<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/NCT02221973</url>
  </required_header>
  <id_info>
    <org_study_id>12.03.NRC</org_study_id>
    <nct_id>NCT02221973</nct_id>
  </id_info>
  <brief_title>Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects</brief_title>
  <acronym>Lipidown</acronym>
  <official_title>Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary Dyslipidemia Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids&#xD;
      reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial:&#xD;
      demonstrate potential to reduce total blood cholesterol more than 10% and/or total&#xD;
      triglycerides more than 15%, as required by State food and drug administration (SFDA)&#xD;
      regulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed clinical trial is a pilot randomized, double-blind, placebo controlled,&#xD;
      parallel, multicenter study with three treatment groups.&#xD;
&#xD;
      The total number of 75 subjects should be enrolled to provide for a 20% dropout rate.&#xD;
&#xD;
      Subjects will be randomized into one of the following 3 groups:&#xD;
&#xD;
        -  milk without sterols and hawthorn powder&#xD;
&#xD;
        -  milk with 1.2g/d sterols and 8g/d hawthorn powder&#xD;
&#xD;
        -  milk with 1.8g/d sterols and 8g/d hawthorn powder&#xD;
&#xD;
      The trial population will consist of female or male volunteers aged 18 - 65 years of age with&#xD;
      primary mild to moderate hyperlipidemia documented by a serum cholesterol of 5.18-6.21mmol/L&#xD;
      AND serum Triglycerides (TG): 1.7-5.65mmol/L , for at least 1 time tested by central&#xD;
      laboratory in the past 2 weeks prior to recruitment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>serum concentration of Total Cholesterol (TC),</measure>
    <time_frame>after 7 weeks of treatment.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc.</measure>
    <time_frame>at 4 and 7 weeks of treatment</time_frame>
    <description>other lipid and lipoprotein parameters in serum samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>biomarkers of lipid oxidation and inflammation</measure>
    <time_frame>after 7 weeks of treatment</time_frame>
    <description>biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>phytosterol metabolism parameters</measure>
    <time_frame>after 7 weeks of treatment</time_frame>
    <description>phytosterol metabolism parameters in fecal samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>predictive marker for cardiovascular disease</measure>
    <time_frame>after 7 weeks of treatment</time_frame>
    <description>assess predictive marker for cardiovascular disease by non-invasive vascular screening device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety parameters</measure>
    <time_frame>after 7 weeks of treatment</time_frame>
    <description>safety parameters</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Primary Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>milk with 1.2g/d sterols and 8g/d hawthorn powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>milk with 1.8g/d sterols and 8g/d hawthorn powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>milk without sterols and hawthorn powder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>sterols and hawthorn powder</intervention_name>
    <description>there are two dose level of sterols (1.2g/d; 1/8g/d)</description>
    <arm_group_label>milk with 1.2g/d sterols and 8g/d hawthorn powder</arm_group_label>
    <arm_group_label>milk with 1.8g/d sterols and 8g/d hawthorn powder</arm_group_label>
    <arm_group_label>milk without sterols and hawthorn powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese male or female 18 to 65 years old (inclusive). Fasting Serum TC:&#xD;
             5.18-6.21mmol/L (equals to 200-241 mg/dl) AND Serum TG: 1.7-5.65mmol/L (equals to 150-&#xD;
             500 mg/dl) for at least 1 time tested by central laboratory in the past 2 weeks prior&#xD;
             to recruitment.&#xD;
&#xD;
          -  Primary dyslipidemia.&#xD;
&#xD;
          -  The subject demonstrates an understanding of the given information and ability to&#xD;
             record the requested data.&#xD;
&#xD;
          -  Having obtained his/her informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI above 32 kg/m2 ( morbid obesity).&#xD;
&#xD;
          -  Pregnant or lactating women or intent to get pregnant.&#xD;
&#xD;
          -  Menopause women on hormonal replacement therapy.&#xD;
&#xD;
          -  Familial hyperlipidemia.&#xD;
&#xD;
          -  Identified food allergy to dairy product or lactose intolerance.&#xD;
&#xD;
          -  Severe diseases in heart, liver, kidney or hematopoietic system before admission.&#xD;
&#xD;
          -  History of angina, myocardial infarction, coronary artery bypass, heart failure or&#xD;
             other cardiovascular instability during the last 6 months.&#xD;
&#xD;
          -  History of diabetes, GI, renal, pulmonary, hepatic and biliary, hypothyroidism, mental&#xD;
             disease no self-control capacity or no articulate.&#xD;
&#xD;
          -  Subject who are currently taking drugs that interfere with lipid profiles, including&#xD;
             but not limited to statin, nicotinic acid, bile acid sequestrant, fibric acids,&#xD;
             policosanol tablets.&#xD;
&#xD;
          -  Subject who has received any anti-hyperlipidemia medication in the past 4 weeks.&#xD;
&#xD;
          -  Subject who regularly takes supplements with the function of lipid reduction in the&#xD;
             past 3 months or will take during the study (e.g. plant sterols, omega-3 fish oil,&#xD;
             beta-glucan, nut-rich diet, soy protein, soluble oat fiber, red yeast rice or other&#xD;
             cholesterol reducing functional ingredients).&#xD;
&#xD;
          -  In-patient hyperlipidemia subjects.&#xD;
&#xD;
          -  Alcohol &gt; 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day.&#xD;
&#xD;
          -  Subject who cannot be expected to comply with the study procedures.&#xD;
&#xD;
          -  Subject who is currently participating or having participated in another clinical&#xD;
             trial during the last 4 weeks prior to the beginning of this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Anzhen Hospital, Capital University of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chao Yang 2nd Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chui Yang Liu Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>November 11, 2015</last_update_submitted>
  <last_update_submitted_qc>November 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 13, 2015</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>Dyslipidemias</mesh_term>
  </condition_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/NCT02221973
org study id: 12.03.NRC
nct id: NCT02221973
lead sponsor: 
has dmc: No
The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids
      reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial:
      demonstrate potential to reduce total blood cholesterol more than 10% and/or total
      triglycerides more than 15%, as required by State food and drug administration (SFDA)
      regulation.
The proposed clinical trial is a pilot randomized, double-blind, placebo controlled,
      parallel, multicenter study with three treatment groups.

