<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/NCT03826914</url>
  </required_header>
  <id_info>
    <org_study_id>CardioFLex Q10</org_study_id>
    <nct_id>NCT03826914</nct_id>
  </id_info>
  <brief_title>The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults</brief_title>
  <official_title>The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</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>
      Cardiovascular diseases (CVD), primarily heart disease and stroke, are the leading causes of&#xD;
      death and prescription drug use in Canada. Research on certain dietary supplements looks&#xD;
      promising as a way to help reduce CVD risk factors. Studies show that supplementation of&#xD;
      certain nutrients such as antioxidants, amino acids, electrolytes, vitamins and minerals may&#xD;
      effectively reduce cardiovascular risk factors. The dietary supplement CardioFlex Q10, which&#xD;
      is high in the aforementioned components, was developed to help regulate the body's&#xD;
      production of cholesterol, strengthen the arteries and heart, and reverse oxidation.&#xD;
&#xD;
      The overall objective of this study is to determine if 90 days of supplementing with&#xD;
      CardioFlex Q10 can reduce CVD risk factors in adults, independent of other dietary or&#xD;
      physical activity changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine whether or not daily supplementation with the&#xD;
      dietary supplement CardioFlex Q10 for 90 days can reduce cardiovascular risk factors in&#xD;
      healthy adults. The health markers that will be tested include the participant's waist&#xD;
      circumference, body weight, body mass index (BMI), atherosclerosis risk factors (blood&#xD;
      pressure, plethysmogram (PTG) wave form, heart rate variability, accelerated plethysmograph&#xD;
      (APG) type (biological age of arteries)), and blood work including total plasma lipid profile&#xD;
      (total cholesterol (TC), high density lipoprotein (HDL), low density lipoprotein (LDL),&#xD;
      triglycerides (TGs)), kidney and liver function (alanine aminotransferase (ALT), aspartate&#xD;
      aminotransferase (AST), Lactate dehydrogenase (LDH), Blood Urea Nitrogen (BUN), creatinine),&#xD;
      and inflammatory and endothelial function biomarkers (C-reactive protein (CRP), Interleukin-6&#xD;
      (IL-6), soluble intercellular cell adhesion molecule-1 (sICAM-1), soluble vascular cell&#xD;
      adhesion molecule-1 (sVCAM-1) ).&#xD;
&#xD;
      All health markers will be tested the day before starting the study and the day after the&#xD;
      study is completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 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>
    <intervention_model_description>A 90-day double blinded controlled clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The selected participants will be randomly assigned in equal numbers to the experimental or control group. Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day. Participants in the control group will be given a flavored 10g placebo that looks and tastes exactly like Cardioflex. Participants will be instructed to consume the beverage in 500mL of water upon waking each morning, prior to eating or drinking anything else.&#xD;
The clinical trial is double blinded so neither the participants or investigators will know which experimental group they are in until the data collection period is over.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline of Total Cholesterol After 90 Days</measure>
    <time_frame>Baseline and 90 days</time_frame>
    <description>Total cholesterol is the total amount of cholesterol in the blood. Change = Day 90 score - baseline score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Variability</measure>
    <time_frame>Baseline and day 90</time_frame>
    <description>Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Cardiovascular Abnormalities</condition>
  <condition>Heart Attack</condition>
  <condition>Stroke</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in the control group will be given a flavoured 10g placebo that looks and tastes exactly like Cardioflex.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>CardioFlex Q10</intervention_name>
    <description>CardioFlex Q10 is a cardiovascular health supplement developed to increase collagen production, repair connective tissues, and help the body metabolize fats and protein. CardioFlex Q10 contains high amounts of lysine, proline and vitamin C, which the body requires to produce connective tissue (collagen). CardioFlex Q10 also includes additional supporting nutrients such as vitamin E, selenium, bio flavonoids, Coenzyme Q10 (Ubiqionol) and magnesium. The ingredients in CardioFlex Q10 help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 30-65&#xD;
&#xD;
          -  An accelerated plethysmograph (APG) type (biological age of arteries) of D, E, F or G&#xD;
             and/or a high density lipoprotein (HDL) to total cholesterol (TC) ratio of ≤24 percent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have used prescription cholesterol or blood pressure medication in the last 3 months&#xD;
&#xD;
          -  Perform more then 150 minutes of moderate to rigorous activity per week&#xD;
&#xD;
          -  Pregnant or planning on getting pregnant during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Semone Myrie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Richardson Centre for Functional Foods and Nutraceuticals</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3T 6C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Myers J. Cardiology patient pages. Exercise and cardiovascular health. Circulation. 2003 Jan 7;107(1):e2-5. doi: 10.1161/01.cir.0000048890.59383.8d. No abstract available.</citation>
    <PMID>12515760</PMID>
  </reference>
  <reference>
    <citation>Nunez-Cordoba JM, Martinez-Gonzalez MA. Antioxidant vitamins and cardiovascular disease. Curr Top Med Chem. 2011;11(14):1861-9. doi: 10.2174/156802611796235143.</citation>
    <PMID>21506930</PMID>
  </reference>
  <reference>
    <citation>Manson JE, Gaziano JM, Jonas MA, Hennekens CH. Antioxidants and cardiovascular disease: a review. J Am Coll Nutr. 1993 Aug;12(4):426-32. doi: 10.1080/07315724.1993.10718332.</citation>
    <PMID>8409105</PMID>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <results_first_submitted>September 8, 2020</results_first_submitted>
  <results_first_submitted_qc>October 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 29, 2020</results_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dietary supplements</keyword>
  <keyword>cardiovascular diseases</keyword>
  <keyword>heart attack</keyword>
  <keyword>stroke</keyword>
