xml: <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/NCT06015867</url>
    </required_header>
    <id_info>
      <org_study_id>S64824 - B3222020000339</org_study_id>
      <nct_id>NCT06015867</nct_id>
    </id_info>
    <brief_title>Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake</brief_title>
    <acronym>SPAR</acronym>
    <official_title>Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake at the Subsequent Meal (SPAR Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>KU Leuven</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>KU Leuven</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        During this project the effect of yeast bread and sourdough breads consumption on satiety,&#xD;
        energy intake at subsequent meal and postprandial metabolic responses, will be investigated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary aim of this study will be to evaluate the impact of an alternative starter&#xD;
        culture that produces high levels of lactic acid on appetite regulation (subjective satiety&#xD;
        and energy intake at the subsequent meal). The second aim will be to identify mechanistic&#xD;
        parameters that may explain the observed effects, including glycaemic and insulin response,&#xD;
        and gastric emptying rate. In addition, habitual physical activity levels, and mood and&#xD;
        stress levels of the subjects will be evaluated as potential covariates of appetite&#xD;
        regulation.&#xD;
  &#xD;
        It is hypothesized that:&#xD;
  &#xD;
        Sourdough breads fermented with the alternative starter culture that produce high&#xD;
        concentrations of lactic acid will reduce glucose response via lower starch digestibility&#xD;
        and/or slower gastric emptying rate. The reduced glycaemic response will lead to higher&#xD;
        satiety and lower energy intake at the subsequent meal (more than 10%).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Appetite measurements</measure>
      <time_frame>During test day 1 (up to 4 hours)</time_frame>
      <description>Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).&#xD;
  Measurements will be taken: before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Appetite measurements</measure>
      <time_frame>During test day 2 (up to 4 hours)</time_frame>
      <description>Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).&#xD;
  Measurements will be taken: before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Food intake at subsequent meal</measure>
      <time_frame>During test day 1 (240 minutes after ingestion of breakfast)</time_frame>
      <description>Weighted amounts of ad-libitum food offered minus the weighted leftovers</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Food intake at subsequent meal</measure>
      <time_frame>During test day 2 (240 minutes after ingestion of breakfast)</time_frame>
      <description>Weighted amounts of ad-libitum food offered minus the weighted leftovers</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Glucose response</measure>
      <time_frame>During test day 1 (up to 4 hours)</time_frame>
      <description>Blood glucose response will be measured through blood samples collected via placed catheter before eating and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240 minutes)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glucose response</measure>
      <time_frame>During test day 2 (up to 4 hours)</time_frame>
      <description>Blood glucose response will be measured through blood samples collected via placed catheter before eating and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240 minutes)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin response</measure>
      <time_frame>During test day 1 (up to 4 hours)</time_frame>
      <description>Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240 minutes)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin response</measure>
      <time_frame>During test day 2 (up to 4 hours)</time_frame>
      <description>Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240 minutes)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastric emptying rate</measure>
      <time_frame>During test day 1 (up to 4 hours)</time_frame>
      <description>Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastric emptying rate</measure>
      <time_frame>During test day 2 (up to 4 hours)</time_frame>
      <description>Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective stress ratings</measure>
      <time_frame>During test day 1 (up to 4 hours)</time_frame>
      <description>Subjective stress, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).&#xD;
  Measurements will be takem: before eating (i.e. -15 minute) and at respective time points after completion of test meal (I.e. 0, 60, 120, 180, 240 minutes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective stress ratings</measure>
      <time_frame>During test day 2 (up to 4 hours)</time_frame>
      <description>Subjective stress, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).&#xD;
