<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/NCT04444388</url>
  </required_header>
  <id_info>
    <org_study_id>UEM005</org_study_id>
    <nct_id>NCT04444388</nct_id>
  </id_info>
  <brief_title>Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome</brief_title>
  <official_title>Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome: Effects on Acute and Adaptive Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Europea de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Europea de Madrid</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>
      It has recently been suggested that cocoa may improve exercise performance and recovery. This&#xD;
      study aim to evaluate the plasma and fecal metabolome after 10 weeks of cocoa supplementation&#xD;
      during the training period in recreational athletes to detect possible metabolites involved&#xD;
      in the observed benefits of cocoa in athletes&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fecal microbiota</measure>
    <time_frame>Changes from baseline to 10 weeks of intervention</time_frame>
    <description>Abundance of bacterial taxa determined by 16SRNAr gene sequencing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fecal metabolome profile</measure>
    <time_frame>Changes from baseline to 10 weeks of intervention</time_frame>
    <description>Abundance of fecal metabolites, metabolic networks, and metabolic pathways determined by High Pressure Liquid Chromatography-Mass Spectrometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma metabolome profile</measure>
    <time_frame>Changes from baseline to 10 weeks of intervention</time_frame>
    <description>Abundance of blood metabolites, metabolic networks, and metabolic pathways activity determined by High Pressure Liquid Chromatography-Mass Spectrometry</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy Athletes</condition>
  <arm_group>
    <arm_group_label>Cocoa group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 g/day of flavonoid-rich defatted cocoa for 10 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>5 g/day of maltodextrin for 10 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>cocoa</intervention_name>
    <description>Sachets of 5 grams of cocoa daily supplementation</description>
    <arm_group_label>Cocoa group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sachets of 5 grams of maltodextrin daily supplementation</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45 years of age&#xD;
&#xD;
          -  high physical condition (VO2 ≥ 55 ml/kg/min)&#xD;
&#xD;
          -  BMI 18-25 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  antibiotics intake during 3 months prior to the study,&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  nutritional complements&#xD;
&#xD;
          -  ergogenic complements&#xD;
&#xD;
          -  prebiotics&#xD;
&#xD;
          -  probiotics&#xD;
&#xD;
          -  vegetarian or vegan diet&#xD;
&#xD;
          -  chronic medication&#xD;
&#xD;
          -  gastrointestinal surgery&#xD;
&#xD;
          -  Any diagnosed disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mar Larrosa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Europea de Madrid</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad Europea de Madrid</name>
      <address>
        <city>Villaviciosa de Odón</city>
        <state>Madrid</state>
        <zip>28670</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Europea de Madrid</investigator_affiliation>
    <investigator_full_name>Mar Larrosa</investigator_full_name>
    <investigator_title>Tenure Professor</investigator_title>
  </responsible_party>
  <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/NCT04444388
org study id: UEM005
nct id: NCT04444388
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It has recently been suggested that cocoa may improve exercise performance and recovery. This
      study aim to evaluate the plasma and fecal metabolome after 10 weeks of cocoa supplementation
      during the training period in recreational athletes to detect possible metabolites involved
      in the observed benefits of cocoa in athletes
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Investigator, Outcomes Assessor)
measure: Fecal microbiota
time frame: Changes from baseline to 10 weeks of intervention
description: Abundance of bacterial taxa determined by 16SRNAr gene sequencing
measure: Fecal metabolome profile
time frame: Changes from baseline to 10 weeks of intervention
description: Abundance of fecal metabolites, metabolic networks, and metabolic pathways determined by High Pressure Liquid Chromatography-Mass Spectrometry
measure: Plasma metabolome profile
time frame: Changes from baseline to 10 weeks of intervention
description: Abundance of blood metabolites, metabolic networks, and metabolic pathways activity determined by High Pressure Liquid Chromatography-Mass Spectrometry
arm group label: Cocoa group
arm group type: Experimental
description: 5 g/day of flavonoid-rich defatted cocoa for 10 weeks
arm group label: Placebo group
arm group type: Placebo Comparator
description: 5 g/day of maltodextrin for 10 weeks
intervention type: Dietary Supplement
intervention name: cocoa
description: Sachets of 5 grams of cocoa daily supplementation
arm group label: Cocoa group
intervention type: Dietary Supplement
intervention name: Placebo
description: Sachets of 5 grams of maltodextrin daily supplementation
arm group label: Placebo group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mar Larrosa, PhD
role: Principal Investigator
affiliation: Universidad Europea de Madrid
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Europea de Madrid
investigator full name: Mar Larrosa
investigator title: Tenure Professor
sharing ipd: No