<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/NCT04465110</url>
  </required_header>
  <id_info>
    <org_study_id>109-1819-EXP</org_study_id>
    <nct_id>NCT04465110</nct_id>
  </id_info>
  <brief_title>Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses to Exercise in Obese Males</brief_title>
  <official_title>Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses in Obese/Overweight Males During Submaximal Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>California Baptist University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>California Baptist University</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>
      It was demonstrated that acute dietary supplementation with GSE reduced arterial blood&#xD;
      pressure via reduction in Q in obese individuals. However, no studies have investigated the&#xD;
      chronic effects of dietary GSE supplementation on hemodynamic responses during exercise.&#xD;
      Given the fact that obesity is associated with an impaired function of eNOS, the effect of&#xD;
      chronic dietary GSE supplementation on abnormal blood pressure response to exercise and&#xD;
      aortic stiffness (AoS) needs be elucidated. Thus, it is hypothesized that GSE decreases&#xD;
      systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP),&#xD;
      Q, and aortic stiffness at rest and during exercise. This study would determine that this&#xD;
      supplementation may be used as a non-pharmacological intervention to prevent incident&#xD;
      hypertension and cardiovascular events during exercise via enhanced endothelial function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We investigated whether elevated blood pressure and aortic stiffness (AoS) characterized in&#xD;
      obese and overweight males (N=10) are reduced following chronic GSE supplementation during&#xD;
      exercise. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial&#xD;
      pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total vascular&#xD;
      conductance (TVC), and AoS to two submaximal cycling exercises (40% and 60% VO2peak) were&#xD;
      compared 7 days after ingestion of GSE or placebo (PL) within an one week washout period.&#xD;
      Compared with PL, GSE supplementation significantly decreased MAP at rest, 40%, and 60%&#xD;
      workloads. AoS was significantly reduced at rest. Q tended to be decreased, but there was no&#xD;
      significant difference. GSE had no effect on HR, TVC, and SV. Our study indicates that&#xD;
      chronic supplementation with GSE reduces arterial pressure at rest and during exercise&#xD;
      primarily via the combined reduction of AoS and Q. Thus, GSE can be a dietary supplement to&#xD;
      treat augmented blood pressure responses in obese and overweight males at rest and during&#xD;
      exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">April 22, 2020</completion_date>
  <primary_completion_date type="Actual">April 22, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in heart rate at rest and during exercise</measure>
    <time_frame>7 day supplementation</time_frame>
    <description>beats per minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in stroke volume at rest and during exercise</measure>
    <time_frame>7 day supplementation</time_frame>
    <description>volume per stroke</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in cardiac output at rest and during exercise</measure>
    <time_frame>7 day supplementation</time_frame>
    <description>total volume for one minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in systolic blood pressure at rest and during exercise</measure>
    <time_frame>7 day supplementation</time_frame>
    <description>pressure exerted during contraction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in diastolic blood pressure at rest and during exercise</measure>
    <time_frame>7 day supplementation</time_frame>
    <description>pressure exerted during relaxation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in total vascular conductance at rest and during exercise</measure>
    <time_frame>7 day supplementation</time_frame>
    <description>one reported value (cardiac output/mean arterial pressure)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in aortic stiffness at rest</measure>
    <time_frame>7 day supplementation</time_frame>
    <description>Arbitrary unit</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Obesity Adult Onset</condition>
  <arm_group>
    <arm_group_label>GSE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects took a single dose of 600 mg GSE in capsule form through ingestion 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects took a single dose of 600 mg starch in capsule form through ingestion 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Grape Seed Extract</intervention_name>
    <description>Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing Dietary Supplement: Grape seed extract Two capsule grape seed extract (total 600 mg) per day</description>
    <arm_group_label>GSE group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight: 25-29.9 kg/m2&#xD;
&#xD;
          -  Obese: &gt; 30 kg/m2&#xD;
&#xD;
          -  Waist circumference: &gt; 90 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antihypertensive medication&#xD;
&#xD;
          -  Major systemic disease (cancer)&#xD;
&#xD;
          -  Musculoskeletal diseases&#xD;
&#xD;
          -  Cardiovascular diseases or symptoms including chest pain&#xD;
&#xD;
          -  Myocardial infarction&#xD;
&#xD;
          -  Arrhythmias&#xD;
&#xD;
          -  Heart failure&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong-Kyung Kim, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>California Baptist University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Baptist University</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Grape Seed Extract</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>To determine the chronic effects of dietary grape seed extraction, all data collected at rest and during exercise will be shared with other researchers in the publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>All data will be available after publication</ipd_time_frame>
    <ipd_access_criteria>People can access the data based on the copyright of a journal after its publication.</ipd_access_criteria>
    <ipd_url>https://pubmed.ncbi.nlm.nih.gov/</ipd_url>
  </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/NCT04465110
org study id: 109-1819-EXP
nct id: NCT04465110
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It was demonstrated that acute dietary supplementation with GSE reduced arterial blood
      pressure via reduction in Q in obese individuals. However, no studies have investigated the
      chronic effects of dietary GSE supplementation on hemodynamic responses during exercise.
