<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/NCT04457791</url>
  </required_header>
  <id_info>
    <org_study_id>NL73256.028.20</org_study_id>
    <nct_id>NCT04457791</nct_id>
  </id_info>
  <brief_title>Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice</brief_title>
  <acronym>PAC</acronym>
  <official_title>Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maag Lever Darm Stichting</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TNO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sensus</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kellogg Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bolletje</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sonneveld</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roquette Freres</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nederlands Bakkerij Centrum</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wageningen Food and Biobased Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wageningen University</source>
  <oversight_info>
    <has_dmc>No</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>
      Rationale: constipation-related complaints are prevalent in 5-20% of the population.&#xD;
&#xD;
      Dietary fibers play a crucial role in improving and maintaining gut health, increasing stool&#xD;
      weight, stool frequency and improvement of stool consistency. Currently, very few adults meet&#xD;
      the recommendation of 30 (females) or 40 (males) grams of fiber per day. Personalized dietary&#xD;
      advice may be the solution to increase dietary fiber intake and reduce constipation-related&#xD;
      complaints in large populations. Objective: To investigate the effectiveness of personalized&#xD;
      dietary advice (PDA) in reducing constipation-related complaints, by increasing dietary fiber&#xD;
      intake in people with constipation-related complaints. Study design: This study has a&#xD;
      one-group pre-test post-test design with a run-in period.&#xD;
&#xD;
      The duration of the study is 8 weeks, which includes a 4-week run-in phase and a 4-week&#xD;
      intervention period. All subjects receive the PDA. Study population: adult subjects with&#xD;
      constipation-related complaints, defined as predominant Bristol stool form between 1-4 and&#xD;
      not satisfied with their bowel habits (scale ranging from 1-10, cut-off &lt;6). Possibly stool&#xD;
      frequency ≤4 stools per week will be included as a definition. Subjects need to have a&#xD;
      relatively low dietary fiber intake defined as &lt;26 grams (females) or &lt;33 grams (males),&#xD;
      which is ≥15% below the recommendation of fiber intake. Intervention: personalized advice&#xD;
      based on their habitual food pattern (as assessed using a food frequency questionnaire) and&#xD;
      preferences. Based on a special algorithm, the PDA provides high fiber alternatives for&#xD;
      low-fiber products that subjects currently use, close to their current eating behavior, to&#xD;
      help increase dietary fiber intake. This PDA will be provided using an online web-portal.&#xD;
&#xD;
      Main study parameters/endpoints:primary outcomes are stool pattern, gastrointestinal&#xD;
      complaints and constipation quality of life and severity. Secondary parameters include&#xD;
      dietary fiber intake, physical activity, body weight, psychological questionnaires, and fecal&#xD;
      microbiota composition and metabolite levels. Furthermore, the PDA will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2020</start_date>
  <completion_date type="Actual">November 2, 2020</completion_date>
  <primary_completion_date type="Actual">November 2, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>One group is followed over time (within person design)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>participants are not informed about the content and focus of the personalized dietary advice</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in constipation severity after 8 weeks</measure>
    <time_frame>Measured during week 1, week 4 and week 8</time_frame>
    <description>Will be measured using a validated questionnaire PAC-SYM, which has 12 items. Scores can range between 1 (not severe) and 4 points (vere severe)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in constipation related quality of life after 8 weeks</measure>
    <time_frame>Measured during week 1, week 4 and week 8</time_frame>
    <description>Will be measured using a validated questionnaire (PAC-QoL), which has 28-items</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stool pattern</measure>
    <time_frame>8 weeks</time_frame>
    <description>Will be assessed daily using a mobile phone application (using ecogological momentary assessment, EMA). Subjects will indicate each day whether they had defecation and which type of defecation it was (based on the bristol stool chart)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abdominal pain</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bloating</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flatulence</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured daily using a mobile phone application EMA, on a 100-point visual analog scale rangeing from not at all to very severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abdominal cramps</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary fiber intake</measure>
