<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/NCT03829189</url>
  </required_header>
  <id_info>
    <org_study_id>GUT_BRAIN</org_study_id>
    <nct_id>NCT03829189</nct_id>
  </id_info>
  <brief_title>High-fiber Diet on the Body and the Brain</brief_title>
  <official_title>Interventional Study Comparing the Effect of a High-fiber Supplement Versus Placebo on the Body and the Brain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Max Planck Institute for Human Cognitive and Brain Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Max Planck Institute for Human Cognitive and Brain Sciences</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>
      The central research question aims to understand what drives individuals to make and maintain&#xD;
      a vegan / vegetarian dietary decision, to investigate whether there are possible predictors&#xD;
      that might influence such a decision and whether personality differences already exist or can&#xD;
      only be measured after the change in diet. The investigators will examine the effects of a&#xD;
      high-fiber diet on food wanting on a neural and on a behavioral level. The microbiome is&#xD;
      suggested to mediate the expected changes in food wanting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">November 24, 2020</completion_date>
  <primary_completion_date type="Actual">November 24, 2020</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>
    <intervention_model_description>Arm 1: inulin; minimum of 14 days wash-out; 14 days placebo Arm 2: 14 days placebo; minimum of 14 days wash-out; 14 days placebo</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fMRI BOLD activity during food wanting</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>microbial alpha and beta diversity</measure>
    <time_frame>14 days</time_frame>
    <description>The taxonomic structure of the microbial community will be determined using 16S rRNA gene sequencing. The reads from the sequencing data will be assigned to taxa by sequence similarity using puplic available data bases. Relative distribution of microbial taxa is then based on the number of reads assigned to each taxa. For the description of the the community the alpha diversity of each sample will be determined based on species richness, evenness of species distribution which is combined in the single value of the Shannon diversity index. Furthermore beta-diversity, how the microbial communities differ between sample, will be analysed by principal component analysis as well as non-metric multidimensional scaling. In addition, for each taxa significant difference between sample groups will be assessed by comparing the relative number of reads.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fMRI BOLD activity memory performance</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>positive and negative affect</measure>
    <time_frame>14 days</time_frame>
    <description>PANAS (Positive and Negative Affect Schedule); scores can range from 10 - 50, with higher (lower) scores representing higher (lower) levels of positive (negative) affect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mood</measure>
    <time_frame>14 days</time_frame>
    <description>POMS (Profile of Mood States); four scales (Depression/Anxiety, Fatigue, Vigor, Anger), 35 items, 7 point scale, instruction &quot;How you have been feeling during the past 24 hours?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>emotional health</measure>
    <time_frame>14 days</time_frame>
    <description>BDI-II (Beck Depression Inventory); score minimum 0 to maximum 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>well-being</measure>
    <time_frame>14 days</time_frame>
    <description>WHO-5 (World Health Organization Well-Being Index); measures life quality and life contentment; score minimum 0 to maximum 5 with higher score representing higher life quality and life contentment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satiety</measure>
    <time_frame>14 days</time_frame>
    <description>self-reported hunger scale; visual analogue scale; score minimum 0 to maximum 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum lipid metabolism markers</measure>
    <time_frame>14 days</time_frame>
    <description>total cholesterol, triglycerides, high density lipoprotein, low density lipoprotein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum glucose metabolism markers</measure>
    <time_frame>14 days</time_frame>
    <description>glucose, insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum glucose metabolism markers</measure>
    <time_frame>14 days</time_frame>
    <description>long-term glucose marker HbA1C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum inflammatory markers</measure>
    <time_frame>14 days</time_frame>
    <description>high sensitivity C-reactive protein, interleukin-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hunger hormones</measure>
    <time_frame>14 days</time_frame>
    <description>leptin, ghrelin, Glucagon-like peptide-1 (GLP-1), peptide YY</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum microbial metabolic markers</measure>
    <time_frame>14 days</time_frame>
    <description>short-chain fatty acids (SCFA), trimethylamine N-oxide (TMAO), bile acids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>personality traits</measure>
    <time_frame>14 days</time_frame>
    <description>BFMM (BIG FIVE Mine Marker); measures the Big Five personality traits as states; 5 subscales (neuroticism, extraversion, openness, agreeableness, conscientiousness); higher scores means being more extreme for a certain state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gastrointestinal health</measure>
    <time_frame>14 days</time_frame>
    <description>GQLI-10 (Gastrointestinal Quality of Life Index); 10 items to measure quality of life regarding gastrointestinal symptoms; the higher the score the stronger the symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Diet Modification</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>inulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>inulin</intervention_name>
    <description>prebiotic supplement</description>
