct_id>
  </id_info>
  <brief_title>Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation</brief_title>
  <acronym>Tomasa</acronym>
  <official_title>Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro de Estudios en Alimentos Procesados</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Talca</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quadram Institute Bioscience</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centro de Estudios en Alimentos Procesados</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the acute and longer term effects of a tomato pomace extract on platelet&#xD;
      aggregation in health subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evidence from human intervention trials and mechanistic studies suggests that tomato and&#xD;
      tomato based products are associated with a reduction in CVD risk. The mechanism by which&#xD;
      this protective effect occurs is not clearly understood but research has focused on its&#xD;
      potential to modulate platelet function. This single-blind, randomized, parallel design human&#xD;
      intervention trial will recruit 99 participants to consume an orange flavoured beverage&#xD;
      containing different doses of a tomato pomace extract (1.0 and 2.5 g) or placebo control over&#xD;
      a 5-day period. The study aims is to investigate the effects of consuming different doses of&#xD;
      the tomato pomace extract on platelet aggregation. Safety and tolerability of the tomato&#xD;
      pomace extracts was tested prior starting this study by undertaking a single ascending dose&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline platelet aggregation at three hours</measure>
    <time_frame>Blood samples on two separate occasions (baseline and three hours post-intervention)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline platelet aggregation at 5 days</measure>
    <time_frame>Blood samples on two separate occasions (baseline and 5 days post- intervention)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Placebo control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100 g of flavoured water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose pomace extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 g pomace extract powder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose pomace extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2.5 g pomace extract powder</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo control</intervention_name>
    <description>The placebo control is water containing a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions</description>
    <arm_group_label>Placebo control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low dose pomace extract</intervention_name>
    <description>Immediately prior to ingestion, 'drinks' containing 1 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.</description>
    <arm_group_label>Low dose pomace extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High dose pomace extract</intervention_name>
    <description>Immediately prior to ingestion, 'drinks' containing 2.5 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.</description>
    <arm_group_label>High dose pomace extract</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apparently healthy men aged between 18 and 26 years&#xD;
&#xD;
          -  BMI &gt;19.5 and &lt;26.0&#xD;
&#xD;
          -  Platelet aggregation response corresponding to ≥ 65%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known tomato allergy&#xD;
&#xD;
          -  Chronic medical conditions requiring active treatment (e.g. cardiovascular disease,&#xD;
             diabetes, asthma)&#xD;
&#xD;
          -  Gastro-intestinal disease/disorders&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Medically prescribed medication known to affect platelet function&#xD;
&#xD;
          -  Self-prescribed medication known to affect platelet function (e.g. aspirin and&#xD;
             non-steroidal anti-inflammatory drugs) unless participant is willing to give up.&#xD;
&#xD;
          -  Bleeding disorders (e.g. haemophilia)&#xD;
&#xD;
          -  Dietary supplements judged to affect study outcome&#xD;
&#xD;
          -  Parallel participation in another research project which involves dietary intervention&#xD;
&#xD;
          -  Blood donation within 16 weeks prior to the study&#xD;
&#xD;
          -  Depressed or elevated blood pressure measurements (&lt;90/50 or 95/50 if symptomatic or ≥&#xD;
             160/100 mmHg)&#xD;
&#xD;
          -  Any person related to or living with any member of the study team&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ivan Palomo, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Talca</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Talca</name>
      <address>
        <city>Talca</city>
        <state>Maule</state>
        <zip>3460000</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <reference>
    <citation>Law MR, Morris JK. By how much does fruit and vegetable consumption reduce the risk of ischaemic heart disease: response to commentary. Eur J Clin Nutr. 1999 Nov;53(11):903-4. doi: 10.1038/sj.ejcn.1600944.</citation>
    <PMID>10557006</PMID>
  </reference>
  <reference>
    <citation>Ruggeri ZM. Platelets in atherothrombosis. Nat Med. 2002 Nov;8(11):1227-34. doi: 10.1038/nm1102-1227. No abstract available.</citation>
    <PMID>12411949</PMID>
  </reference>
  <reference>
    <citation>Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007 Dec 13;357(24):2482-94. doi: 10.1056/NEJMra071014. No abstract available.</citation>
    <PMID>18077812</PMID>
  </reference>
  <reference>
    <citation>O'Kennedy N, Crosbie L, van Lieshout M, Broom JI, Webb DJ, Duttaroy AK. Effects of antiplatelet components of tomato extract on platelet function in vitro and ex vivo: a time-course cannulation study in healthy humans. Am J Clin Nutr. 2006 Sep;84(3):570-9. doi: 10.1093/ajcn/84.3.570.</citation>
    <PMID>16960171</PMID>
  </reference>
  <reference>
    <citation>Fuentes E, Forero-Doria O, Carrasco G, Marican A, Santos LS, Alarcon M, Palomo I. Effect of tomato industrial processing on phenolic profile and antiplatelet activity. Molecules. 2013 Sep 17;18(9):11526-36. doi: 10.3390/molecules180911526.</citation>
    <PMID>24048285</PMID>
  </reference>
  <reference>
    <citation>Fuentes E, Pereira J, Alarcon M, Valenzuela C, Perez P, Astudillo L, Palomo I. Protective Mechanisms of S. lycopersicum Aqueous Fraction (Nucleosides and Flavonoids) on Platelet Activation and Thrombus Formation: In Vitro, Ex Vivo and In Vivo Studies. Evid Based Complement Alternat Med. 2013;2013:609714. doi: 10.1155/2013/609714. Epub 2013 Sep 16.</citation>
    <PMID>24159349</PMID>
  </reference>
  <reference>
    <citation>Rodriguez-Azua R, Treuer A, Moore-Carrasco R, Cortacans D, Gutierrez M, Astudillo L, Fuentes E, Palomo I. Effect of tomato industrial processing (different hybrids, paste, and pomace) on inhibition of platelet function in vitro, ex vivo, and in vivo. J Med Food. 2014 Apr;17(4):505-11. doi: 10.1089/jmf.2012.0243. Epub 2013 Dec 10.</citation>
    <PMID>24325459</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>August 24, 2018</last_update_submitted>
  <last_update_submitted_qc>August 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Platelet Aggregation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 13, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT02986165/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02986165
org study id: R15F10012
nct id: NCT02986165
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study evaluates the acute and longer term effects of a tomato pomace extract on platelet
      aggregation in health subjects.