    <time_frame>during week 1, week 4 and week 8 of the study</time_frame>
    <description>Measured by 24hr recall. Each measurement will consist of 3 days to take variance into account (1 weekend day and 2 weekdays)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short fiber screening questionnaire</measure>
    <time_frame>At screening</time_frame>
    <description>Validation of a short fiber screening questionnaire: 18-item questionnaire assessing fiber intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laxative use</measure>
    <time_frame>Daily during 8 weeks</time_frame>
    <description>Measured daily using a mobile phone application EMA: did you use laxatives today. If yes: which laxative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>during week 1, week 4 and week 8</time_frame>
    <description>Will be measured by the validated short questionnaire to assess health-enhancing physical activity (SQUASH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>During week 1, week 4 and week 8</time_frame>
    <description>Measured during study visits on a weighing scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota composition from fecal samples, as assessed by 16S rRNA sequencing</measure>
    <time_frame>During week 1, week 4, and week 8</time_frame>
    <description>Will be measured from fecal samples taken by participants' at home</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>short-chain fatty acid levels from fecal samples, assessed by HPLC</measure>
    <time_frame>During week 1, week 4 and week 8</time_frame>
    <description>Will be measured from fecal samples taken by participants' at home</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validated subjective health questionnaire</measure>
    <time_frame>During week 1, week 4 and week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-regulation questionnaire</measure>
    <time_frame>During week 1, week 4 and week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intention to eat fibers questionnaire</measure>
    <time_frame>During week 1, week 4 and week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subjective knowledge of fibers questionnaire</measure>
    <time_frame>During week 1, week 4 and week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>outcome beliefs of fibers questionnaire</measure>
    <time_frame>During week 1, week 4 and week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-efficacy of fiber intake</measure>
    <time_frame>Daily during the intervention period of 4 weeks</time_frame>
    <description>Measured by the question: did you manage to eat more fiber today: on a 100-point visual analog scale from &quot;not at all&quot; to &quot;yes, completely&quot; using a mobile phone application on the phone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation questionnaire</measure>
    <time_frame>During week 8</time_frame>
    <description>That evaluates the personalized dietary advice</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Intervention phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>From week 5-8, participants will receive the intervention, namely personalized dietary advice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational phase</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>From week 1-4, participants will not receive any intervention, but just will be observed, to form as their own control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalized dietary advice</intervention_name>
    <description>Via an self-developed website and algorithm, participants will receive digital personalized dietary advice to increase dietary fiber intake, aiming to reduce constipation complaints. The advice is personalized on phenotype (habitual diet, gender)</description>
    <arm_group_label>Intervention phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18- 55 years&#xD;
&#xD;
          -  BMI &lt;30 kg/m2&#xD;
&#xD;
          -  Has constipation related complaints: response &lt;6 to the question &quot;how satisfied are&#xD;
             you with your stool pattern&quot;, which is rated on a visual analog scale (VAS) from 1-10,&#xD;
             together with at least one of the following criteria:&#xD;
&#xD;
               1. Habitual stool form of Bristol stool type 1-4 or&#xD;
&#xD;
               2. ≤4 defecations per week&#xD;
&#xD;
          -  living in the surroundings of wageningen (max. 50km)&#xD;
&#xD;
          -  in possession of a computer with chrome browser and a mobile phone compatible with&#xD;
             applications Note: these criteria are less stringent than the official &quot;constipation&quot;&#xD;
             definition, because we preferably want to include participants that do not use&#xD;
             laxatives (yet), and we assume that in this 'mild constipation' group increasing fiber&#xD;
             intake can have the most beneficial effects. Moreover, we chose not to use the Rome IV&#xD;