    <arm_group_label>inulin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>maltodextrin</intervention_name>
    <description>placebo supplement</description>
    <arm_group_label>maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body-mass-index 25-30kg/m^2&#xD;
&#xD;
          -  females on contraception only&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current neurological or psychiatric illness&#xD;
&#xD;
          -  daily consumption of more than 50 g of alcohol, more than 10 cigarettes or more than 6&#xD;
             cups of coffee&#xD;
&#xD;
          -  use of antidepressants or other centrally acting drugs&#xD;
&#xD;
          -  type 2 diabetes mellitus or other serious metabolic disorders&#xD;
&#xD;
          -  MRI contraindication (e.g. cardiac pacemaker, drug pump, shunts)&#xD;
&#xD;
          -  major untreated medical condition, including gastrointestinal organs, lungs, heart,&#xD;
             cardiovascular system, liver and kidney)&#xD;
&#xD;
          -  diet-related restrictions (food allergies, food intolerances, known nutrient&#xD;
             deficiencies or a recent history of dieting or restrictive eating behaviour, including&#xD;
             vegan, vegetarian diet)&#xD;
&#xD;
          -  current pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences</name>
      <address>
        <city>Leipzig</city>
        <state>Saxonia</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>November 25, 2020</last_update_submitted>
  <last_update_submitted_qc>November 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>microbiome</keyword>
  <keyword>food wanting</keyword>
  <keyword>memory</keyword>
  <keyword>fiber</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT03829189
org study id: GUT_BRAIN
nct id: NCT03829189
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The central research question aims to understand what drives individuals to make and maintain
      a vegan / vegetarian dietary decision, to investigate whether there are possible predictors
      that might influence such a decision and whether personality differences already exist or can
      only be measured after the change in diet. The investigators will examine the effects of a
      high-fiber diet on food wanting on a neural and on a behavioral level. The microbiome is
      suggested to mediate the expected changes in food wanting.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Arm 1: inulin; minimum of 14 days wash-out; 14 days placebo Arm 2: 14 days placebo; minimum of 14 days wash-out; 14 days placebo
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: fMRI BOLD activity during food wanting
time frame: 14 days
measure: microbial alpha and beta diversity
time frame: 14 days
description: The taxonomic structure of the microbial community will be determined using 16S rRNA gene sequencing. The reads from the sequencing data will be assigned to taxa by sequence similarity using puplic available data bases. Relative distribution of microbial taxa is then based on the number of reads assigned to each taxa. For the description of the the community the alpha diversity of each sample will be determined based on species richness, evenness of species distribution which is combined in the single value of the Shannon diversity index. Furthermore beta-diversity, how the microbial communities differ between sample, will be analysed by principal component analysis as well as non-metric multidimensional scaling. In addition, for each taxa significant difference between sample groups will be assessed by comparing the relative number of reads.
measure: fMRI BOLD activity memory performance
time frame: 14 days
measure: positive and negative affect
time frame: 14 days
description: PANAS (Positive and Negative Affect Schedule); scores can range from 10 - 50, with higher (lower) scores representing higher (lower) levels of positive (negative) affect
measure: mood
time frame: 14 days
description: POMS (Profile of Mood States); four scales (Depression/Anxiety, Fatigue, Vigor, Anger), 35 items, 7 point scale, instruction "How you have been feeling during the past 24 hours?"
measure: emotional health
time frame: 14 days
description: BDI-II (Beck Depression Inventory); score minimum 0 to maximum 21
measure: well-being
time frame: 14 days
description: WHO-5 (World Health Organization Well-Being Index); measures life quality and life contentment; score minimum 0 to maximum 5 with higher score representing higher life quality and life contentment
measure: satiety
time frame: 14 days
description: self-reported hunger scale; visual analogue scale; score minimum 0 to maximum 8
measure: serum lipid metabolism markers
time frame: 14 days
description: total cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
measure: serum glucose metabolism markers
time frame: 14 days
description: glucose, insulin
measure: serum glucose metabolism markers
time frame: 14 days
description: long-term glucose marker HbA1C
measure: serum inflammatory markers
time frame: 14 days
description: high sensitivity C-reactive protein, interleukin-6
measure: hunger hormones
time frame: 14 days
description: leptin, ghrelin, Glucagon-like peptide-1 (GLP-1), peptide YY
measure: serum microbial metabolic markers
time frame: 14 days
description: short-chain fatty acids (SCFA), trimethylamine N-oxide (TMAO), bile acids
measure: personality traits
time frame: 14 days
description: BFMM (BIG FIVE Mine Marker); measures the Big Five personality traits as states; 5 subscales (neuroticism, extraversion, openness, agreeableness, conscientiousness); higher scores means being more extreme for a certain state
measure: gastrointestinal health
time frame: 14 days
description: GQLI-10 (Gastrointestinal Quality of Life Index); 10 items to measure quality of life regarding gastrointestinal symptoms; the higher the score the stronger the symptoms
arm group label: inulin
arm group type: Active Comparator
arm group label: maltodextrin
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: inulin
description: prebiotic supplement
arm group label: inulin
intervention type: Dietary Supplement
intervention name: maltodextrin
description: placebo supplement
arm group label: maltodextrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Overweight