<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/NCT03828006</url>
  </required_header>
  <id_info>
    <org_study_id>BIO-LIP-01-18</org_study_id>
    <nct_id>NCT03828006</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk</brief_title>
  <official_title>Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bioksan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Analysis and Research Network, S.L</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bioksan</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>
      This clinical trial seeks to verify the efficacy of a red rice yeast dietary supplement in&#xD;
      the decrease of cardiovascular risk, by assessing variables related with cardiovascular risk&#xD;
      as levels of cholesterol, triglycerides and transaminases among other, in two groups of&#xD;
      participants that will be taking either the dietary supplement or a placebo during a six&#xD;
      months period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systematic Coronary Risk Evaluation (SCORE)</measure>
    <time_frame>Changes in the score from the baseline, at 3 and 6 months.</time_frame>
    <description>This scale estimates the 10 year risk of fatal CVD.&#xD;
The risk is estimated with a High &amp; Low cardiovascular Risk Charts based on gender, age, total cholesterol, systolic blood pressure and smoking status, with relative risk chart, qualifiers and instructions. High risk or low risk table depends on whether the person lives in a high or low risk country.&#xD;
There possible scores goes from 0 to 47 in the high risk table, and 0 to 26 in the low risk table. Where lower values represent lower risk and higher values higher risk.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arteriosclerotic Cardiovascular Disease Algorithm (ASCVD)</measure>
    <time_frame>Changes in the score from the baseline, at 3 and 6 months.</time_frame>
    <description>Calculates 10-year risk of heart disease or stroke using the ASCVD algorithm published in 2013 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines on de Assessment of Cardiovascular Risk.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Registre Gironi del Cor (REGICOR)</measure>
    <time_frame>Changes in the score from the baseline, at 3 and 6 months.</time_frame>
    <description>The scale measures the probability of having cardiovascular disease in 10 years.&#xD;
The probability is estimated with age, sex, smoking status, diabetic or not, total Cholesterol (mg/dl), HDL cholesterol (mg/dl), systolic blood pressure (mmHg) and diastolic blood pressure (mmHg).&#xD;
Possible risk values are divided in 5 categories: low &lt;5%, moderate 6-9%, medium 10-19%, high 20-38%, very high &gt;39%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in LDL cholesterol levels in blood</measure>
    <time_frame>Changes in the cholesterol levels from the baseline, at 3 and 6 months.</time_frame>
    <description>LDL in blood measured in mg/dL Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HDL cholesterol levels in blood</measure>
    <time_frame>Changes in the cholesterol levels from the baseline, at 3 and 6 months.</time_frame>
    <description>HDL cholesterol will be measured in mg/dl Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in triglycerides levels in blood</measure>
    <time_frame>Changes in the triglyceride levels from the baseline, at 3 and 6 months.</time_frame>
    <description>Triglycerides will be measured in mg/dl Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in lipoprotein levels in blood</measure>
    <time_frame>Changes in the lipoprotein levels from the baseline, at 3 and 6 months.</time_frame>
    <description>Lipoproteins will be measured in mg/dl Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of glycosylated hemoglobin in blood</measure>
    <time_frame>Changes in the lipoprotein levels from the baseline, at 3 and 6 months.</time_frame>
    <description>Glycosylated Hemoglobin (HbA1c) will be measured as % in blood Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine Transaminase (ALT) levels</measure>
    <time_frame>Changes in the lipoprotein levels from the baseline, at 3 and 6 months.</time_frame>
    <description>Levels of ALT Transaminase measured in IU/L. Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Number of adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic adherence</measure>
    <time_frame>At the 6 month visit</time_frame>
    <description>Data will be collected by the investigator at participant visits with a unique question about percentage of intake. It will be considered a good compliance if the 80% of the medication has been taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morisky-Green scale</measure>
    <time_frame>At the 6 month visit</time_frame>
    <description>The Morisky-Green scale measures treatment adherence with four yes or no questions.&#xD;
In which yes punctuates 0 and no punctuates 1.&#xD;
Possible result values goes from 0 to 4, being 0 less adherence and 4 more adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recount of returned product</measure>
    <time_frame>At the 6 month visit</time_frame>
    <description>The number of returned product will be counted</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Low-Moderate Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Active Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One tablet per day through oral administration of a dietary supplement containing red rice yeast as the main active ingredient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One tablet per day of placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Red Rice Yeast</intervention_name>
    <description>Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months</description>
    <arm_group_label>Active Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Group</intervention_name>
    <description>Participants of this group will take one tablet of placebo per day for a period of six months</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or older&#xD;
&#xD;
          -  Body Mass Index (BMI) between 18.5 y 29.9.&#xD;
&#xD;
          -  LDL-c levels between 100mg/dL and 160mg/dL&#xD;
&#xD;
          -  10 year estimated cardiovascular risk assessed by the ASCVD less than 20%&#xD;
&#xD;
          -  Accepts to participate and sings Informed Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of cardiovascular diseases.&#xD;