             criteria as definition of constipation-related complaints, due to the proven inability&#xD;
             to distinguish functional constipation from Irritable Bowel Syndrome. If there are&#xD;
             sufficient eligible participants, the participants with the lowest stool frequency&#xD;
             will be selected&#xD;
&#xD;
          -  Relatively low fiber intake (females &lt;26 grams, males &lt;33 grams). When enough eligible&#xD;
             participants are available, we will choose the participants with the lowest dietary&#xD;
             fiber intake.&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a disease that may interfere with the personal dietary advice or&#xD;
             outcomes, such as a known autonomic disorder, inflammatory bowel disease, coeliac&#xD;
             disease, cancer, dialysis patients, chronic kidney failure, depression or&#xD;
             hypothyroidism.&#xD;
&#xD;
          -  Currently following strict diet and unwilling or unable to change; for example a&#xD;
             gluten free diet or a &quot;crash diet&quot; using meal substitutes&#xD;
&#xD;
          -  Use of medication that can interfere with the study outcomes, including diuretics,&#xD;
             antidepressants, codeine, antibiotics or fiber supplements. Preferably laxative use is&#xD;
             excluded, but if recruitment is hurdled by this, we at least exclude specific&#xD;
             laxatives like resolor, relistor and constella. These are laxatives who have a&#xD;
             significant impact on bowel movements, and are only available on prescription. Osmotic&#xD;
             (over the counter available) laxatives will be included if recruitment is difficult.&#xD;
             Subjects will then be asked to keep their laxative use stable or reduce, but not to&#xD;
             increase usage from their habitual pattern (unless necessary, but then report it to&#xD;
             the researchers). Moreover, additional questions regarding laxative usage will be&#xD;
             included to estimate the effect of laxatives on stool pattern.&#xD;
&#xD;
          -  Female subjects: currently pregnant or breastfeeding, or intending to become pregnant&#xD;
             during the study, as this can affect stool patterns and wellbeing.&#xD;
&#xD;
          -  Are simultaneously participating in another study.&#xD;
&#xD;
          -  Unwilling or unable to fulfil the study criteria.&#xD;
&#xD;
          -  Student or employee working at Food, Health and Consumer Research from Food and&#xD;
             Biobased Research, or Department of Human Nutrition &amp; Health, Wageningen University.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole de Wit, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen Food and Biobased Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wageningen University &amp; Research</name>
      <address>
        <city>Wageningen</city>
        <zip>6700AA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 19, 2021</last_update_submitted>
  <last_update_submitted_qc>January 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dietary fiber</keyword>
  <keyword>Personalized advice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04457791
org study id: NL73256.028.20
nct id: NCT04457791
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rationale: constipation-related complaints are prevalent in 5-20% of the population.

      Dietary fibers play a crucial role in improving and maintaining gut health, increasing stool
      weight, stool frequency and improvement of stool consistency. Currently, very few adults meet
      the recommendation of 30 (females) or 40 (males) grams of fiber per day. Personalized dietary
      advice may be the solution to increase dietary fiber intake and reduce constipation-related
      complaints in large populations. Objective: To investigate the effectiveness of personalized
      dietary advice (PDA) in reducing constipation-related complaints, by increasing dietary fiber
      intake in people with constipation-related complaints. Study design: This study has a
      one-group pre-test post-test design with a run-in period.

      The duration of the study is 8 weeks, which includes a 4-week run-in phase and a 4-week
      intervention period. All subjects receive the PDA. Study population: adult subjects with
      constipation-related complaints, defined as predominant Bristol stool form between 1-4 and
      not satisfied with their bowel habits (scale ranging from 1-10, cut-off <6). Possibly stool
      frequency ≤4 stools per week will be included as a definition. Subjects need to have a
      relatively low dietary fiber intake defined as <26 grams (females) or <33 grams (males),
      which is ≥15% below the recommendation of fiber intake. Intervention: personalized advice
      based on their habitual food pattern (as assessed using a food frequency questionnaire) and
      preferences. Based on a special algorithm, the PDA provides high fiber alternatives for
      low-fiber products that subjects currently use, close to their current eating behavior, to
      help increase dietary fiber intake. This PDA will be provided using an online web-portal.

