<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/NCT02198703</url>
  </required_header>
  <id_info>
    <org_study_id>AB-Life study #3</org_study_id>
    <nct_id>NCT02198703</nct_id>
  </id_info>
  <brief_title>A Trial to Evaluate the Efficacy of AB-Life Probiotic Product on LDL-Cholesterol Reduction in Moderate Hypercholesterolemia</brief_title>
  <official_title>RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL FOR EVALUATING THE EFFICACY OF AB-LIFE PROBIOTIC PRODUCT ON THE LDL-CHOLESTEROL REDUCTION IN THE MODERATE HYPERCHOLESTEROLEMIA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AB Biotics, SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AB Biotics, SA</source>
  <brief_summary>
    <textblock>
      This study aims to demonstrate the effect of the chronic consumption of AB-Life probiotic&#xD;
      blend on blood LDL cholesterol level in volunteers with moderate hypercholesterolemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the fasting blood LDL cholesterol concentration</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood total cholesterol concentration</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood total cholesterol concentration</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood LDLc concentration</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood HDLc concentration</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood HDLc concentration</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood ratio total cholesterol / HDLc concentrations</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood ratio total cholesterol / HDLc concentrations</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood ratio LDLc / HDLc concentrations</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood ratio LDLc / HDLc concentrations</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood triglycerides concentration</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood triglycerides concentration</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood Apo A1 concentration</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood Apo A1 concentration</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood Apo B100 concentration</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood Apo B100 concentration</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood insulin concentration</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood insulin concentration</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood glucose concentration</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood glucose concentration</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood acetate concentration</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood propionate concentration</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood acetate / propionate concentrations</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SCORE - European Low Risk Chart of fatal cardiovascular disease</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SCORE - European Low Risk Chart of fatal cardiovascular disease</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood hsCRP concentration</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete blood count</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Alkaline Phosphatase</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Alanine Amino Transferase</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Aspartate Amino Transferase</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Gamma Glutamyl Transpeptidase</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood total bilirubin</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood urea</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood creatinine</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Score</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total energy intake</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of energy intake from fat</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary fiber intake</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saturated Fatty Acids intake</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Fasting blood PCSK9 concentration</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting blood FGF-19 concentration</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting blood LDLox concentration</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting blood fibrinogen concentration</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting blood biliary acids concentrations</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fecal concentrations of neutral sterol including cholesterol and its secondary metabolites</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fecal concentrations of phytosterols</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fecal concentrations