  <keyword>hypertension</keyword>
  <keyword>amino acids</keyword>
  <keyword>electrolytes</keyword>
  <keyword>antioxidants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Cardiovascular Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03826914/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment of study participants employed several strategies including email, flyers, and in-person presentations.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Experimental Group</title>
          <description>Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.&#xD;
CardioFlex Q10: CardioFlex Q10 is a cardiovascular health supplement developed to increase collagen production, repair connective tissues, and help the body metabolize fats and protein. CardioFlex Q10 contains high amounts of lysine, proline and vitamin C, which the body requires to produce connective tissue (collagen). CardioFlex Q10 also includes additional supporting nutrients such as vitamin E, selenium, bio flavonoids, Coenzyme Q10 (Ubiqionol) and magnesium. The ingredients in CardioFlex Q10 help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Participants in the control group will be given a flavoured 10g maltodextrin placebo that looks and tastes exactly like Cardioflex Q10.&#xD;
Placebo: Maltodextrin placebo that looks and tastes identical to CardioFLex Q10</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>69 participants started the clinical trial, 35 in the Cardioflex group and 34 in the Placebo group.</population>
      <group_list>
        <group group_id="B1">
          <title>Experimental Group</title>
          <description>Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.&#xD;
CardioFlex Q10: CardioFlex Q10 is a cardiovascular health supplement developed to increase collagen production, repair connective tissues, and help the body metabolize fats and protein. CardioFlex Q10 contains high amounts of lysine, proline and vitamin C, which the body requires to produce connective tissue (collagen). CardioFlex Q10 also includes additional supporting nutrients such as vitamin E, selenium, bio flavonoids, Coenzyme Q10 (Ubiqionol) and magnesium. The ingredients in CardioFlex Q10 help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Participants in the control group will be given a flavoured 10g maltodextrin placebo that looks and tastes exactly like Cardioflex Q10.&#xD;
Placebo: Maltodextrin placebo that looks and tastes identical to CardioFLex Q10</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
            <count group_id="B2" value="34"/>
            <count group_id="B3" value="69"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>2 participants (1 in cardioflex group and 1 in placebo group) did not complete the study for personal reasons not related to the study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline of Total Cholesterol After 90 Days</title>
        <description>Total cholesterol is the total amount of cholesterol in the blood. Change = Day 90 score - baseline score.</description>
        <time_frame>Baseline and 90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cardioflex Group</title>
            <description>Participants were given 1 serving (10g) of Cardioflex each day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Participants in the placebo group were given 10g of a maltodextrin placebo per day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline of Total Cholesterol After 90 Days</title>
          <description>Total cholesterol is the total amount of cholesterol in the blood. Change = Day 90 score - baseline score.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.57" spread="1.06"/>
                    <measurement group_id="O2" value="-1.09" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.042</p_value>
            <p_value_desc>The threshold of significance was P=0.05</p_value_desc>
            <method>Anaylsis of Covariance</method>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.846</ci_lower_limit>
            <ci_upper_limit>-0.015</ci_upper_limit>
            <estimate_desc>Placebo - Cardioflex</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Heart Rate Variability</title>
        <description>Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score</description>
        <time_frame>Baseline and day 90</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cardioflex</title>
            <description>Participants in the Cardioflex group were given 1 serving (10g) of Cardioflex each day.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants in the placebo group were given 10g of a maltodextrin placebo each day.</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate Variability</title>
          <description>Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score</description>
          <units>ms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.49" spread="10.86"/>
                    <measurement group_id="O2" value="-6.27" spread="10.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.04</p_value>
            <p_value_desc>The threshold of significance was P=0.05</p_value_desc>
            <method>Anaylsis of Covariance</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.772</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.2</ci_lower_limit>
            <ci_upper_limit>-2.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored over the 90 day study period.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Experimental Group</title>
          <description>Participants were given one serving (10g) of cardioflex daily for 90 consecutive days.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Participants were given one serving of an isocaloric maltodextrin placebo daily for 90 consecutive days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Semone Myrie</name_or_title>
      <organization>University of Manitoba</organization>
      <phone>(204) 474-7290</phone>
      <email>semone.myrie@umanitoba.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03826914
org study id: CardioFLex Q10
nct id: NCT03826914
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular diseases (CVD), primarily heart disease and stroke, are the leading causes of
      death and prescription drug use in Canada. Research on certain dietary supplements looks
      promising as a way to help reduce CVD risk factors. Studies show that supplementation of
      certain nutrients such as antioxidants, amino acids, electrolytes, vitamins and minerals may
      effectively reduce cardiovascular risk factors. The dietary supplement CardioFlex Q10, which
      is high in the aforementioned components, was developed to help regulate the body's
      production of cholesterol, strengthen the arteries and heart, and reverse oxidation.

