<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/NCT04434534</url>
  </required_header>
  <id_info>
    <org_study_id>5483/18</org_study_id>
    <nct_id>NCT04434534</nct_id>
  </id_info>
  <brief_title>Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness</brief_title>
  <official_title>Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness in Overwheight or Obese Individuals: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Cardiologia do Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Cardiologia do Rio Grande do Sul</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 study evaluates the consumption of Açaí Juçara pulp in endothelial function and arterial&#xD;
      stiffness in overwheight and obese individuals. Half of participants will receive a&#xD;
      hipocaloric diet and two Açaí Juçara pulps for daily consumption, while the other half will&#xD;
      receive just a hipocaloric diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is the most prevalent nutritional disease and a growing public health problem&#xD;
      worldwide. This clinical condition is an established risk factor for cardiovascular diseases.&#xD;
&#xD;
      Açaí Juçara is a brazilian fruit, rich in antioxidants, like anthocyanin. This compound have&#xD;
      antioxidative and vasodilatory properties. Prospective studies have shown that the&#xD;
      antioxidant present in berries can improve vascular health, like endothelial function,&#xD;
      measured by Flow Mediated Dilatation (FMD) and arterial stiffness, measured by Pulse Wave&#xD;
      Velocity (PWV).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">December 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 10, 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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flow-mediated Dilation (FMD)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The non-invasive evaluation of endothelial function in the brachial artery will be performed at the Laboratory of Clinical Investigation of the Institute of Cardiology of Rio Grande do Sul. The images will be captured by a trained professional in the method using ultrasonography equipament with a linear transducer. The acquisition of the image will be through the program Ulead Video Studio (EasyCap). The protocol consist in 1 minute of baseline recording of the arterial flow diameter, followed by 5 minutes of reactive hyperemia (cuff occlusion in the forearm) and then 3 minutes recording after cuff deflation. The exams will be record in a video, and later analyzed through the Cardiovascular Suite software.&#xD;
The FMD will be evaluated before the beginning of the diet and after 12 weeks of diet.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulse Wave Velocity</measure>
    <time_frame>12 weeks</time_frame>
    <description>The calibrated and validated Mobil-O-Graph® portable monitor will be used. This module is connected to a computer to record the brachial pulse wave. It performs pulse wave analysis based on the oscillometric method. The arterial pulsation generates pressure oscillations, which are transmitted to the blood pressure cuff and measured by the transducer to be interpreted by a specific software, recording the pulse wave of the brachial artery and deriving a pulse wave from the aortic arch.&#xD;
All measurements will be performed by the same evaluator on the right side of the volunteer. Participants will be instructed to be in 12 hours os fasting.&#xD;
The pulse wave velocity will be evaluated before the beginning of the diet and after 12 weeks of diet.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Hipocaloric Diet with Açaí Juçara</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individualized diet plans calculated for each participant, reducing 500-1000 daily calories, including 200g of Açaí Juçara (2 pulps).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hipocaloric Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individualized diet plans calculated for each participant, reducing 500-1000 daily calories.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hipocaloric Diet with Açaí Juçara</intervention_name>
    <description>Daily consumption of Açaí Juçara pulp (200g) and nutritional adequacy of meals in individualized diet plans calculated for each participant.</description>
    <arm_group_label>Hipocaloric Diet with Açaí Juçara</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hipocaloric Diet</intervention_name>
    <description>Nutritional adequacy of meals in individualized diet plans calculated for each participant.</description>
    <arm_group_label>Hipocaloric Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sedentary lifestyle&#xD;
&#xD;
          -  Overwheight or obesity &quot;1&quot; diagnostic (BMI &gt;25kg/m² and &lt;35kg/m²)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcoolism&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Diagnostic of Diabetes Mellitus or Coronary Artery Disease&#xD;
&#xD;
          -  Use of Statin Therapy&#xD;
&#xD;
          -  Cardiovascular diseases&#xD;
&#xD;
          -  Infectious Disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tainah Ortiz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto de Cardiologia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tainah Ortiz</last_name>
    <phone>55 51 999171990</phone>
    <email>tainahortiz05@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexandre Lehnen, PhD</last_name>
    <phone>55 51 999768092</phone>
    <email>amlehnen@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90620001</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandre M Lehnen, PhD</last_name>
      <phone>+555199976809</phone>
      <email>amlehnen@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Tainah Ortiz</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endhothelial function</keyword>
  <keyword>Anthocyanins</keyword>
  <keyword>Arterial stiffness</keyword>
  <keyword>Açaí Juçara</keyword>
  <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/NCT04434534
org study id: 5483/18
nct id: NCT04434534
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the consumption of Açaí Juçara pulp in endothelial function and arterial
      stiffness in overwheight and obese individuals. Half of participants will receive a
      hipocaloric diet and two Açaí Juçara pulps for daily consumption, while the other half will
      receive just a hipocaloric diet.