  Measurements will be takem: before eating (i.e. -15 minute) and at respective time points after completion of test meal (I.e. 0, 60, 120, 180, 240 minutes).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity questionnaire</measure>
      <time_frame>At the end of test day 1</time_frame>
      <description>Questionnaire about habitual physical activity over the past 1 week. Subjects will have to report how many days per week and for how many minus they perform vigorous, moderate or relaxed physical activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity questionnaire</measure>
      <time_frame>At the end of test day 2</time_frame>
      <description>Questionnaire about habitual physical activity over the past 1 week. Subjects will have to report how many days per week and for how many minus they perform vigorous, moderate or relaxed physical activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)</measure>
      <time_frame>At the end of test day 1</time_frame>
      <description>Mood related questionnaires over the past 1 week. Subjects will have to evaluate the extent they have felt certain feelings over the past week. Score will vary between 1 (Very slightly or not at all) to 5 (Extremely).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)</measure>
      <time_frame>At the end of test day 2</time_frame>
      <description>Mood related questionnaires over the past 1 week. Subjects will have to evaluate the extent they have felt certain feelings over the past week. Score will vary between 1 (Very slightly or not at all) to 5 (Extremely).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)</measure>
      <time_frame>At the end of test day 1</time_frame>
      <description>Mood related questionnaires over the past 1 week. Subjects will have to evaluate how ofter have felt certain feelings over the past week. Score will vary between 0 (Never) to 4 (Very often).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)</measure>
      <time_frame>At the end of test day 2</time_frame>
      <description>Mood related questionnaires over the past 1 week. Subjects will have to evaluate how ofter have felt certain feelings over the past week. Score will vary between 0 (Never) to 4 (Very often).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)</measure>
      <time_frame>At the end of test day 1</time_frame>
      <description>Mood related questionnaires over the past 1 week. Subjects will have to evaluate es how much the statement applied to them over the last week. Score will vary between 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)</measure>
      <time_frame>At the end of test day 2</time_frame>
      <description>Mood related questionnaires over the past 1 week. Subjects will have to evaluate es how much the statement applied to them over the last week. Score will vary between 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Appetite</condition>
    <condition>Satiety</condition>
    <condition>Energy Intake</condition>
    <condition>Glucose Response</condition>
    <condition>Insulin Response</condition>
    <condition>Gastric Emptying</condition>
    <arm_group>
      <arm_group_label>Control Bread: Wholemeal Yeast Bread</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Wholemeal bread, containing mainly of wholemeal flour, water and bakers' yeast will be used as the control test bread.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wholemeal Sourdough Bread</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Wholemeal sourdough bread, containing mainly of wholemeal flour, water and added sourdough co-culture (consisting of W.anom.+ C.crust strain).</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Dietary Intervention with Wholemeal Bread with Yeast</intervention_name>
      <description>Single administration of 150g wholemeal long-time processed bread with baker's yeast, with no lactic acid (control).</description>
      <arm_group_label>Control Bread: Wholemeal Yeast Bread</arm_group_label>
      <arm_group_label>Wholemeal Sourdough Bread</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Dietary Intervention with Wholemeal Sourdough Bread</intervention_name>
      <description>Single administration of 150g wholemeal long-time processed sourdough bread (with alternative lactic acid bacteria and yeast) high in lactic acid concentration.</description>
      <arm_group_label>Control Bread: Wholemeal Yeast Bread</arm_group_label>
      <arm_group_label>Wholemeal Sourdough Bread</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female and male participants&#xD;
  &#xD;
            -  age range 18 - 50&#xD;
  &#xD;
            -  BMI range 18.5 - 25.0 kg/m2 at screening visit&#xD;
  &#xD;
            -  Regular eating pattern (3 meals per day on at least 5 days per week)&#xD;
  &#xD;
            -  Stable body weight for the last 6 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently smoking (has smoked in the last 28 days) or willingness to smoke during the&#xD;
               study period&#xD;
  &#xD;
            -  Pregnancy, lactation or wish to become pregnant during the study period&#xD;
  &#xD;
            -  Family history of diabetes&#xD;
  &#xD;
            -  Previous or current gastrointestinal or endocrine disorders&#xD;
  &#xD;