      Given the fact that obesity is associated with an impaired function of eNOS, the effect of
      chronic dietary GSE supplementation on abnormal blood pressure response to exercise and
      aortic stiffness (AoS) needs be elucidated. Thus, it is hypothesized that GSE decreases
      systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP),
      Q, and aortic stiffness at rest and during exercise. This study would determine that this
      supplementation may be used as a non-pharmacological intervention to prevent incident
      hypertension and cardiovascular events during exercise via enhanced endothelial function.
We investigated whether elevated blood pressure and aortic stiffness (AoS) characterized in
      obese and overweight males (N=10) are reduced following chronic GSE supplementation during
      exercise. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial
      pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total vascular
      conductance (TVC), and AoS to two submaximal cycling exercises (40% and 60% VO2peak) were
      compared 7 days after ingestion of GSE or placebo (PL) within an one week washout period.
      Compared with PL, GSE supplementation significantly decreased MAP at rest, 40%, and 60%
      workloads. AoS was significantly reduced at rest. Q tended to be decreased, but there was no
      significant difference. GSE had no effect on HR, TVC, and SV. Our study indicates that
      chronic supplementation with GSE reduces arterial pressure at rest and during exercise
      primarily via the combined reduction of AoS and Q. Thus, GSE can be a dietary supplement to
      treat augmented blood pressure responses in obese and overweight males at rest and during
      exercise.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: change in heart rate at rest and during exercise
time frame: 7 day supplementation
description: beats per minute
measure: change in stroke volume at rest and during exercise
time frame: 7 day supplementation
description: volume per stroke
measure: change in cardiac output at rest and during exercise
time frame: 7 day supplementation
description: total volume for one minute
measure: change in systolic blood pressure at rest and during exercise
time frame: 7 day supplementation
description: pressure exerted during contraction
measure: change in diastolic blood pressure at rest and during exercise
time frame: 7 day supplementation
description: pressure exerted during relaxation
measure: change in total vascular conductance at rest and during exercise
time frame: 7 day supplementation
description: one reported value (cardiac output/mean arterial pressure)
measure: change in aortic stiffness at rest
time frame: 7 day supplementation
description: Arbitrary unit
arm group label: GSE group
arm group type: Experimental
description: Subjects took a single dose of 600 mg GSE in capsule form through ingestion 7 days
arm group label: Placebo group
arm group type: Placebo Comparator
description: Subjects took a single dose of 600 mg starch in capsule form through ingestion 7 days
intervention type: Dietary Supplement
intervention name: Grape Seed Extract
description: Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing Dietary Supplement: Grape seed extract Two capsule grape seed extract (total 600 mg) per day
arm group label: GSE group
arm group label: Placebo group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jong-Kyung Kim, Ph.D
role: Principal Investigator
affiliation: California Baptist University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Grape Seed Extract
sharing ipd: Yes
ipd description: To determine the chronic effects of dietary grape seed extraction, all data collected at rest and during exercise will be shared with other researchers in the publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: All data will be available after publication
ipd access criteria: People can access the data based on the copyright of a journal after its publication.
ipd url: https://pubmed.ncbi.nlm.nih.gov/