<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/NCT04506749</url>
  </required_header>
  <id_info>
    <org_study_id>UCAMCFE-00015</org_study_id>
    <nct_id>NCT04506749</nct_id>
  </id_info>
  <brief_title>To Evaluate the Efficacy of a Nutraceutical in Reducing Cardiovascular Risk in Healthy Subjects</brief_title>
  <acronym>JC</acronym>
  <official_title>Clinical Trial to Evaluate the Efficacy of a Nutraceutical Versus Placebo in Reducing Cardiovascular Risk in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Single-blind, double-blind, controlled, randomized clinical trial of two parallel branches&#xD;
      depending on the product consumed (experimental product and placebo product) and&#xD;
      single-center with the objective of evaluating the effect of the investigational product on&#xD;
      cardiovascular risk reduction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects who meet the selection criteria will make a total of two visits to the research&#xD;
      laboratory and will carry out the tests established in the protocol. Subsequently, a&#xD;
      statistical analysis will be performed with the variables measured in the study to obtain&#xD;
      results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2019</start_date>
  <completion_date type="Actual">September 18, 2020</completion_date>
  <primary_completion_date type="Actual">August 14, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Cholesterol</measure>
    <time_frame>It is measured on an empty stomach, change after 56 days of consumption.</time_frame>
    <description>Lipidic profile, measured in mg/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LDL - Cholesterol</measure>
    <time_frame>It is measured on an empty stomach, change after 56 days of consumption.</time_frame>
    <description>Lipidic profile, measured in mg/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HDL - Cholesterol</measure>
    <time_frame>It is measured on an empty stomach, change after 56 days of consumption.</time_frame>
    <description>Lipidic profile, measured in mg/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>It is measured on an empty stomach, change after 56 days of consumption.</time_frame>
    <description>Lipidic profile, measured in mg/dl</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing a change of blood pressure</measure>
    <time_frame>Blood pressure measurements will be taken with a Holter monitor on two separate occasions and for 24 hours each day. Measurements were made at baseline and after 56 days of product consumption. Systolic and diastolic blood pressure will be measured</time_frame>
    <description>blood pressure is measured with a holter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>Glycidic analysis, measured in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycosylated hemoglobin (HBA1c)</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>Glycidic analysis, measured in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>malondialdehyde (MDA)</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>oxidative damage, measured in ng/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidized LDL</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>oxidative damage, measured in pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superoxide Dismutase (SOD)</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>antioxidant defense, measured in pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin-6 (IL-6)</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>Inflammation, measured in pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proteins C Reactive (PCR)</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>Inflammation, measured in mg/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>Bioimpedance, in Kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle mass</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>Bioimpedance, in Kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>Bioimpedance, in Kg/m2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of fat mass</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>Bioimpedance, in %.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Control of dietary intake</measure>
    <time_frame>A nutritional registry will be carried out. The nutritional intake of three days in two periods will be collected. One record at the beginning and another at the end, that is, six days.</time_frame>
    <description>Diet source</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Questionnaire</measure>
    <time_frame>It is measured before and after the consumption time (56 days).</time_frame>
    <description>Measured with the questionnaire Global Questionnaire on Physical Activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver safety variables</measure>
    <time_frame>It is measured on an empty stomach, before and after the consumption time (56 days).</time_frame>
    <description>It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Cardiovascular Risk</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consumption of antioxidant boiled ham, 100 grams daily to consume during the day.&#xD;
Consumption time: 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Consumption of extra boiled ham, 100 grams daily to consume during the day. Consumption time: 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary supplement consumption</intervention_name>
    <description>The consumption time was 56 days. Consumed 100 grams daily to consume during the day.</description>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_label>control group Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects of both sexes (men or women) between 30 and 75 years of age, Caucasian.&#xD;
&#xD;
          -  Present body mass index between 20 and 32 Kg / m2.&#xD;
&#xD;
          -  Presenting fasting serum LDL-cholesterol levels equal to or greater than 110 mg / dL&#xD;
             or total serum cholesterol equal to or greater than 180 mg / dL.&#xD;
&#xD;
          -  Volunteers capable of understanding the clinical study and willing to grant written&#xD;
             informed consent and to comply with study procedures and requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune,&#xD;
             inflammatory).&#xD;
&#xD;
          -  Subjects who have suffered an ischemic-vascular event in the last months.&#xD;
&#xD;