      The overall objective of this study is to determine if 90 days of supplementing with
      CardioFlex Q10 can reduce CVD risk factors in adults, independent of other dietary or
      physical activity changes.
The purpose of this study is to determine whether or not daily supplementation with the
      dietary supplement CardioFlex Q10 for 90 days can reduce cardiovascular risk factors in
      healthy adults. The health markers that will be tested include the participant's waist
      circumference, body weight, body mass index (BMI), atherosclerosis risk factors (blood
      pressure, plethysmogram (PTG) wave form, heart rate variability, accelerated plethysmograph
      (APG) type (biological age of arteries)), and blood work including total plasma lipid profile
      (total cholesterol (TC), high density lipoprotein (HDL), low density lipoprotein (LDL),
      triglycerides (TGs)), kidney and liver function (alanine aminotransferase (ALT), aspartate
      aminotransferase (AST), Lactate dehydrogenase (LDH), Blood Urea Nitrogen (BUN), creatinine),
      and inflammatory and endothelial function biomarkers (C-reactive protein (CRP), Interleukin-6
      (IL-6), soluble intercellular cell adhesion molecule-1 (sICAM-1), soluble vascular cell
      adhesion molecule-1 (sVCAM-1) ).

      All health markers will be tested the day before starting the study and the day after the
      study is completed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A 90-day double blinded controlled clinical trial
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: The selected participants will be randomly assigned in equal numbers to the experimental or control group. Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day. Participants in the control group will be given a flavored 10g placebo that looks and tastes exactly like Cardioflex. Participants will be instructed to consume the beverage in 500mL of water upon waking each morning, prior to eating or drinking anything else.
The clinical trial is double blinded so neither the participants or investigators will know which experimental group they are in until the data collection period is over.
measure: Change From Baseline of Total Cholesterol After 90 Days
time frame: Baseline and 90 days
description: Total cholesterol is the total amount of cholesterol in the blood. Change = Day 90 score - baseline score.
measure: Heart Rate Variability
time frame: Baseline and day 90
description: Heart rate variability is a measure of the variation in time between each heartbeat. Change = day 90 score - baseline score
arm group label: Experimental group
arm group type: Experimental
description: Participants in the experimental group will be given 1 serving (10g) of Cardioflex each day.
arm group label: Control Group
arm group type: Placebo Comparator
description: Participants in the control group will be given a flavoured 10g placebo that looks and tastes exactly like Cardioflex.
intervention type: Dietary Supplement
intervention name: CardioFlex Q10
description: CardioFlex Q10 is a cardiovascular health supplement developed to increase collagen production, repair connective tissues, and help the body metabolize fats and protein. CardioFlex Q10 contains high amounts of lysine, proline and vitamin C, which the body requires to produce connective tissue (collagen). CardioFlex Q10 also includes additional supporting nutrients such as vitamin E, selenium, bio flavonoids, Coenzyme Q10 (Ubiqionol) and magnesium. The ingredients in CardioFlex Q10 help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation.
arm group label: Experimental group
intervention type: Dietary Supplement
intervention name: Placebo
description: Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10
arm group label: Control Group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Semone Myrie, PhD
role: Principal Investigator
affiliation: University of Manitoba
facility: 
country: Canada
citation: Myers J. Cardiology patient pages. Exercise and cardiovascular health. Circulation. 2003 Jan 7;107(1):e2-5. doi: 10.1161/01.cir.0000048890.59383.8d. No abstract available.
PMID: 12515760
citation: Nunez-Cordoba JM, Martinez-Gonzalez MA. Antioxidant vitamins and cardiovascular disease. Curr Top Med Chem. 2011;11(14):1861-9. doi: 10.2174/156802611796235143.
PMID: 21506930
citation: Manson JE, Gaziano JM, Jonas MA, Hennekens CH. Antioxidants and cardiovascular disease: a review. J Am Coll Nutr. 1993 Aug;12(4):426-32. doi: 10.1080/07315724.1993.10718332.
PMID: 8409105
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Cardiovascular Diseases
mesh term: Myocardial Infarction
mesh term: Cardiovascular Abnormalities
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 