of volatil fatty acids</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fecal concentrations of branched chain fatty acids</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fecal concentrations of biliary acids</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fecal concentrations of AB-Life probiotic strains</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fecal concentration of calprotectin</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting blood sodium concentration</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting blood potassium concentration</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting blood bicarbonates concentration</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting blood calcium concentration</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting blood inorganic phosphate concentration</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urine aspect</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urine color</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary density level</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary bilirubin level</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary urobilirubinogen level</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary protein level</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary glucose level</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary ketones level</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary nitrites level</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urine sediment</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urine osmolality</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urine pH</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary red cells level</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary white cells level</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Moderate Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>AB-Life</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 capsule of AB-Life daily during 12 weeks consumed immediately before, after or during the breakfast. The daily dose corresponds to the intake of 1.8E+10 CFU. According to the product's stability and the duration of the experiment, all participants receive at least 1.2E+09 CFU/capsule/day by the end of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 capsule of placebo daily during 12 weeks consumed immediately before, after or during the breakfast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotics bacterial strains</intervention_name>
    <arm_group_label>AB-Life</arm_group_label>
    <other_name>AB-Life</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>AB-life</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be eligible to the study, male and female volunteers will have to fulfill the following&#xD;
        criteria (assessment based on the medical examination performed at V1 with a checking at&#xD;
        V3):&#xD;
&#xD;
          -  Age between 18 and 65 years (limits included).&#xD;
&#xD;
          -  BMI between 18,5 and 30 kg/m² ((limits excluded).&#xD;
&#xD;
          -  For women : Non menopausal with reliable contraception since at least two cycles&#xD;
             before the beginning of the study and agreeing to keep it during the entire duration&#xD;
             of the study (condom alone without spermicide gel and oestrogenic contraceptive&#xD;
             excluded) or menopausal without oestrogenic replacement therapy.&#xD;
&#xD;
          -  Good general and mental health with in the opinion of the investigator: no clinically&#xD;
             significant and relevant abnormalities of medical history or physical examination.&#xD;
&#xD;
          -  Able and willing to participate to the study by complying with the protocol procedures&#xD;
             as evidenced by his dated and signed informed consent form.&#xD;
&#xD;
          -  Affiliated with a social security scheme.&#xD;
&#xD;
          -  Agree to be registered on the volunteers in biomedical research file.&#xD;
&#xD;
        After V1 biological analysis the subjects will be eligible to the visit V2 on the following&#xD;
        criteria:&#xD;
&#xD;
        - Fasting plasma LDLc level (Friedewald estimation method) between 1,3 and 1,89 g/L (3,35 -&#xD;
        4,92 mmol/L, limits included with ± 2% tolerated around).&#xD;
&#xD;
        After V2 biological analysis the subjects will be eligible to the study on the following&#xD;
        criteria:&#xD;
&#xD;
        - Fasting plasma LDLc level (Friedewald estimation method) between 1,3 and 1,89 g/L (3,35 -&#xD;
        4,92 mmol/L, limits included with ± 2% tolerated around).&#xD;
&#xD;
        A re-screening can occur from 2 months after the exit of study for failure to comply with&#xD;