            -  Previous or current substance/alcohol dependence or abuse (&gt; 2 units per day/14 units&#xD;
               per week)&#xD;
  &#xD;
            -  Coeliac disease or gluten sensitivity&#xD;
  &#xD;
            -  Use of pre- or probiotics within one month preceding the study&#xD;
  &#xD;
            -  Use of antibiotics within 3 months preceding the study&#xD;
  &#xD;
            -  Excessive concern about eating habits or body weight as evidenced from scores &lt; 18 on&#xD;
               the restraint and disinhibition subscales of the Three-Factor Eating Questionnaire&#xD;
               (Stunkard &amp; Messick, 1985)&#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>Kristin Verbeke, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>KU Leuven</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Georgia Chatonidi, MSc</last_name>
      <phone>+32 16 19 43 24</phone>
      <email>georgia.chatonidi@kuleuven.be</email>
    </overall_contact>
    <location>
      <facility>
        <name>KU Leuven/UZ Leuven</name>
        <address>
          <city>Leuven</city>
          <state>Vlaams Brabant</state>
          <zip>3000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <contact>
        <last_name>Georgia Chatonidi, MSc</last_name>
        <phone>+32 16 19 43 24</phone>
        <email>georgia.chatonidi@kuleuven.be</email>
      </contact>
      <investigator>
        <last_name>Kristin Verbeke, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>KU Leuven</investigator_affiliation>
      <investigator_full_name>Kristin Verbeke</investigator_full_name>
      <investigator_title>Full professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015867
  org study id: S64824 - B3222020000339
  nct id: NCT06015867
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  During this project the effect of yeast bread and sourdough breads consumption on satiety,
        energy intake at subsequent meal and postprandial metabolic responses, will be investigated.
  The primary aim of this study will be to evaluate the impact of an alternative starter
        culture that produces high levels of lactic acid on appetite regulation (subjective satiety
        and energy intake at the subsequent meal). The second aim will be to identify mechanistic
        parameters that may explain the observed effects, including glycaemic and insulin response,
        and gastric emptying rate. In addition, habitual physical activity levels, and mood and
        stress levels of the subjects will be evaluated as potential covariates of appetite
        regulation.
  
        It is hypothesized that:
  
        Sourdough breads fermented with the alternative starter culture that produce high
        concentrations of lactic acid will reduce glucose response via lower starch digestibility
        and/or slower gastric emptying rate. The reduced glycaemic response will lead to higher
        satiety and lower energy intake at the subsequent meal (more than 10%).
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Appetite measurements
  time frame: During test day 1 (up to 4 hours)
  description: Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).
  Measurements will be taken: before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
  measure: Appetite measurements
  time frame: During test day 2 (up to 4 hours)
  description: Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).
  Measurements will be taken: before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
  measure: Food intake at subsequent meal
  time frame: During test day 1 (240 minutes after ingestion of breakfast)
  description: Weighted amounts of ad-libitum food offered minus the weighted leftovers
  measure: Food intake at subsequent meal
  time frame: During test day 2 (240 minutes after ingestion of breakfast)
  description: Weighted amounts of ad-libitum food offered minus the weighted leftovers
  measure: Glucose response
  time frame: During test day 1 (up to 4 hours)
  description: Blood glucose response will be measured through blood samples collected via placed catheter before eating and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240 minutes)
  measure: Glucose response
  time frame: During test day 2 (up to 4 hours)
  description: Blood glucose response will be measured through blood samples collected via placed catheter before eating and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240 minutes)
  measure: Insulin response
  time frame: During test day 1 (up to 4 hours)
  description: Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240 minutes)
  measure: Insulin response
  time frame: During test day 2 (up to 4 hours)
  description: Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240 minutes)
  measure: Gastric emptying rate
  time frame: During test day 1 (up to 4 hours)
  description: Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
  measure: Gastric emptying rate
  time frame: During test day 2 (up to 4 hours)
  description: Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).
  measure: Subjective stress ratings
  time frame: During test day 1 (up to 4 hours)
  description: Subjective stress, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).