          -  Subjects in medication and / or nutraceutical treatment for hypertension, diabetes or&#xD;
             hyperlipidemia (ex: statins).&#xD;
&#xD;
          -  Subjects in treatment with drugs that due to their narrow therapeutic margin require&#xD;
             monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...).&#xD;
&#xD;
          -  Subjects in treatment that affects body weight or appetite.&#xD;
&#xD;
          -  History of allergic hypersensitivity or poor tolerance to any component of the&#xD;
             products under study.&#xD;
&#xD;
          -  Subjects who are carrying out or intend to carry out any type of diet, low-calorie or&#xD;
             not, during the study.&#xD;
&#xD;
          -  Subjects who have donated a minimum of 0.5L of blood in the last month Vegetarian&#xD;
             subjects.&#xD;
&#xD;
          -  Subjects who have ingested omega 3 and / or 6 supplements in the last three months,&#xD;
             (eg, fish oil, evening primrose oil, krill oil, or algae oil).&#xD;
&#xD;
          -  Subjects under treatment with niacin or fibrates.&#xD;
&#xD;
          -  Those subjects with alcohol abuse, or with excessive alcohol consumption (&gt; 3 glasses&#xD;
             of wine or beer / day) were excluded.&#xD;
&#xD;
          -  Patients undergoing major surgery in the last 3 months.&#xD;
&#xD;
          -  Smoking subjects or not, but in any case who have changed their nicotinic habits&#xD;
             during their participation in the study.&#xD;
&#xD;
          -  Participation in another clinical trial in the three months prior to the study.&#xD;
&#xD;
          -  Lack of will or inability to comply with clinical trial procedures.&#xD;
&#xD;
          -  Subjects whose condition did not make them eligible for the study according to the&#xD;
             researcher's criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Catholic University of Murcia</name>
      <address>
        <city>Murcia</city>
        <zip>30107</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Francisco Javier López Román</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04506749
org study id: UCAMCFE-00015
nct id: NCT04506749
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Single-blind, double-blind, controlled, randomized clinical trial of two parallel branches
      depending on the product consumed (experimental product and placebo product) and
      single-center with the objective of evaluating the effect of the investigational product on
      cardiovascular risk reduction.
Subjects who meet the selection criteria will make a total of two visits to the research
      laboratory and will carry out the tests established in the protocol. Subsequently, a
      statistical analysis will be performed with the variables measured in the study to obtain
      results.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Total Cholesterol
time frame: It is measured on an empty stomach, change after 56 days of consumption.
description: Lipidic profile, measured in mg/dl
measure: LDL - Cholesterol
time frame: It is measured on an empty stomach, change after 56 days of consumption.
description: Lipidic profile, measured in mg/dl
measure: HDL - Cholesterol
time frame: It is measured on an empty stomach, change after 56 days of consumption.
description: Lipidic profile, measured in mg/dl
measure: Triglycerides
time frame: It is measured on an empty stomach, change after 56 days of consumption.
description: Lipidic profile, measured in mg/dl
measure: Assessing a change of blood pressure
time frame: Blood pressure measurements will be taken with a Holter monitor on two separate occasions and for 24 hours each day. Measurements were made at baseline and after 56 days of product consumption. Systolic and diastolic blood pressure will be measured
description: blood pressure is measured with a holter
measure: Blood glucose
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: Glycidic analysis, measured in mg/dL
measure: Glycosylated hemoglobin (HBA1c)
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: Glycidic analysis, measured in %
measure: malondialdehyde (MDA)
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: oxidative damage, measured in ng/ml
measure: Oxidized LDL
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: oxidative damage, measured in pg/mL
measure: Superoxide Dismutase (SOD)
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: antioxidant defense, measured in pg/mL
measure: Interleukin-6 (IL-6)
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: Inflammation, measured in pg/mL
measure: Proteins C Reactive (PCR)
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: Inflammation, measured in mg/l
measure: Fat mass
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: Bioimpedance, in Kg.
measure: Muscle mass
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: Bioimpedance, in Kg.
measure: Body mass index
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: Bioimpedance, in Kg/m2.
measure: Percentage of fat mass
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: Bioimpedance, in %.
measure: Control of dietary intake
time frame: A nutritional registry will be carried out. The nutritional intake of three days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
description: Diet source
measure: Physical Activity Questionnaire
time frame: It is measured before and after the consumption time (56 days).
description: Measured with the questionnaire Global Questionnaire on Physical Activity
measure: Liver safety variables
time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
description: It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
arm group label: Experimental group
arm group type: Experimental
description: Consumption of antioxidant boiled ham, 100 grams daily to consume during the day.
Consumption time: 8 weeks.
arm group label: control group Placebo
arm group type: Placebo Comparator
description: Consumption of extra boiled ham, 100 grams daily to consume during the day. Consumption time: 8 weeks.
intervention type: Dietary Supplement
intervention name: Dietary supplement consumption
description: The consumption time was 56 days. Consumed 100 grams daily to consume during the day.
arm group label: Experimental group
arm group label: control group Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Francisco Javier López Román
investigator title: Principal Investigator
sharing ipd: No