      Main study parameters/endpoints:primary outcomes are stool pattern, gastrointestinal
      complaints and constipation quality of life and severity. Secondary parameters include
      dietary fiber intake, physical activity, body weight, psychological questionnaires, and fecal
      microbiota composition and metabolite levels. Furthermore, the PDA will be evaluated.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: One group is followed over time (within person design)
primary purpose: Treatment
masking: Single (Participant)
masking description: participants are not informed about the content and focus of the personalized dietary advice
measure: Change in constipation severity after 8 weeks
time frame: Measured during week 1, week 4 and week 8
description: Will be measured using a validated questionnaire PAC-SYM, which has 12 items. Scores can range between 1 (not severe) and 4 points (vere severe)
measure: Change in constipation related quality of life after 8 weeks
time frame: Measured during week 1, week 4 and week 8
description: Will be measured using a validated questionnaire (PAC-QoL), which has 28-items
measure: Stool pattern
time frame: 8 weeks
description: Will be assessed daily using a mobile phone application (using ecogological momentary assessment, EMA). Subjects will indicate each day whether they had defecation and which type of defecation it was (based on the bristol stool chart)
measure: Abdominal pain
time frame: 8 weeks
description: Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
measure: Bloating
time frame: 8 weeks
description: Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
measure: Flatulence
time frame: 8 weeks
description: Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
measure: Fatigue
time frame: 8 weeks
description: Measured daily using a mobile phone application EMA, on a 100-point visual analog scale rangeing from not at all to very severe
measure: Abdominal cramps
time frame: 8 weeks
description: Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
measure: Dietary fiber intake
time frame: during week 1, week 4 and week 8 of the study
description: Measured by 24hr recall. Each measurement will consist of 3 days to take variance into account (1 weekend day and 2 weekdays)
measure: Short fiber screening questionnaire
time frame: At screening
description: Validation of a short fiber screening questionnaire: 18-item questionnaire assessing fiber intake
measure: Laxative use
time frame: Daily during 8 weeks
description: Measured daily using a mobile phone application EMA: did you use laxatives today. If yes: which laxative
measure: Physical activity level
time frame: during week 1, week 4 and week 8
description: Will be measured by the validated short questionnaire to assess health-enhancing physical activity (SQUASH)
measure: Body weight
time frame: During week 1, week 4 and week 8
description: Measured during study visits on a weighing scale
measure: Microbiota composition from fecal samples, as assessed by 16S rRNA sequencing
time frame: During week 1, week 4, and week 8
description: Will be measured from fecal samples taken by participants' at home
measure: short-chain fatty acid levels from fecal samples, assessed by HPLC
time frame: During week 1, week 4 and week 8
description: Will be measured from fecal samples taken by participants' at home
measure: Validated subjective health questionnaire
time frame: During week 1, week 4 and week 8
measure: Self-regulation questionnaire
time frame: During week 1, week 4 and week 8
measure: intention to eat fibers questionnaire
time frame: During week 1, week 4 and week 8
measure: subjective knowledge of fibers questionnaire
time frame: During week 1, week 4 and week 8
measure: outcome beliefs of fibers questionnaire
time frame: During week 1, week 4 and week 8
measure: self-efficacy of fiber intake
time frame: Daily during the intervention period of 4 weeks
description: Measured by the question: did you manage to eat more fiber today: on a 100-point visual analog scale from "not at all" to "yes, completely" using a mobile phone application on the phone
measure: Evaluation questionnaire
time frame: During week 8
description: That evaluates the personalized dietary advice
arm group label: Intervention phase
arm group type: Experimental
description: From week 5-8, participants will receive the intervention, namely personalized dietary advice.
arm group label: Observational phase
arm group type: No Intervention
description: From week 1-4, participants will not receive any intervention, but just will be observed, to form as their own control
intervention type: Behavioral
intervention name: Personalized dietary advice
description: Via an self-developed website and algorithm, participants will receive digital personalized dietary advice to increase dietary fiber intake, aiming to reduce constipation complaints. The advice is personalized on phenotype (habitual diet, gender)
arm group label: Intervention phase
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Nicole de Wit, PhD
role: Principal Investigator
affiliation: Wageningen Food and Biobased Research
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Constipation
sharing ipd: Undecided