        the one or more of the eligibility criteria listed above.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Volunteers with the following criteria will be considered as non eligible to the study&#xD;
        (assessment based on the medical examination performed at V1 with a checking at V3):&#xD;
&#xD;
          -  Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble&#xD;
             or other chronic severe disease.&#xD;
&#xD;
          -  Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or&#xD;
             biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other&#xD;
             chronic respiratory trouble, etc.) or gastrointestinal disorders found to be&#xD;
             inconsistent with the conduct of the study by the investigator (e.g. celiac disease).&#xD;
&#xD;
          -  With a history of ischemic cardiovascular event or, during the previous 6 months a&#xD;
             surgical procedure.&#xD;
&#xD;
          -  With a known or suspected food allergy or intolerance or hypersensitivity to any of&#xD;
             the study products' ingredient.&#xD;
&#xD;
          -  Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and&#xD;
             diastolic blood pressure ≥ 100 mmHg).&#xD;
&#xD;
          -  Pregnant or lactating women or intending to become pregnant within 5 months ahead.&#xD;
&#xD;
          -  Under lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid&#xD;
             sequestrants, niacin, etc.) or stopped less than 4 months before the randomization.&#xD;
&#xD;
          -  Under medication which could affect blood lipid parameters (e.g. long-term&#xD;
             corticosteroid systemic drug, systemic antibodies, androgens or phenytoin, etc.) or&#xD;
             stopped less than 1 month before the randomization (stable long-term treatment with&#xD;
             beta blocker or thiazide diuretics tolerated).&#xD;
&#xD;
          -  Regular intake of dietary supplements or &quot;functional foods&quot; which may interfere with&#xD;
             lipid absorption and/or metabolism (e.g. rich in plant stanol or sterol like PRO-ACTIV&#xD;
             or DANACOL products, red yeast rice, policosanol, omega-3 fatty acids like fish oils,&#xD;
             ST HUBERT OMEGA 3 or PRIMEVERE products, soya protein, oat fiber like QUAKER OATS,&#xD;
             psyllium, chitosan, guar gum, inulin, etc.) or stopped less than 3 months before the&#xD;
             randomization.&#xD;
&#xD;
          -  Under treatment which could disturb microbiota balance or stopped in a too short&#xD;
             period before the randomization (e.g. less than one month for laxatives, less than 6&#xD;
             weeks for antibiotics).&#xD;
&#xD;
          -  Regular intake of dietary supplements or &quot;functional foods&quot; containing prebiotics,&#xD;
             probiotics or symbiotics (e.g. BION 3, LACTIBIANE, ACTIMEL, ACTIVIA, etc.) or stopped&#xD;
             less than 1 month before the randomization.&#xD;
&#xD;
          -  Under treatment or dietary supplement which could significantly affect parameter(s)&#xD;
             followed during the study according to the investigator or stopped in a too short&#xD;
             period before the randomization.&#xD;
&#xD;
          -  With significant change in food habits or in physical activity in the 3 months before&#xD;
             randomization or not agreeing to keep them unchanged throughout the study.&#xD;
&#xD;
          -  With reported body weight variation &gt; 5% in the 3 months prior the randomization or&#xD;
             with a hyper or hypocaloric diet planned in the next 5 months.&#xD;
&#xD;
          -  With a personal history of anorexia nervosa, bulimia or significant eating disorders&#xD;
             according to the investigator.&#xD;
&#xD;
          -  Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2&#xD;
             standard drinks daily for women or not agreeing to keep his alcohol consumption habits&#xD;
             unchanged throughout the study.&#xD;
&#xD;
          -  Smoking more than 10 cigarettes daily or not agreeing to keep his smoking habits&#xD;
             unchanged throughout the study.&#xD;
&#xD;
          -  Recent history of chronic alcohol or drug abuse (in the last 2 years).&#xD;
&#xD;
          -  Having a lifestyle deemed incompatible with the study according to the investigator&#xD;
             including high level physical activity (defined as more than 10 hours of significant&#xD;
             physical activity a week, walking excluded).&#xD;
&#xD;
          -  Who made a blood donation in the 3 months before the randomization or intending to&#xD;
             make it within 4 months ahead.&#xD;
&#xD;
          -  Taking part in another clinical trial or being in the exclusion period of a previous&#xD;
             clinical trial.&#xD;
&#xD;
          -  Having received, during the last 12 months, indemnities for clinical trial higher or&#xD;
             equal to 4500 Euros.&#xD;
&#xD;