      The total number of 75 subjects should be enrolled to provide for a 20% dropout rate.

      Subjects will be randomized into one of the following 3 groups:

        -  milk without sterols and hawthorn powder

        -  milk with 1.2g/d sterols and 8g/d hawthorn powder

        -  milk with 1.8g/d sterols and 8g/d hawthorn powder

      The trial population will consist of female or male volunteers aged 18 - 65 years of age with
      primary mild to moderate hyperlipidemia documented by a serum cholesterol of 5.18-6.21mmol/L
      AND serum Triglycerides (TG): 1.7-5.65mmol/L , for at least 1 time tested by central
      laboratory in the past 2 weeks prior to recruitment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: serum concentration of Total Cholesterol (TC),
time frame: after 7 weeks of treatment.
measure: other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc.
time frame: at 4 and 7 weeks of treatment
description: other lipid and lipoprotein parameters in serum samples
measure: biomarkers of lipid oxidation and inflammation
time frame: after 7 weeks of treatment
description: biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples
measure: phytosterol metabolism parameters
time frame: after 7 weeks of treatment
description: phytosterol metabolism parameters in fecal samples
measure: predictive marker for cardiovascular disease
time frame: after 7 weeks of treatment
description: assess predictive marker for cardiovascular disease by non-invasive vascular screening device
measure: safety parameters
time frame: after 7 weeks of treatment
description: safety parameters
arm group label: milk with 1.2g/d sterols and 8g/d hawthorn powder
arm group type: Experimental
arm group label: milk with 1.8g/d sterols and 8g/d hawthorn powder
arm group type: Experimental
arm group label: milk without sterols and hawthorn powder
arm group type: Active Comparator
intervention type: Dietary Supplement
intervention name: sterols and hawthorn powder
description: there are two dose level of sterols (1.2g/d; 1/8g/d)
arm group label: milk with 1.2g/d sterols and 8g/d hawthorn powder
arm group label: milk with 1.8g/d sterols and 8g/d hawthorn powder
arm group label: milk without sterols and hawthorn powder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Dyslipidemias