&#xD;
          -  Patients with secondary hyperlipidemia caused by diabetes mellitus, or kidney, liver&#xD;
             or thyroid diseases.&#xD;
&#xD;
          -  Patients with muscle diseases&#xD;
&#xD;
          -  Patients undergoing pharmacological treatment with any of the following: lipid&#xD;
             lowering agents, antifungal, macrolides, or hormone replacement therapy in progress or&#xD;
             during the last 2 months.&#xD;
&#xD;
          -  Patients with proven intolerance with the components present in the dietary&#xD;
             supplement.&#xD;
&#xD;
          -  Patients with any other concomitant disease that to the researcher's criteria are not&#xD;
             susceptible to participate in the study.&#xD;
&#xD;
          -  Woman that are pregnant, in breastfeeding period or with a possibility of starting a&#xD;
             pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospitales San Roque</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <state>Canarias</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitari de València</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</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>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Red yeast rice</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03828006
org study id: BIO-LIP-01-18
nct id: NCT03828006
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This clinical trial seeks to verify the efficacy of a red rice yeast dietary supplement in
      the decrease of cardiovascular risk, by assessing variables related with cardiovascular risk
      as levels of cholesterol, triglycerides and transaminases among other, in two groups of
      participants that will be taking either the dietary supplement or a placebo during a six
      months period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Systematic Coronary Risk Evaluation (SCORE)
time frame: Changes in the score from the baseline, at 3 and 6 months.
description: This scale estimates the 10 year risk of fatal CVD.
The risk is estimated with a High & Low cardiovascular Risk Charts based on gender, age, total cholesterol, systolic blood pressure and smoking status, with relative risk chart, qualifiers and instructions. High risk or low risk table depends on whether the person lives in a high or low risk country.
There possible scores goes from 0 to 47 in the high risk table, and 0 to 26 in the low risk table. Where lower values represent lower risk and higher values higher risk.
measure: Arteriosclerotic Cardiovascular Disease Algorithm (ASCVD)
time frame: Changes in the score from the baseline, at 3 and 6 months.
description: Calculates 10-year risk of heart disease or stroke using the ASCVD algorithm published in 2013 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines on de Assessment of Cardiovascular Risk.
measure: Registre Gironi del Cor (REGICOR)
time frame: Changes in the score from the baseline, at 3 and 6 months.
description: The scale measures the probability of having cardiovascular disease in 10 years.
The probability is estimated with age, sex, smoking status, diabetic or not, total Cholesterol (mg/dl), HDL cholesterol (mg/dl), systolic blood pressure (mmHg) and diastolic blood pressure (mmHg).
Possible risk values are divided in 5 categories: low <5%, moderate 6-9%, medium 10-19%, high 20-38%, very high >39%
measure: Changes in LDL cholesterol levels in blood
time frame: Changes in the cholesterol levels from the baseline, at 3 and 6 months.
description: LDL in blood measured in mg/dL Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
measure: Changes in HDL cholesterol levels in blood
time frame: Changes in the cholesterol levels from the baseline, at 3 and 6 months.
description: HDL cholesterol will be measured in mg/dl Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
measure: Changes in triglycerides levels in blood
time frame: Changes in the triglyceride levels from the baseline, at 3 and 6 months.
description: Triglycerides will be measured in mg/dl Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
measure: Changes in lipoprotein levels in blood
time frame: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
description: Lipoproteins will be measured in mg/dl Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
measure: Levels of glycosylated hemoglobin in blood
time frame: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
description: Glycosylated Hemoglobin (HbA1c) will be measured as % in blood Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
measure: Alanine Transaminase (ALT) levels
time frame: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
description: Levels of ALT Transaminase measured in IU/L. Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
measure: Adverse Events
time frame: Through study completion, an average of 9 months
description: Number of adverse events.
measure: Therapeutic adherence
time frame: At the 6 month visit
description: Data will be collected by the investigator at participant visits with a unique question about percentage of intake. It will be considered a good compliance if the 80% of the medication has been taken.
measure: Morisky-Green scale
time frame: At the 6 month visit
description: The Morisky-Green scale measures treatment adherence with four yes or no questions.
In which yes punctuates 0 and no punctuates 1.
Possible result values goes from 0 to 4, being 0 less adherence and 4 more adherence.
measure: Recount of returned product
time frame: At the 6 month visit
description: The number of returned product will be counted
arm group label: Active Group
arm group type: Experimental
description: One tablet per day through oral administration of a dietary supplement containing red rice yeast as the main active ingredient
arm group label: Placebo Group
arm group type: Placebo Comparator
description: One tablet per day of placebo.
intervention type: Dietary Supplement
intervention name: Red Rice Yeast
description: Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months
arm group label: Active Group
intervention type: Other
intervention name: Placebo Group
description: Participants of this group will take one tablet of placebo per day for a period of six months
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Red yeast rice