<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/NCT03263104</url>
  </required_header>
  <id_info>
    <org_study_id>UREC 15/06</org_study_id>
    <nct_id>NCT03263104</nct_id>
  </id_info>
  <brief_title>The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum in Hypercholesterolaemic Adults</brief_title>
  <acronym>PROBIOCHOL</acronym>
  <official_title>Single-centre, Prospective, Randomised, Placebo-controlled, Parallel-group Design to Determine the Cholesterol-lowering Efficacy of Lactobacillus Plantarum ECGC 13110402 in Normal to Mildly Hypercholesterolaemic Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roehampton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roehampton</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>
      Coronary heart disease (CHD) is one of the major causes of death and disability in&#xD;
      industrialised countries. Results from several epidemiological and clinical studies indicate&#xD;
      a positive correlation between elevated total serum cholesterol levels, mainly reflecting the&#xD;
      LDL-cholesterol fraction, and risk of CHD. It is thought that a reduction in total plasma&#xD;
      cholesterol levels in populations suffering from primary hypercholesterolemia (elevated&#xD;
      cholesterol) can lower the incidence of coronary thrombosis. Currently, therefore there is&#xD;
      extensive interest in the management of serum cholesterol and other blood lipids. Diet is&#xD;
      viewed as a major influencing factor that can reduce levels. This is largely driven by the&#xD;
      expense of drug therapy, the large numbers of individuals affected and unwanted side effects&#xD;
      of such treatments. Dietary strategies for prevention of CHD implicate adherence to a&#xD;
      low-fat/low-saturated fat diet. Although such diets may present an effective approach, they&#xD;
      are difficult to maintain on a long-term basis and efficacy diminishes over time. As such,&#xD;
      new approaches towards identification of other dietary means of reducing blood cholesterol&#xD;
      levels have been evaluated. These include, among others, the use of probiotics. Probiotics&#xD;
      are 'live microbial feed supplements that offer a benefit to health'. They are marketed as&#xD;
      health or functional foods whereby they are ingested for their purported positive advantages&#xD;
      in the digestive tract and/or systemic areas like the liver, vagina or bloodstream. The main&#xD;
      goal of the study was to test whether probiotics can directly degrade cholesterol as well as&#xD;
      produce metabolites that interfere with its synthesis in the liver. The effect may also be&#xD;
      partially ascribed to an enzymatic deconjugation of bile acids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this human volunteer study was to establish tolerance, and the extent of the&#xD;
      cholesterol lowering potential of Lactobacillus plantarum ECGC 13110402 in 49, healthy,&#xD;
      normal to mildly hypercholesterolaemic adults (30-65 years old).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">June 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>
    <intervention_model_description>Single-centre, prospective, randomised, placebo-controlled, parallel-group design to determine the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double Blind (Participant, Investigator,Outcomes Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Modulation of the blood lipids by L. plantarum ECGC 13110402 The modulation of the blood lipids by L. plantarum ECGC 13110402</measure>
    <time_frame>Changes from baseline to 6-12 week treatment period with the probiotic</time_frame>
    <description>Effects of the probiotic on TC, LDL-C, HDL-C and TAG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modulation of immune function by L. plantarum ECGC 13110402</measure>
    <time_frame>Changes from baseline to 6-12 week treatment period with the probiotic</time_frame>
    <description>Blood samples analysis to assess changes in cytokines production Blood samples analysis to assess changes in cytokines production Blood samples analysis to assess changes in cytokines production</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Digestive symptoms</measure>
    <time_frame>Changes from baseline to 6-12 week treatment period with the probiotic</time_frame>
    <description>Bristol diary form Bristol diary form</description>
  </other_outcome>
  <other_outcome>
    <measure>Microbiota changes</measure>
    <time_frame>Changes from baseline to 6-12 week treatment period with the probiotic</time_frame>
    <description>DNA profiling from faeces</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Lactobacillus plantarum ECGC 13110402</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lactobacillus plantarum ECGC 13110402 equivalent to 2x10^9 CFU (0.1 g) with the addition of filling carrier (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed twice daily, before breakfast and dinner with 250mL of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin (an oligosaccharide without prebiotic effect) (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed twice daily, before breakfast and dinner with 250mL of water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactobacillus plantarum ECGC 13110402</intervention_name>
    <description>Lactobacillus plantarum ECGC 13110402</description>
    <arm_group_label>Lactobacillus plantarum ECGC 13110402</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <arm_group_label>Maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged between 18 and 50 years of age.&#xD;
&#xD;
          -  in good general health, defined as no comorbidities requiring regular&#xD;
&#xD;
          -  medical follow up&#xD;
&#xD;
          -  ability to communicate well with the investigator and to comply with the&#xD;
&#xD;
          -  requirements of the entire study&#xD;
&#xD;
          -  BMI 18.5 to 29.9 kg/m2&#xD;
&#xD;
          -  total cholesterol (TC) between 200 and 300 mg/dl (5.16 and 7.64 mmol/L).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or evidence of organic disease of the gastrointestinal tract; such as tumour,&#xD;
             irritable bowel syndrome, etc., within the previous 5 years&#xD;
&#xD;
