<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/NCT03823196</url>
  </required_header>
  <id_info>
    <org_study_id>SNTOL2019</org_study_id>
    <nct_id>NCT03823196</nct_id>
  </id_info>
  <brief_title>Bioavailability, Pharmacokinetic and Mechanistic Study of Sinetrol® Xpur, a Polyphenol-rich Ingredient</brief_title>
  <official_title>Bioavailability, Pharmacokinetic and Mechanistic Study of Sinetrol® Xpur, a Polyphenol-rich Ingredient: an Open-label Study on Overweight Volunteers During a Chronical Supplementation and a Post-supplementation Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fytexia</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fytexia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the metabolization and the bioavailability of&#xD;
      bioactive compounds from Sinetrol® Xpur, a polyphenol-rich ingredient, during a 16-week long&#xD;
      chronical supplementation. It will be investigated the mechanism of action in adipocyte cells&#xD;
      to try to explain the beneficial effects of the ingredient on body composition, especially on&#xD;
      both abdominal subcutaneous and visceral fat mass.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fecal microbiota composition</measure>
    <time_frame>Week 1, Week 8, Week 16 and Week 20 (follow-up)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood microbiota composition</measure>
    <time_frame>Week 1, Week 8, Week 16 and Week 20 (follow-up)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adipose tissue microbiota composition</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adipose tissue lipolysis assessed with glycerol concentration</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adipose tissue lipolysis assessed with free fatty acids concentration</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adipocytes diameters in adipose tissue</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adipose tissue secretion profile assessed by leptin concentration</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adipose tissue secretion profile assessed by adiponectin concentration</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total fat mass assessed by DXA</measure>
    <time_frame>Week 1, Week 16 and Week 20 (follow-up)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total fat-free mass assessed by DXA</measure>
    <time_frame>Week 1, Week 16 and Week 20 (follow-up)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in abdominal fat mass assessed by MRI</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in abdominal subcutaneous fat mass assessed by MRI</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in abdominal visceral fat mass assessed by MRI</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in energy expenditure assessed by indirect calorimetry</measure>
    <time_frame>Week 1, Week 16 and Week 20 (follow-up)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in safety variables assessed by blood pressure variation (systole and diastole in mmHg)</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in safety variables assessed by heart rate variation</measure>
    <time_frame>Week 1 and Week 16</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Verum900</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Verum1800</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Verum900</intervention_name>
    <description>Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 900 mg for 16 weeks</description>
    <arm_group_label>Verum900</arm_group_label>
    <other_name>Sinetrol® Xpur</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Verum1800</intervention_name>
    <description>Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 1800 mg for 16 weeks</description>
    <arm_group_label>Verum1800</arm_group_label>
    <other_name>Sinetrol® Xpur</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated informed consent form&#xD;
&#xD;
          2. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          3. Male and female with 30% min. and 70% max. of each sex, aged range: 20-50 years old&#xD;
&#xD;
          4. Overweight BMI range (27-30)&#xD;
&#xD;
          5. Having a total fat mass (BIA assessment) ≥ 25% for men and ≥ 32% for women&#xD;
&#xD;
          6. In good general health as evidenced by medical history&#xD;
&#xD;
          7. Ability to take oral medication and be willing to adhere to the regimen&#xD;
&#xD;
          8. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study&#xD;
             duration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Metabolic/Chronic disorders or any kind of disease&#xD;
&#xD;
          2. Current use of any medication or food supplement&#xD;
&#xD;
          3. Have in the past been in long-term antibiotherapy (1 month or more) and/or a regular&#xD;
             antiobiotherapy in the past 12 months&#xD;
&#xD;
          4. Former obese with a history of yoyo-effect&#xD;
&#xD;
          5. Have been involved in a weight loss program in the past 12 months or subjected to a&#xD;
             weight reduction surgery&#xD;
&#xD;
          6. Pregnancy or lactation, or women wanting to have a baby&#xD;
&#xD;
          7. Menopausal women&#xD;
&#xD;
          8. Known allergic reactions to components of the supplement, i.e., orange, grapefruit,&#xD;
             guarana and/or caffeine&#xD;
&#xD;
          9. Having started or quit smoking&#xD;
&#xD;
         10. Having a high alcohol consumption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pedro E Alcaraz Ramon</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCAM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCAM</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>October 31, 2019</last_update_submitted>
  <last_update_submitted_qc>October 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</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>Overweight</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/NCT03823196
org study id: SNTOL2019
nct id: NCT03823196
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to investigate the metabolization and the bioavailability of
      bioactive compounds from Sinetrol® Xpur, a polyphenol-rich ingredient, during a 16-week long
      chronical supplementation. It will be investigated the mechanism of action in adipocyte cells
      to try to explain the beneficial effects of the ingredient on body composition, especially on
      both abdominal subcutaneous and visceral fat mass.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient
time frame: Week 1 and Week 16
measure: Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient
time frame: Week 1 and Week 16
measure: Change in fecal microbiota composition
time frame: Week 1, Week 8, Week 16 and Week 20 (follow-up)
measure: Change in blood microbiota composition
time frame: Week 1, Week 8, Week 16 and Week 20 (follow-up)
measure: Change in adipose tissue microbiota composition
time frame: Week 1 and Week 16
measure: Change in adipose tissue lipolysis assessed with glycerol concentration
time frame: Week 1 and Week 16
measure: Change in adipose tissue lipolysis assessed with free fatty acids concentration
time frame: Week 1 and Week 16
measure: Change in adipocytes diameters in adipose tissue
time frame: Week 1 and Week 16
measure: Change in adipose tissue secretion profile assessed by leptin concentration
time frame: Week 1 and Week 16
measure: Change in adipose tissue secretion profile assessed by adiponectin concentration
time frame: Week 1 and Week 16
measure: Change in total fat mass assessed by DXA
time frame: Week 1, Week 16 and Week 20 (follow-up)
measure: Change in total fat-free mass assessed by DXA
time frame: Week 1, Week 16 and Week 20 (follow-up)
measure: Change in abdominal fat mass assessed by MRI
time frame: Week 1 and Week 16
measure: Change in abdominal subcutaneous fat mass assessed by MRI
time frame: Week 1 and Week 16
measure: Change in abdominal visceral fat mass assessed by MRI
time frame: Week 1 and Week 16
measure: Change in energy expenditure assessed by indirect calorimetry
time frame: Week 1, Week 16 and Week 20 (follow-up)
measure: Change in safety variables assessed by blood pressure variation (systole and diastole in mmHg)
time frame: Week 1 and Week 16
measure: Change in safety variables assessed by heart rate variation
time frame: Week 1 and Week 16
arm group label: Verum900
arm group type: Experimental
description: The arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
arm group label: Verum1800
arm group type: Experimental
description: The arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
intervention type: Dietary Supplement
intervention name: Verum900
description: Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 900 mg for 16 weeks
arm group label: Verum900
other name: Sinetrol® Xpur
intervention type: Dietary Supplement
intervention name: Verum1800
description: Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 1800 mg for 16 weeks
arm group label: Verum1800
other name: Sinetrol® Xpur
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pedro E Alcaraz Ramon
role: Principal Investigator
affiliation: UCAM
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No