Evidence from human intervention trials and mechanistic studies suggests that tomato and
      tomato based products are associated with a reduction in CVD risk. The mechanism by which
      this protective effect occurs is not clearly understood but research has focused on its
      potential to modulate platelet function. This single-blind, randomized, parallel design human
      intervention trial will recruit 99 participants to consume an orange flavoured beverage
      containing different doses of a tomato pomace extract (1.0 and 2.5 g) or placebo control over
      a 5-day period. The study aims is to investigate the effects of consuming different doses of
      the tomato pomace extract on platelet aggregation. Safety and tolerability of the tomato
      pomace extracts was tested prior starting this study by undertaking a single ascending dose
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change from baseline platelet aggregation at three hours
time frame: Blood samples on two separate occasions (baseline and three hours post-intervention)
measure: Change from baseline platelet aggregation at 5 days
time frame: Blood samples on two separate occasions (baseline and 5 days post- intervention)
arm group label: Placebo control
arm group type: Placebo Comparator
description: 100 g of flavoured water
arm group label: Low dose pomace extract
arm group type: Experimental
description: 1 g pomace extract powder
arm group label: High dose pomace extract
arm group type: Experimental
description: 2.5 g pomace extract powder
intervention type: Dietary Supplement
intervention name: Placebo control
description: The placebo control is water containing a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions
arm group label: Placebo control
intervention type: Dietary Supplement
intervention name: Low dose pomace extract
description: Immediately prior to ingestion, 'drinks' containing 1 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.
arm group label: Low dose pomace extract
intervention type: Dietary Supplement
intervention name: High dose pomace extract
description: Immediately prior to ingestion, 'drinks' containing 2.5 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.
arm group label: High dose pomace extract
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ivan Palomo, Dr.
role: Principal Investigator
affiliation: University of Talca
facility: 
country: Chile
citation: Law MR, Morris JK. By how much does fruit and vegetable consumption reduce the risk of ischaemic heart disease: response to commentary. Eur J Clin Nutr. 1999 Nov;53(11):903-4. doi: 10.1038/sj.ejcn.1600944.
PMID: 10557006
citation: Ruggeri ZM. Platelets in atherothrombosis. Nat Med. 2002 Nov;8(11):1227-34. doi: 10.1038/nm1102-1227. No abstract available.
PMID: 12411949
citation: Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007 Dec 13;357(24):2482-94. doi: 10.1056/NEJMra071014. No abstract available.
PMID: 18077812
citation: O'Kennedy N, Crosbie L, van Lieshout M, Broom JI, Webb DJ, Duttaroy AK. Effects of antiplatelet components of tomato extract on platelet function in vitro and ex vivo: a time-course cannulation study in healthy humans. Am J Clin Nutr. 2006 Sep;84(3):570-9. doi: 10.1093/ajcn/84.3.570.
PMID: 16960171
citation: Fuentes E, Forero-Doria O, Carrasco G, Marican A, Santos LS, Alarcon M, Palomo I. Effect of tomato industrial processing on phenolic profile and antiplatelet activity. Molecules. 2013 Sep 17;18(9):11526-36. doi: 10.3390/molecules180911526.
PMID: 24048285
citation: Fuentes E, Pereira J, Alarcon M, Valenzuela C, Perez P, Astudillo L, Palomo I. Protective Mechanisms of S. lycopersicum Aqueous Fraction (Nucleosides and Flavonoids) on Platelet Activation and Thrombus Formation: In Vitro, Ex Vivo and In Vivo Studies. Evid Based Complement Alternat Med. 2013;2013:609714. doi: 10.1155/2013/609714. Epub 2013 Sep 16.
PMID: 24159349
citation: Rodriguez-Azua R, Treuer A, Moore-Carrasco R, Cortacans D, Gutierrez M, Astudillo L, Fuentes E, Palomo I. Effect of tomato industrial processing (different hybrids, paste, and pomace) on inhibition of platelet function in vitro, ex vivo, and in vivo. J Med Food. 2014 Apr;17(4):505-11. doi: 10.1089/jmf.2012.0243. Epub 2013 Dec 10.
PMID: 24325459
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No
provided document: 