  Measurements will be takem: before eating (i.e. -15 minute) and at respective time points after completion of test meal (I.e. 0, 60, 120, 180, 240 minutes).
  measure: Subjective stress ratings
  time frame: During test day 2 (up to 4 hours)
  description: Subjective stress, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).
  Measurements will be takem: before eating (i.e. -15 minute) and at respective time points after completion of test meal (I.e. 0, 60, 120, 180, 240 minutes).
  measure: Physical activity questionnaire
  time frame: At the end of test day 1
  description: Questionnaire about habitual physical activity over the past 1 week. Subjects will have to report how many days per week and for how many minus they perform vigorous, moderate or relaxed physical activity.
  measure: Physical activity questionnaire
  time frame: At the end of test day 2
  description: Questionnaire about habitual physical activity over the past 1 week. Subjects will have to report how many days per week and for how many minus they perform vigorous, moderate or relaxed physical activity.
  measure: Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)
  time frame: At the end of test day 1
  description: Mood related questionnaires over the past 1 week. Subjects will have to evaluate the extent they have felt certain feelings over the past week. Score will vary between 1 (Very slightly or not at all) to 5 (Extremely).
  measure: Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)
  time frame: At the end of test day 2
  description: Mood related questionnaires over the past 1 week. Subjects will have to evaluate the extent they have felt certain feelings over the past week. Score will vary between 1 (Very slightly or not at all) to 5 (Extremely).
  measure: Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)
  time frame: At the end of test day 1
  description: Mood related questionnaires over the past 1 week. Subjects will have to evaluate how ofter have felt certain feelings over the past week. Score will vary between 0 (Never) to 4 (Very often).
  measure: Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)
  time frame: At the end of test day 2
  description: Mood related questionnaires over the past 1 week. Subjects will have to evaluate how ofter have felt certain feelings over the past week. Score will vary between 0 (Never) to 4 (Very often).
  measure: Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)
  time frame: At the end of test day 1
  description: Mood related questionnaires over the past 1 week. Subjects will have to evaluate es how much the statement applied to them over the last week. Score will vary between 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).
  measure: Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)
  time frame: At the end of test day 2
  description: Mood related questionnaires over the past 1 week. Subjects will have to evaluate es how much the statement applied to them over the last week. Score will vary between 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).
  arm group label: Control Bread: Wholemeal Yeast Bread
  arm group type: Active Comparator
  description: Wholemeal bread, containing mainly of wholemeal flour, water and bakers' yeast will be used as the control test bread.
  arm group label: Wholemeal Sourdough Bread
  arm group type: Active Comparator
  description: Wholemeal sourdough bread, containing mainly of wholemeal flour, water and added sourdough co-culture (consisting of W.anom.+ C.crust strain).
  intervention type: Dietary Supplement
  intervention name: Dietary Intervention with Wholemeal Bread with Yeast
  description: Single administration of 150g wholemeal long-time processed bread with baker's yeast, with no lactic acid (control).
  arm group label: Control Bread: Wholemeal Yeast Bread
  arm group label: Wholemeal Sourdough Bread
  intervention type: Dietary Supplement
  intervention name: Dietary Intervention with Wholemeal Sourdough Bread
  description: Single administration of 150g wholemeal long-time processed sourdough bread (with alternative lactic acid bacteria and yeast) high in lactic acid concentration.
  arm group label: Control Bread: Wholemeal Yeast Bread
  arm group label: Wholemeal Sourdough Bread
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kristin Verbeke, PhD
  role: Principal Investigator
  affiliation: KU Leuven
  last name: Georgia Chatonidi, MSc
  phone: +32 16 19 43 24
  email: georgia.chatonidi@kuleuven.be
  facility: 
  contact: 
  investigator: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: KU Leuven
  investigator full name: Kristin Verbeke
  investigator title: Full professor
  sharing ipd: No