          -  Consumed probiotic or prebiotic preparations on a regular basis (at least 3&#xD;
&#xD;
          -  times per week) in the last 2 weeks and during the trial period&#xD;
&#xD;
          -  Former participation in another study involving prebiotic or probiotic&#xD;
&#xD;
          -  preparations or investigational drugs within the previous 6 months, or&#xD;
&#xD;
          -  intention to use such drugs during the course of the study&#xD;
&#xD;
          -  high blood cholesterol or use of cholesterol lowering drugs&#xD;
&#xD;
          -  Undergone surgical resection of any part of the bowel&#xD;
&#xD;
          -  History of malignancy within the previous 5 years (with exception of well-&#xD;
&#xD;
          -  treated basal cell carcinoma or in situ cervical carcinoma).&#xD;
&#xD;
          -  Currently prescribed immunosuppressive drugs&#xD;
&#xD;
          -  Intention to use regularly other medication which affects gastrointestinal&#xD;
&#xD;
          -  motility and/or perception&#xD;
&#xD;
          -  Current or recent history (within 12 months) of significant drug or alcohol&#xD;
&#xD;
          -  abuse or dependence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glenn R Gibson</last_name>
    <role>Study Director</role>
    <affiliation>The University of Reading</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roehampton</investigator_affiliation>
    <investigator_full_name>DR ADELE COSTABILE</investigator_full_name>
    <investigator_title>Health Sciences Research Centre, Life Science Department</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/NCT03263104
org study id: UREC 15/06
nct id: NCT03263104
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Coronary heart disease (CHD) is one of the major causes of death and disability in
      industrialised countries. Results from several epidemiological and clinical studies indicate
      a positive correlation between elevated total serum cholesterol levels, mainly reflecting the
      LDL-cholesterol fraction, and risk of CHD. It is thought that a reduction in total plasma
      cholesterol levels in populations suffering from primary hypercholesterolemia (elevated
      cholesterol) can lower the incidence of coronary thrombosis. Currently, therefore there is
      extensive interest in the management of serum cholesterol and other blood lipids. Diet is
      viewed as a major influencing factor that can reduce levels. This is largely driven by the
      expense of drug therapy, the large numbers of individuals affected and unwanted side effects
      of such treatments. Dietary strategies for prevention of CHD implicate adherence to a
      low-fat/low-saturated fat diet. Although such diets may present an effective approach, they
      are difficult to maintain on a long-term basis and efficacy diminishes over time. As such,
      new approaches towards identification of other dietary means of reducing blood cholesterol
      levels have been evaluated. These include, among others, the use of probiotics. Probiotics
      are 'live microbial feed supplements that offer a benefit to health'. They are marketed as
      health or functional foods whereby they are ingested for their purported positive advantages
      in the digestive tract and/or systemic areas like the liver, vagina or bloodstream. The main
      goal of the study was to test whether probiotics can directly degrade cholesterol as well as
      produce metabolites that interfere with its synthesis in the liver. The effect may also be
      partially ascribed to an enzymatic deconjugation of bile acids.
The aim of this human volunteer study was to establish tolerance, and the extent of the
      cholesterol lowering potential of Lactobacillus plantarum ECGC 13110402 in 49, healthy,
      normal to mildly hypercholesterolaemic adults (30-65 years old).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single-centre, prospective, randomised, placebo-controlled, parallel-group design to determine the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Double Blind (Participant, Investigator,Outcomes Assessor)
measure: Modulation of the blood lipids by L. plantarum ECGC 13110402 The modulation of the blood lipids by L. plantarum ECGC 13110402
time frame: Changes from baseline to 6-12 week treatment period with the probiotic
description: Effects of the probiotic on TC, LDL-C, HDL-C and TAG
measure: Modulation of immune function by L. plantarum ECGC 13110402
time frame: Changes from baseline to 6-12 week treatment period with the probiotic
description: Blood samples analysis to assess changes in cytokines production Blood samples analysis to assess changes in cytokines production Blood samples analysis to assess changes in cytokines production
measure: Digestive symptoms
time frame: Changes from baseline to 6-12 week treatment period with the probiotic
description: Bristol diary form Bristol diary form
measure: Microbiota changes
time frame: Changes from baseline to 6-12 week treatment period with the probiotic
description: DNA profiling from faeces
arm group label: Lactobacillus plantarum ECGC 13110402
arm group type: Experimental
description: Lactobacillus plantarum ECGC 13110402 equivalent to 2x10^9 CFU (0.1 g) with the addition of filling carrier (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed twice daily, before breakfast and dinner with 250mL of water.
arm group label: Maltodextrin
arm group type: Placebo Comparator
description: Maltodextrin (an oligosaccharide without prebiotic effect) (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed twice daily, before breakfast and dinner with 250mL of water.
intervention type: Dietary Supplement
intervention name: Lactobacillus plantarum ECGC 13110402
description: Lactobacillus plantarum ECGC 13110402
arm group label: Lactobacillus plantarum ECGC 13110402
intervention type: Dietary Supplement
intervention name: Maltodextrin
arm group label: Maltodextrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Glenn R Gibson
role: Study Director
affiliation: The University of Reading
responsible party type: Principal Investigator
investigator affiliation: University of Roehampton
investigator full name: DR ADELE COSTABILE
investigator title: Health Sciences Research Centre, Life Science Department
sharing ipd: No