<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/NCT02236533</url>
  </required_header>
  <id_info>
    <org_study_id>SFLAB14</org_study_id>
    <nct_id>NCT02236533</nct_id>
  </id_info>
  <brief_title>Healthy Effects of an Innovative Probiotic Pasta</brief_title>
  <acronym>SFLABPASTA</acronym>
  <official_title>Healthy Effects of an Innovative Probiotic Pasta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Parma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universita di Verona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Parma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of&#xD;
      a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus&#xD;
      coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized&#xD;
      controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidemiological evidences indicate that consumption of whole grains products is associated to&#xD;
      a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity,&#xD;
      hypertension and metabolic syndrome. In the present study a whole grain pasta was&#xD;
      supplemented with prebiotics and probiotics 'ad hoc' formulated. In detail, pasta was&#xD;
      industrially developed after the identification of particular cultivars of wheat and barley,&#xD;
      rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants.&#xD;
      Further, pasta was supplemented with spores of Bacillus coagulans, a putative probiotic&#xD;
      microorganism, belonging to Lactobacillus family. It is well demonstrated the ability of this&#xD;
      microorganism to survive to technological processes and to upper gastro-intesinal tract, in&#xD;
      order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing&#xD;
      immunological defences as well as improvements in intestinal regularity. Conversely, the&#xD;
      control pasta was made from the same cultivar of grain and by the same technological process,&#xD;
      but without any supplementation.&#xD;
&#xD;
      In this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly&#xD;
      allocated for the consumption of the two kind of pasta once a day, for 12 weeks. At the&#xD;
      beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and&#xD;
      feces for the evaluation of:&#xD;
&#xD;
        -  blood inflammation markers;&#xD;
&#xD;
        -  blood lipid and carbohydrate profile;&#xD;
&#xD;
        -  blood and urine markers of cardiovascular risk;&#xD;
&#xD;
        -  feces profile of microbiota and detection of markers for the healthiness of the gut.&#xD;
&#xD;
      In addition, volunteers filled in different questionnaires regarding their dietary habits,&#xD;
      the physical activity and the gut healthiness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">September 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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Variation of plasma lipids</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol; Measure of plasma concentrations (µg/mL) of Non Esterified Fatty Acids (NEFA), Esterified Fatty Acids (EFA) and Short Chain Fatty Acids (SCFA).&#xD;
Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation of fecal microbiota composition</measure>
    <time_frame>12 weeks</time_frame>
    <description>By FISH (colony-forming unit, CFU/g).&#xD;
Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation of antioxidant activity on fecal waters</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measure of fecal waters FRAP (µmol/L) and TEAC (µmol/L) concentrations.&#xD;
Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variation of body weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measure of body weight (kg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of serum inflammatory marker concentration</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measure of serum IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IFN-γ,TNF-α, PAI-1, Ghrelin, Leptin, Visfatin, Resistin concentrations (pg/mL).&#xD;
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of blood pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measure of blood pressure (mmHg).&#xD;
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of body circumferences</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measure of waist and hip circumferences (mm).&#xD;
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of urine antioxidant marker</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measurement of betaine in urine (mmol/L).&#xD;
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>OBESITY</condition>
  <condition>INFLAMMATION</condition>
  <condition>DYSLIPIDEMIA</condition>
  <condition>CONSTIPATION</condition>
  <arm_group>
    <arm_group_label>Control pasta</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic Whole Grain Pasta</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>whole grain pasta</intervention_name>
    <description>Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.</description>
    <arm_group_label>Control pasta</arm_group_label>
    <arm_group_label>Probiotic Whole Grain Pasta</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight / Obesity&#xD;
&#xD;
          -  Lower consumers of fruit and vegetables&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antibiotic treatment within 3 months prior the pasta feeding&#xD;
&#xD;
          -  Chronic diseases&#xD;
&#xD;
          -  Surgeries&#xD;
&#xD;
          -  Consumer of whole grain products&#xD;
&#xD;
          -  Dieting&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicoletta Pellegrini, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Parma - Department of Food Sciences</name>
      <address>
        <city>Parma</city>
        <state>PR</state>
        <zip>43124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Parma</name>
      <address>
        <city>Parma</city>
        <zip>43124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
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  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>October 30, 2018</last_update_submitted>
  <last_update_submitted_qc>October 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Parma</investigator_affiliation>
    <investigator_full_name>Nicoletta Pellegrini, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Constipation</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/NCT02236533
org study id: SFLAB14
nct id: NCT02236533
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of
      a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus
      coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized
      controlled trial.
Epidemiological evidences indicate that consumption of whole grains products is associated to
      a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity,
      hypertension and metabolic syndrome. In the present study a whole grain pasta was
      supplemented with prebiotics and probiotics 'ad hoc' formulated. In detail, pasta was
      industrially developed after the identification of particular cultivars of wheat and barley,
      rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants.
      Further, pasta was supplemented with spores of Bacillus coagulans, a putative probiotic
      microorganism, belonging to Lactobacillus family. It is well demonstrated the ability of this
      microorganism to survive to technological processes and to upper gastro-intesinal tract, in
      order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing
      immunological defences as well as improvements in intestinal regularity. Conversely, the
      control pasta was made from the same cultivar of grain and by the same technological process,
      but without any supplementation.