          -  Under legal protection (guardianship, wardship) or deprived from his rights following&#xD;
             administrative or judicial decision.&#xD;
&#xD;
          -  Presenting a psychological or linguistic incapability to sign the informed consent.&#xD;
&#xD;
          -  Impossible to contact in case of emergency.&#xD;
&#xD;
        After V1 biological analysis the subjects will be considered as non eligible to the study&#xD;
        on the following criteria :&#xD;
&#xD;
          -  Fasting plasma glucose level &gt; 1,26 g/L (6,99 mmol/L).&#xD;
&#xD;
          -  Fasting plasma triglycerides &gt; 3,5 g/L (3,95 mmol/L).&#xD;
&#xD;
          -  Fasting plasma TC, HDLc or insulin with an abnormality judged as clinically&#xD;
             significant according to the investigator.&#xD;
&#xD;
        After V2 biological analysis the subjects will be considered as non eligible to the study&#xD;
        on the following criteria:&#xD;
&#xD;
          -  Fasting plasma TC, HDL or TG with an abnormality judged as clinically significant&#xD;
             according to the investigator.&#xD;
&#xD;
          -  Serum AST, ALT, GGT, ALP or bilirubin with an abnormality judged as clinically&#xD;
             significant according to the investigator.&#xD;
&#xD;
          -  Serum urea or creatinine with an abnormality judged as clinically significant&#xD;
             according to the investigator.&#xD;
&#xD;
          -  Complete blood count with clinically significant abnormality according to the&#xD;
             investigator.&#xD;
&#xD;
        Volunteers with the following criteria at the V3 will be considered as non eligible to the&#xD;
        study:&#xD;
&#xD;
          -  Capsules' consumption less than 80% of capsules during the run-in period (since V1)&#xD;
             according to the quantities returned.&#xD;
&#xD;
          -  Gastroenteritis history finished less than 2 weeks before the randomization.&#xD;
&#xD;
        The included subjects who cannot be randomized at V3 because of a too short wash out period&#xD;
        related to the non inclusion criteria E8, E10, E12 or E34 can delay their visit V3 without&#xD;
        to exceed 28 days from the visit V2.&#xD;
&#xD;
        A re-screening can occur from 2 months after the exit of study for failure to comply with&#xD;
        the one or more of the eligibility criteria listed above (except for E33 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>
  <overall_official>
    <last_name>David Gendre, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>BioFortis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ariana Salavert, Ph. D.</last_name>
    <role>Study Director</role>
    <affiliation>AB-BIOTICS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naturalpha</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biofortis</name>
      <address>
        <city>Saint-Herblain</city>
        <zip>44800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>May 29, 2018</last_update_submitted>
  <last_update_submitted_qc>May 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Probiotics</keyword>
  <keyword>AB-Life</keyword>
  <keyword>LDL-cholesterol</keyword>
  <keyword>Hypercholesterolemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</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/NCT02198703
org study id: AB-Life study #3
nct id: NCT02198703
lead sponsor: 
This study aims to demonstrate the effect of the chronic consumption of AB-Life probiotic
      blend on blood LDL cholesterol level in volunteers with moderate hypercholesterolemia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change of the fasting blood LDL cholesterol concentration
time frame: 12 weeks
measure: Change in fasting blood total cholesterol concentration
time frame: 4 weeks
measure: Change in fasting blood total cholesterol concentration
time frame: 12 weeks
measure: Change in fasting blood LDLc concentration
time frame: 4 weeks
measure: Change in fasting blood HDLc concentration
time frame: 4 weeks
measure: Change in fasting blood HDLc concentration
time frame: 12 weeks
measure: Change in fasting blood ratio total cholesterol / HDLc concentrations
time frame: 4 weeks
measure: Change in fasting blood ratio total cholesterol / HDLc concentrations
time frame: 12 weeks
measure: Change in fasting blood ratio LDLc / HDLc concentrations
time frame: 4 weeks
measure: Change in fasting blood ratio LDLc / HDLc concentrations
time frame: 12 weeks
measure: Change in fasting blood triglycerides concentration
time frame: 4 weeks
measure: Change in fasting blood triglycerides concentration
time frame: 12 weeks
measure: Change in fasting blood Apo A1 concentration
time frame: 4 weeks
measure: Change in fasting blood Apo A1 concentration
time frame: 12 weeks
measure: Change in fasting blood Apo B100 concentration
time frame: 4 weeks
measure: Change in fasting blood Apo B100 concentration