Obesity is the most prevalent nutritional disease and a growing public health problem
      worldwide. This clinical condition is an established risk factor for cardiovascular diseases.

      Açaí Juçara is a brazilian fruit, rich in antioxidants, like anthocyanin. This compound have
      antioxidative and vasodilatory properties. Prospective studies have shown that the
      antioxidant present in berries can improve vascular health, like endothelial function,
      measured by Flow Mediated Dilatation (FMD) and arterial stiffness, measured by Pulse Wave
      Velocity (PWV).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Flow-mediated Dilation (FMD)
time frame: 12 weeks
description: The non-invasive evaluation of endothelial function in the brachial artery will be performed at the Laboratory of Clinical Investigation of the Institute of Cardiology of Rio Grande do Sul. The images will be captured by a trained professional in the method using ultrasonography equipament with a linear transducer. The acquisition of the image will be through the program Ulead Video Studio (EasyCap). The protocol consist in 1 minute of baseline recording of the arterial flow diameter, followed by 5 minutes of reactive hyperemia (cuff occlusion in the forearm) and then 3 minutes recording after cuff deflation. The exams will be record in a video, and later analyzed through the Cardiovascular Suite software.
The FMD will be evaluated before the beginning of the diet and after 12 weeks of diet.
measure: Pulse Wave Velocity
time frame: 12 weeks
description: The calibrated and validated Mobil-O-Graph® portable monitor will be used. This module is connected to a computer to record the brachial pulse wave. It performs pulse wave analysis based on the oscillometric method. The arterial pulsation generates pressure oscillations, which are transmitted to the blood pressure cuff and measured by the transducer to be interpreted by a specific software, recording the pulse wave of the brachial artery and deriving a pulse wave from the aortic arch.
All measurements will be performed by the same evaluator on the right side of the volunteer. Participants will be instructed to be in 12 hours os fasting.
The pulse wave velocity will be evaluated before the beginning of the diet and after 12 weeks of diet.
arm group label: Hipocaloric Diet with Açaí Juçara
arm group type: Experimental
description: Individualized diet plans calculated for each participant, reducing 500-1000 daily calories, including 200g of Açaí Juçara (2 pulps).
arm group label: Hipocaloric Diet
arm group type: Active Comparator
description: Individualized diet plans calculated for each participant, reducing 500-1000 daily calories.
intervention type: Dietary Supplement
intervention name: Hipocaloric Diet with Açaí Juçara
description: Daily consumption of Açaí Juçara pulp (200g) and nutritional adequacy of meals in individualized diet plans calculated for each participant.
arm group label: Hipocaloric Diet with Açaí Juçara
intervention type: Other
intervention name: Hipocaloric Diet
description: Nutritional adequacy of meals in individualized diet plans calculated for each participant.
arm group label: Hipocaloric Diet
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tainah Ortiz
role: Principal Investigator
affiliation: Instituto de Cardiologia
last name: Tainah Ortiz
phone: 55 51 999171990
email: tainahortiz05@gmail.com
last name: Alexandre Lehnen, PhD
phone: 55 51 999768092
email: amlehnen@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No