      In this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly
      allocated for the consumption of the two kind of pasta once a day, for 12 weeks. At the
      beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and
      feces for the evaluation of:

        -  blood inflammation markers;

        -  blood lipid and carbohydrate profile;

        -  blood and urine markers of cardiovascular risk;

        -  feces profile of microbiota and detection of markers for the healthiness of the gut.

      In addition, volunteers filled in different questionnaires regarding their dietary habits,
      the physical activity and the gut healthiness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Variation of plasma lipids
time frame: 12 weeks
description: Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol; Measure of plasma concentrations (µg/mL) of Non Esterified Fatty Acids (NEFA), Esterified Fatty Acids (EFA) and Short Chain Fatty Acids (SCFA).
Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
measure: Variation of fecal microbiota composition
time frame: 12 weeks
description: By FISH (colony-forming unit, CFU/g).
Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
measure: Variation of antioxidant activity on fecal waters
time frame: 12 weeks
description: Measure of fecal waters FRAP (µmol/L) and TEAC (µmol/L) concentrations.
Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
measure: Variation of body weight
time frame: 12 weeks
description: Measure of body weight (kg).
measure: Variation of serum inflammatory marker concentration
time frame: 12 weeks
description: Measure of serum IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IFN-γ,TNF-α, PAI-1, Ghrelin, Leptin, Visfatin, Resistin concentrations (pg/mL).
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
measure: Variation of blood pressure
time frame: 12 weeks
description: Measure of blood pressure (mmHg).
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
measure: Variation of body circumferences
time frame: 12 weeks
description: Measure of waist and hip circumferences (mm).
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
measure: Variation of urine antioxidant marker
time frame: 12 weeks
description: Measurement of betaine in urine (mmol/L).
Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered.
arm group label: Control pasta
arm group type: Placebo Comparator
description: Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks.
arm group label: Probiotic Whole Grain Pasta
arm group type: Experimental
description: Volunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks.
intervention type: Dietary Supplement
intervention name: whole grain pasta
description: Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.
arm group label: Control pasta
arm group label: Probiotic Whole Grain Pasta
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nicoletta Pellegrini, Professor
role: Principal Investigator
affiliation: University of Parma
facility: 
facility: 
country: Italy
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responsible party type: Principal Investigator
investigator affiliation: University of Parma
investigator full name: Nicoletta Pellegrini, PhD
investigator title: Associate Professor
mesh term: Dyslipidemias
mesh term: Inflammation
mesh term: Constipation