time frame: 12 weeks
measure: Change in fasting blood insulin concentration
time frame: 4 weeks
measure: Change in fasting blood insulin concentration
time frame: 12 weeks
measure: Change in fasting blood glucose concentration
time frame: 12 weeks
measure: Change in fasting blood glucose concentration
time frame: 4 weeks
measure: Change in fasting blood acetate concentration
time frame: 12 weeks
measure: Change in fasting blood propionate concentration
time frame: 12 weeks
measure: Change in fasting blood acetate / propionate concentrations
time frame: 12 weeks
measure: Change in SCORE - European Low Risk Chart of fatal cardiovascular disease
time frame: 4 weeks
measure: Change in SCORE - European Low Risk Chart of fatal cardiovascular disease
time frame: 12 weeks
measure: Change in fasting blood hsCRP concentration
time frame: 12 weeks
measure: Complete blood count
time frame: 12 weeks
measure: Blood Alkaline Phosphatase
time frame: 12 weeks
measure: Blood Alanine Amino Transferase
time frame: 12 weeks
measure: Blood Aspartate Amino Transferase
time frame: 12 weeks
measure: Blood Gamma Glutamyl Transpeptidase
time frame: 12 weeks
measure: Blood total bilirubin
time frame: 12 weeks
measure: Blood urea
time frame: 12 weeks
measure: Blood creatinine
time frame: 12 weeks
measure: Heart rate
time frame: 4 weeks
measure: Heart rate
time frame: 12 weeks
measure: Systolic Blood Pressure
time frame: 4 weeks
measure: Diastolic Blood Pressure
time frame: 4 weeks
measure: Diastolic Blood Pressure
time frame: 12 weeks
measure: Systolic Blood Pressure
time frame: 12 weeks
measure: Body weight
time frame: 4 weeks
measure: Body weight
time frame: 12 weeks
measure: Physical Activity Score
time frame: 12 weeks
measure: Total energy intake
time frame: 12 weeks
measure: Percentage of energy intake from fat
time frame: 12 weeks
measure: Dietary fiber intake
time frame: 12 weeks
measure: Saturated Fatty Acids intake
time frame: 12 weeks
measure: Fasting blood PCSK9 concentration
time frame: 12 weeks
measure: Fasting blood FGF-19 concentration
time frame: 12 weeks
measure: Fasting blood LDLox concentration
time frame: 12 weeks
measure: Fasting blood fibrinogen concentration
time frame: 12 weeks
measure: Fasting blood biliary acids concentrations
time frame: 12 weeks
measure: Fecal concentrations of neutral sterol including cholesterol and its secondary metabolites
time frame: 12 weeks
measure: Fecal concentrations of phytosterols
time frame: 12 weeks
measure: Fecal concentrations of volatil fatty acids
time frame: 12 weeks
measure: Fecal concentrations of branched chain fatty acids
time frame: 12 weeks
measure: Fecal concentrations of biliary acids
time frame: 12 weeks
measure: Fecal concentrations of AB-Life probiotic strains
time frame: 12 weeks
measure: Fecal concentration of calprotectin
time frame: 12 weeks
measure: Fasting blood sodium concentration
time frame: 12 weeks
measure: Fasting blood potassium concentration
time frame: 12 weeks
measure: Fasting blood bicarbonates concentration
time frame: 12 weeks
measure: Fasting blood calcium concentration
time frame: 12 weeks
measure: Fasting blood inorganic phosphate concentration
time frame: 12 weeks
measure: Urine aspect
time frame: 12 weeks
measure: Urine color
time frame: 12 weeks
measure: Urinary density level
time frame: 12 weeks
measure: Urinary bilirubin level
time frame: 12 weeks
measure: Urinary urobilirubinogen level
time frame: 12 weeks
measure: Urinary protein level
time frame: 12 weeks
measure: Urinary glucose level
time frame: 12 weeks
measure: Urinary ketones level
time frame: 12 weeks
measure: Urinary nitrites level
time frame: 12 weeks
measure: Urine sediment
time frame: 12 weeks
measure: Urine osmolality
time frame: 12 weeks
measure: Urine pH
time frame: 12 weeks
measure: Urinary red cells level
time frame: 12 weeks
measure: Urinary white cells level
time frame: 12 weeks
arm group label: AB-Life
arm group type: Experimental
description: 1 capsule of AB-Life daily during 12 weeks consumed immediately before, after or during the breakfast. The daily dose corresponds to the intake of 1.8E+10 CFU. According to the product's stability and the duration of the experiment, all participants receive at least 1.2E+09 CFU/capsule/day by the end of the study.
arm group label: Placebo
arm group type: Placebo Comparator
description: 1 capsule of placebo daily during 12 weeks consumed immediately before, after or during the breakfast.
intervention type: Dietary Supplement
intervention name: Probiotics bacterial strains
arm group label: AB-Life
other name: AB-Life
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
other name: AB-life
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Gendre, M.D.
role: Principal Investigator
affiliation: BioFortis
last name: Ariana Salavert, Ph. D.
role: Study Director
affiliation: AB-BIOTICS
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Hypercholesterolemia